Lantern
®
Hip Instructions for Use: 001542-US Rev BA (06/2026)
Page 1 of 6
LANTERN
®
HIP
INSTRUCTIONS FOR USE
OrthAlign, Inc.
153 Technology
Irvine, CA, 92618 USA
www.orthalign.com
CAUTION
Federal (USA) law restricts this device to sale by or on the
order of a physician
HOW SUPPLIED
Lantern
®
Hip (includes reference sensor CR2 battery and femur
sensor battery).
Lantern Hip Instruments:
Lantern Hip instruments are provided NON-STERILE and must be
cleaned and sterilized prior to each use.
INDICATIONS FOR USE
Lantern Hip is a computer-controlled system intended to assist the
surgeon in determining reference alignment axes in relation to
anatomical and instrumentation structures during stereotactic
orthopedic surgical procedures. Lantern Hip facilitates the accurate
positioning of implants relative to these alignment axes. The system
aids the surgeon in controlling leg length and offset discrepancies.
Lantern Hip is indicated for Total Hip Arthroplasty with the Direct
Anterior Approach and the patient in the supine position, or through a
posterior-based approach with the patient in the lateral position. Note,
offset is only available with the Direct Anterior Approach.
INTENDED USE
Lantern Hip is designed to assist the physician in obtaining the
following during orthopedic surgical procedures:
Total Hip Arthroplasty
• Acetabular shell orientations ranging from 0-30° anteversion and
25-55° abduction.
• Measurement of the change in leg length within ±15mm of the
initial registration position (available with the patient in the supine
or lateral position).
• Measurement of the change in lateral offset within ±15mm of the
initial registration position (available only with the patient in the
supine position).
DESCRIPTION
Lantern Hip is a computer-assisted surgery device designed to assist
the surgeon during Total Hip Arthroplasty.
For the Direct Anterior Approach and the patient in the supine
position, Lantern Hip assists the surgeon in:
• Navigating acetabular cup inclination and anteversion
• Measuring changes in leg length and offset
• Establishing the orientation of the pelvic plane and determining
the abduction (inclination) angle and the anteversion angle of the
shell impactor relative to the anterior pelvic plane in total hip
arthroplasty, or to a reference frame adjusted for pelvic tilt in total
hip arthroplasty: anterior approach.
• Measuring the change in femoral position in both the superior-
inferior, and the medial-lateral directions, from the native
anatomic state to the post joint reduction state in total hip
arthroplasty.
Lantern Hip does not display measurement values when it is oriented
outside of its operating range.
For posterior-based approaches and the patient in the lateral position,
Lantern Hip assists the surgeon in:
• Navigating acetabular cup inclination and anteversion.
• Measuring changes in leg length.
• Establishing the orientation of the pelvic plane and determining
the abduction (inclination) angle and the anteversion angle of the
shell impactor relative to the coronal plane in total hip
arthroplasty.
• Measuring the change in femoral position in the superior-inferior
direction from the native anatomic state to the post joint reduction
state in total hip arthroplasty.
Lantern Hip does not display measurement values when it is oriented
outside of its operating range.
Lantern Hip consists of the sterile, single-use Lantern Hip Navigation
Unit (packaging includes reference sensor CR2 battery and femur
sensor battery) and associated reusable instrumentation supplied
non-sterile.
The Lantern Hip Navigation Unit is sterile unless package is opened
or damaged. The Lantern Hip Navigation Unit is for single use only.
For total hip arthroplasty, the Lantern Hip Navigation Unit is used in
conjunction with the Lantern Hip Instrument Set.
Lantern Hip provides measurement accuracy of ±3.0º with at least
95% confidence when measuring the angle of the shell impactor
relative to the frame of reference defined by the registered landmarks.
This measurement accuracy does not incorporate other sources of
error that are known to affect the overall shell placement accuracy,
such as variability in selection of the landmarks.
For the Direct Anterior Approach and the patient in the supine
position, Lantern Hip has been validated in bench testing to achieve
acetabular shell navigation accuracy, relative to an adjusted
reference frame (the APP rotated to correct for pelvic tilt) of ±3.0° with
95% confidence for abduction and ±3.0° with 95% confidence for
anteversion.
For the Direct Anterior Approach and the patient in the supine
position, Lantern Hip has been validated in bench testing to achieve
measurement accuracy of ±3.0mm with at least 95% confidence for
changes in femoral position in the superior-inferior direction (“leg
length”) and ±3.0mm with at least 95% confidence in the medial-
lateral direction (“offset”).
For posterior-based approaches and the patient in the lateral position,
Lantern Hip has been validated in bench testing to achieve acetabular
shell navigation accuracy, relative to a user-registered Coronal
reference frame of ±3.0° with 95% confidence for abduction and ±3.0°
with 95% confidence for anteversion.
For posterior-based approaches and the patient in the lateral position,
Lantern Hip has been validated in bench testing to achieve
measurement accuracy of ±3mm with 95% confidence for changes in
femoral position in the superior-inferior direction (“leg length”).
For measurement of change in femoral position, Lantern Hip directly
registers coordinates of a fiduciary fixated to the femur.
For The Direct Anterior Approach and the patient in the supine
position, Lantern Hip directly registers the anterior pelvic plane
defined by the following three points: left and right anterior superior
iliac spine and pubic tubercle. Shell impactor measurements are
displayed relative to this (APP) plane, or relative to a modification of
this plane rotated to correct for pelvic tilt.
For posterior-based approaches and the patient in the lateral position,
Lantern Hip establishes the coronal reference frame by registration of
patient positioning on the operating table. Shell impactor
measurements are displayed relative to this frame.
The Lantern Hip Instrument Set is comprised of registration jig,
adapter clips and clamps, reference sensor, femur sensor, hex driver,
femoral registration instruments, registration wand and associated
liner registration trials, and fixation pins. Lantern Hip instruments are
provided NON-STERILE and must be cleaned and sterilized prior to
each use.
Refer to the Lantern Hip Supine Surgical Technique Guide
(001391) and Lantern Hip Lateral Surgical Technique Guide
(001490) for detailed instructions on use of the instruments.
CONTRAINDICATIONS
Total Hip Arthroplasty
• In any hip arthroplasty procedures where there is a significant
loss of bone and the required landmarks cannot be identified or
there is severe deformity at the landmark sites. In cases of
previous pelvic fracture, previous pelvic osteotomy or severe
Lantern
®
Hip Instructions for Use: 001542-US Rev BA (06/2026)
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dysplasia, for example, the required landmarks should be
examined to ensure that severe deformity is not present.
• Atypical bony anatomy at the fixation site, extremely large or
small femurs, excessive soft tissue interference or severe
osteoporosis.
• The presence of infection.
• Any contraindication associated with hip arthroplasty surgery.
Early experience with these procedures should consider the technical
difficulty and complicated nature of this procedure and should be
restricted to straightforward cases. Contraindications may be relative
or absolute and must be carefully weighed against the patient’s entire
evaluation.
ADVERSE EFFECTS
Total Hip Arthroplasty
There is a possibility of implant malalignment. Depending on the
severity of the malalignment it may shorten the useful life of the
implant and increase the likelihood of impingement or dislocation. It
may impact a revision procedure. Lantern Hip is a tool to assist the
surgeon in judging the alignment and should not supersede the
surgeon's judgment.
There is a possibility of a leg length or offset discrepancy. Depending
on the severity of the discrepancy it may affect the clinical outcome
and/or patient satisfaction. Lantern Hip is a tool to assist the surgeon
in judging the femoral position and should not supersede the
surgeon's judgment. Lantern Hip contains instruments which have
magnetic attachments.
Possible adverse effects include heart rhythm disruption. There is a
possibility of a delay in the procedure from system issues. Other
possible adverse effects include infection, irritation, fever, pain, tissue
injury, foreign body reaction, electrical shock, burns, reduced joint
function, nerve damage and bone fracture.
WARNINGS
Warning: Do not resterilize the Lantern Hip Navigation Unit. This
product is provided sterile for single use only. It contains electronic
components that could be damaged. Discard any unused product.
Warning: Lantern Hip is not indicated for alignment in the attachment
of any device to the posterior elements of the cervical, thoracic, or
lumbar spine.
Warning: Replace the Lantern Hip Navigation Unit if dropped. Do not
use reference sensor if dropped. Do not use the femur sensor if
dropped. Replace and return to OrthAlign.
Warning: It is the surgeon’s responsibility to be familiar with this
technique prior to surgery. For further details, refer to the appropriate
surgical technique guide.
Warning: If sterile packaging is damaged, sterility may be
compromised. Do not use the device.
Warning: Remove battery from the reference sensor and/or femur
sensor if it is not intended to be used for some time.
Warning: Do not service reference sensor and/or femur sensor while
in use with a patient. If necessary, remove from patient to replace
battery.
Warning: No modification of this equipment is allowed.
Warning: The reference sensor and femur sensor can contain a
battery that needs to be removed and discarded prior to cleaning. If
battery is left in the reference sensor and/or femur sensor it could
damage instruments in the tray or the sterilizer equipment during
steam sterilization.
Warning: The instruments are designed for very specific tasks and
misuse may cause damage. Prior to use, check the instruments
thoroughly for wear or damage. Do not use damaged instruments as
they may compromise the surgical outcome. Replace damaged or
worn instruments before next use.
Warning: The instruments are provided clean, but not sterile, and
must be cleaned and sterilized prior to each use.
Warning: The strong magnetic fields near a neodymium magnet can
affect pacemakers, ICDs, and other implanted medical devices. Keep
instruments with magnets at least six inches away from any such
heart device.
Warning: The surface of the Lantern Hip Navigation Unit can reach
temperatures of up to 50°C.
Warning: The CR2 battery must be installed within the reference
sensor per the markings on the device. The correct polarity of battery
installation is clearly marked.
Warning: The femur sensor battery must be inserted in the correct
orientation and fully seated to power on the device.
INSTRUMENTS CLEANING AND STERILIZATION
For your own safety, be familiar with the procedures at your institution
for handling contaminated instruments before following these
instructions. Clean and sterilize all instruments prior to first use and
after every use. Refer to the Lantern Hip Surgical Technique Guide
for instructions on operation and dismantling of instrumentation.
DO NOT DISCARD OR DISASSEMBLE REFERENCE SENSOR
AND FEMUR SENSOR. REMOVE BATTERIES PRIOR TO
CLEANING.
Ultrasonic Cleaning Process
1. Remove and discard the battery from the reference sensor and
femur sensor.
2. Clean the instruments as soon as possible after use and avoid
allowing soiled instruments to dry. Immerse or use moist towels
or sponges soaked with distilled or de-ionized water to keep
moist prior to cleaning.
3. Disassemble instruments into their component parts and unlock
and extend levers as much as possible. Remove the battery
from the femur sensor and reference sensor. Keep battery
cover attached to reference sensor for cleaning and
sterilization.
4. Immerse into the prepared enzymatic detergent following the
detergent manufacturer’s instructions. Soak for five (5) minutes.
5. Actuate all moving parts of instruments, as applicable and use a
soft bristle brush and syringe to aid in cleaning all lumens,
crevices, and hard to reach areas. Ensure all visible soils are
removed.
6. Thoroughly rinse the devices under lukewarm running tap water
for a minimum of one (1) minute. Ensure all hard-to-reach areas
are flushed.
7. Fully immerse the instruments in an ultrasonic bath containing a
second enzymatic detergent prepared according to the
manufacturer’s instructions and sonicate for ten (10) minutes.
8. Thoroughly rinse the instruments with RO/DI water to remove all
detergent residues.
9. Dry the instruments with a clean, soft cloth. Filtered, pressurized
air can be used if applicable.
10. Visually examine each instrument for cleanliness. Inspect each
instrument with the naked eye under normal lighting conditions to
determine if all adherent visible soil (e.g., blood, protein
substances, and other debris) has been removed from surfaces,
lumens, crevices, and serrations, if applicable. If visible soil
remains, repeat the cleaning procedure until there is no adherent
visible soil.
Manual Cleaning Process
1. Remove and discard the battery from the reference sensor and
femur sensor.
2. Clean the instruments as soon as possible after use and avoid
allowing soiled instruments to dry. Immerse, or use moist towels
or sponges soaked with distilled or de-ionized water to keep
moist prior to cleaning.
3. Disassemble instruments into their component parts. Remove
the battery from the femur sensor and reference sensor.
Keep battery cover attached to reference sensor for cleaning
and sterilization.
4. Rinse the instruments under running cold utility (tap) water for 2
minutes.
5. Immerse into a prepared enzymatic detergent bath following the
detergent manufacturer’s instructions. Soak for 10 minutes.
6. Thoroughly rinse the devices under cold utility (tap) water for a
minimum of 2 minutes. Ensure all hard-to-reach areas are
flushed.
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Hip Instructions for Use: 001542-US Rev BA (06/2026)
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7. Immerse into a second prepared enzymatic detergent bath
following the detergent manufacturer’s instructions. Soak for 5
minutes.
8. While immersed, actuate all moving parts on instruments, as
applicable, and use a soft bristle brush and syringe to aid in
cleaning all lumens, crevices, and hard-to-reach areas. Ensure
all visible soils are removed.
9. Thoroughly rinse the instruments with RO/DI water to remove all
detergent residues for 2 minutes.
10. Dry the instruments with a clean, soft cloth. Filtered, pressurized
air can be used if applicable.
11. Visually examine each instrument for cleanliness. Inspect each
instrument with the naked eye under normal lighting conditions to
determine if all adherent visible soil (e.g. blood, protein
substances, and other debris) has been removed from the
surfaces, lumens, crevices, and serrations, if applicable. If visible
soil remains, repeat the cleaning procedure until there is no
adherent visible soil.
Note: Use of water-soluble lubricants is recommended for
instruments with moving parts or those intended to be assembled
intraoperatively to another instrument.
AUTOCLAVE STERILIZATION OF RE-USABLE INSTRUMENTS
Use FDA-cleared sterilization wraps or appropriate FDA-cleared
accessory that has been validated to allow sterilant penetration and to
subsequently maintain sterility.
Do not stack trays during sterilization.
• Wrapped pre-vacuum, four (4) minutes minimum at 270°F
(132°C). Minimum dry time is 50 minutes. Post cycle handling
may be necessary under ST79. Recommendation of 30-minute
wire rack cool down.
For emergency situations ONLY (e.g., intraoperative contamination):
• Unwrapped pre-vacuum (“Flash” or “Immediate Use”), four (4)
minutes minimum at 270°F (132°C)
Reference sensor and femur sensor must be cooled prior to use: 15
minutes minimum for air-cooling. The reference sensor and femur
sensor need to operate at room temperature. If sensors are still hot
from autoclave, they can be cooled in sterile water.
The recommended sterilization process has been validated to product
a sterility assurance level of (10
-6
) when parts have been cleaned to
the instructions above. Other steam cycles and cleaning procedures
have not been evaluated and must be qualified by the user.
Prior to use, inspect reference sensor and femur sensor for moisture
ingress. Do not use if moisture is detected.
Effective sterilization is predicated on thorough cleaning and drying
processes. Failure to do so will compromise the sterilization process
and render the processed instrument unsuitable for clinical use.
DISPOSAL
Do not throw Lantern Hip navigation unit in trash. Contains batteries
and electronic PCBs that must be disposed of per local regulations.
OPERATING CONDITIONS
Temperature: 15 to 25°C; Humidity: 10 to 70% RH; (non-condensing);
Pressure: 70 kPA to 106 kPA.
ELECTRICAL SAFETY
Protection against electrical shock:
INTERNALLY POWERED EQUIPMENT TYPE B APPLIED PART.
THE LANTERN HIP NAVIGATION UNIT IS STERILE ON RECEIPT.
ONE TIME USE – DO NOT ATTEMPT TO STERILIZE
EQUIPMENT NOT SUITABLE FOR USE IN THE PRESENCE OF A
FLAMMABLE ANAESTHETIC MIXTURE WITH AIR OR WITH
OXYGEN OR NITROUS OXIDE.
Device is battery operated. No connection to external power.
Mode of Operation: Continuous Operation, Battery life 2.5 hours.
This equipment has been tested and found to comply with the EMC
limits for the Medical Device Directive (EN 55011 Class A and EN
60601-1-2). These limits are designed to provide reasonable
protection against harmful interference in a typical medical
installation. The equipment generates, uses, and can radiate radio
frequency energy, and if not installed and used in accordance with
these instructions, may cause harmful interference to other devices in
the vicinity. However, there is no guarantee that interference will not
occur in a particular installation. If this equipment does cause harmful
interference with other devices, which can be determined by turning
the equipment off and on, the user is encouraged to try to correct the
interference by one or more of the following measures:
• Reorient or relocate receiving device.
• Increase the separation between the equipment.
• Consult OrthAlign or authorized representative for help.
IEC 60601-1-2:2014 Electromagnetic Compatibility Guidance
This section provides the appropriate specification tables for Lantern
Hip as per IEC 60601-1-2.
Table 1 Manufacturer’s Declaration – Electromagnetic Emissions
Lantern Hip is intended for use in the electromagnetic environment
specified below. The customer or user of Lantern Hip should assure that it
is used in such an environment.
Emissions Test
Compliance Level
RF Emissions CISPR 11
Group 1
Class A
Table 2 Manufacturer’s Declaration – Electromagnetic Immunity
Lantern Hip is intended for use in the electromagnetic environment
specified below. The customer or user of Lantern Hip should assure that it
is used in such an environment.
Immunity Test
IEC 60601 Test Level
Compliance Level
Electrostatic discharge
(ESD)
IEC 61000-4-2
±8kV contact
±2kV, ±4kV, ±8kV,
±15kV air
±8kV contact
±2kV, ±4kV, ±8kV,
±15kV air
Radiated RF
IEC 61000-4-3
3 V/m
80MHz to 6000 MHz
3 V/m
80MHz to 6000 MHz
Power frequency
(50/60 Hz) magnetic
field immunity
IEC 61000-4-8
30 A/m
30 A/m
Caution: Use of this equipment adjacent to or stacked with other
equipment should be avoided because it could result in improper
operation. If such use is necessary, the equipment and other
equipment should be observed to verify that they are operating
normally.
Caution: This equipment controls portable RF communications
equipment which may affect medical electric equipment. This
equipment should be used no closer than 40cm (16in) to any part of
other medical electrical equipment or medical electrical systems.
NOTE: The EMISSIONS characteristics of this equipment make it
suitable for use in industrial areas and hospitals (CISPR 11 Class A).
If it is used in a residential environment this equipment might not offer
adequate protection to radio-frequency communication services. The
user might need to take mitigation measures, such as relocating or
reorienting the equipment.
FCC ID: 2AVMS-406012 (Navigation Unit), FCC ID: RYYEYSGCN
(Reference Sensor), and FCC ID: SQGBL653U (Femur Sensor).
This device complies with Part 15 of the FCC Rules. Operation is
subject to the following two conditions: (1) This device may not cause
harmful interference and (2) this device must accept any interference
received, including interference that may cause undesired operation.
The maximum transmitted power is 8dBm
STORAGE AND TRANSPORTATION
Temperature: -30 to 60 ºC; Humidity: 10 to 95% RH; (non-
condensing); Pressure: 60 kPa to 101 kPa.
Handle with care. Products should be stored in a clean, cool, dry
area, away from chemical fumes.
CYBERSECURITY INFORMATION AND SECURE USE GUIDANCE
This section provides cybersecurity transparency information for
Lantern Hip and associated system components. The information in
this section is intended to help healthcare providers and users
understand the system’s cybersecurity protections and how to
operate the system securely.
Cybersecurity is a shared responsibility between OrthAlign,
healthcare providers, and users of Lantern Hip. This section
describes the system’s built-in cybersecurity protection and provides
guidance for secure operation throughout the device lifecycle.
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Caution: Changes or modifications not expressly approved by the
party responsible for compliance could void the user’s authority to
operate the equipment.
1. SYSTEM OVERVIEW
Lantern Hip is a computer-assisted surgical navigation system
intended to assist surgeons during knee or hip arthroplasty
procedures. The system provides intraoperative guidance to assist
surgeons in determining alignment axes and positioning
instrumentation relative to anatomical structures. Lantern Hip consists
of the following primary components:
Component
Description
Single-Use
Navigation Unit
Sterile, single-use navigation device running
custom software that provides surgical workflows
and a touchscreen user interface.
Reference
Sensor
Reusable wireless inertial sensor used to measure
orientation and motion during surgical procedures
Femur Sensor
Reusable wireless sensor used during hip procedures to
provide additional alignment and positioning information
During operation, the Navigation Unit communicates wirelessly with
the Reference Sensor and Femur Sensor using Bluetooth Low
Energy (BLE). The Navigation Unit uses Reference and Femur
Sensor transmitted data to calculate and display surgical alignment
information.
The Navigation Unit is intended for single use and is shipped in sterile
packaging sealed with tamper-evident materials.
The Reference Sensor and Femur Sensor are reusable devices with
limited authorized use counts enforced internally by the system.
Lantern Hip is designed to operate as a standalone surgical
navigation system and does not require connection to hospital
networks or external information systems during normal clinical
operation.
2. CONNECTIVITY AND INTERFACES
Lantern Hip uses limited connectivity designed specifically for
communication between authorized system components and
authorized servicing activities. The following interfaces are present
within the system hardware:
Interface
Purpose
Direction
Notes
Bluetooth
Low
Energy
(BLE)
Communication
between Navigation
Unit, Reference
Sensor, and Femur
Sensor
Bidirectional
Primary wireless
interface used
during clinical
operation
Wi-Fi
Manufacturing
configuration and
software servicing
activities
Bidirectional
Disabled in fielded
clinical devices and
not used during
surgical procedures
USB /
UART
service
interfaces
Manufacturing
programming,
diagnostics, and
servicing operations
Bidirectional
Restricted to
authorized OrthAlign
manufacturing and
service personnel
BLE communication supports transmission of:
• Alignment and orientation data
• Sensor status information
• System operational status
• Diagnostic event information
The system does not require hospital network connectivity for clinical
use.
3. BULT-IN CYBERSECURITY FEATURES
Lantern Hip incorporates multiple cybersecurity protections intended
to maintain software integrity, preserve system functionality, and
prevent unauthorized modification or misuse.
OPERATING SYSTEM SECURITY
The Navigation Unit operates using a customized Android-based
software platform configured with multiple operating system security
protections, including:
• Security Enhanced Linux (SELinux) operating in enforcing
mode
• Mandatory access control policies applied to system
processes
• Restriction of hardware access to authorized signed
applications only
• Disabled Android Debug Bridge (ADB) and serial debugging
interfaces during clinical use
• Disabled Wi-Fi programming interface following
manufacturing activities
These protections help prevent unauthorized applications or software
components from executing on the device.
SOFTWARE AND FIRMWARE INTEGRITY PROTECTIONS
The system incorporates mechanisms intended to ensure only
authorized software and firmware can execute on system
components. Examples include:
• Operating system and application signing on the Navigation
Unit
• Bootloader verification of firmware authenticity
• Cryptographic verification of firmware updates using ECDSA
P-256 digital signatures
• Dm-verity integrity verification on the Navigation Unit file
system
Firmware updates that fail integrity or authenticity verification are
rejected.
WIRELESS DEVICE AUTHENTICATION
The Navigation Unit will only recognize and communicate with
approved Reference Sensors and Femur Sensors configured within
an internal whitelist of authorized Bluetooth device addresses.
This control helps reduce the risk of unauthorized wireless devices
communicating with the Navigation System.
PHYSICAL ANTI-TAMERING PROTECTIONS
The Navigation Unit is shipped in sterile packaging sealed with
tamper-evident materials and a sterilization indicator sticker.
Users should inspect the packaging and tamper-evident indicators
prior to use. Evidence of damaged packaging or tampering may
indicate the device has been compromised, and the system should
not be used clinically.
SELF-TEST AND INTEGRITY MONITORING
The system performs validation checks during startup and operation
to verify proper device functionality. Examples include:
• Firmware integrity validation
• Electrical self-tests
• Power voltage monitoring
• Sensor communication verification
• Stale or invalid IMU data detection
• Calibration data validation
• BLE communication monitoring
If required checks fail, the system may display an error condition,
sever communication between devices, or prevent clinical operation.
4. EVENT DETECTION AND LOGGING
Lantern Hip records operational and diagnostic events during use to
support troubleshooting and service activities. Examples of logged
events include:
• BLE connection and disconnection events
• Communication interruptions
• Device fault conditions
• Startup validation failures
• Diagnostic event information
The Navigation Unit records Reference and Femur Sensor BLE link
event information that may be used by OrthAlign service personnel for
troubleshooting or device investigation.
5. PROTECTION OF CRITICAL FUNCTIONALITY
Lantern Hip incorporates safeguards to maintain safe device
operation under abnormal conditions or communication failures.
Examples include:
• Prevention of angle display when communication is
interrupted
• Detection of unstable sensor conditions
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• Hardware watchdog functionality that automatically resets
the Navigation Unit processor if required system heartbeat
signals are not detected
• Integrity checks that prevent execution of unauthorized
firmware
• Fault notifications are presented to the user when system
abnormalities are detected
If communication with the Reference Sensor is lost, the Navigation
Unit will display alignment information only after communication is
restored and system stability is verified.
6. USE COUNT ENFORCEMENT AND LIMITED SERVICE LIFE
Lantern Hip incorporates controls intended to prevent use beyond the
validated service life of each device component. Examples include:
• The Navigation Unit is limited to a single authorized use
• The Reference Sensor contains a limited number of
authorized uses
• The Femur Sensor contains a limited number of authorized
uses
Following completion of a procedure, the system decrements the
remaining authorized use count stored internally on the applicable
devices. Devices with no remaining authorized uses will not be
permitted to operate further.
7. SOFTWARE UPDATES AND MAINTENANCE
Software and firmware updates for Lantern Hip are controlled by
OrthAlign. The system is designed with a limited operational lifespan
and is not intended to receive software or firmware updates during
deployed clinical operation.
Manufacturing and servicing activities involving software loading or
programming are restricted to OrthAlign or authorized OrthAlign
service personnel. Firmware loaded during manufacturing is
authenticated and verified prior to installation to ensure integrity and
authenticity.
Users should contact OrthAlign customer support regarding any
servicing or cybersecurity-related questions.
8. SECURE OPERATION GUIDANCE
Users should follow the recommendations below to help maintain safe
and secure operation of the system:
• Use only OrthAlign-approved system components
• Use only approved Reference Sensors and Femur Sensors
with the Navigation Unit
• Inspect sterile packaging and tamper-evident seals prior to
use
• Do not use devices with damaged packaging or evidence of
tampering
• Do not attempt to modify device hardware, firmware, or
software
• Do not connect unauthorized accessories, programming
tools, or diagnostic equipment to device interfaces
• Follow OrthAlign instructions for handling, servicing, storage,
and disposal of reusable components
• Remove devices from service if repeated communication
failures or abnormal system behaviors are observed
Unauthorized modification of the system may affect system
functionality, cybersecurity protection, and patient safety.
9. DATA HANDLING
Lantern Hip does not store patient-identifiable clinical data.
Information stored on the system is limited to operational and device-
related information, such as:
• Device configuration data
• Diagnostic logs
• Calibration information
• Operational status information
• Remaining authorized use counts
The system is not intended to store Protected Health Information
(PHI) or Personally Identifiable Information (PII).
10. VULNERABILITY REPORTING
OrthAlign maintains processes for evaluating and responding to
cybersecurity vulnerabilities and reported security concerns.
Users who identify suspected cybersecurity issues, abnormal device
behavior, or potential vulnerabilities should contact OrthAlign
customer support using the contact information on the device label.
OrthAlign evaluates reported issues and may provide additional
guidance, servicing recommendations, or safety communications
when appropriate.
11. DEVICE DECOMMISSIONING AND DISPOSAL
When removing system components from service:
1. Dispose of single-use Navigation Units after completion of
the authorized procedure in accordance with local
regulations governing electronic medical devices and
batteries.
2. Dispose of reusable components after the authorized use
count has been exhausted or if the device becomes
damaged or nonfunctional.
3. Contact OrthAlign for additional disposal or return
instructions if required.
Because the system does not store PHI or PII, decommissioning
activities are limited primarily to device retirement and disposal rather
than data sanitization activities.
12. ADDITIONAL CYBERSECURITY DOCUMENTATION
Additional cybersecurity documentation may be available from
OrthAlign upon request, including:
• Manufacturer Disclosure Statement for Medical Device
Security (MDS2)
• Software Bill of Materials (SBOM) information
• Cybersecurity advisories
• Servicing guidance
• Safety notifications
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FOR FURTHER INFORMATION
If further information on this product is needed or you wish to obtain a
return product authorization, please contact OrthAlign Customer
Service at toll free 866-582-0879 or 949-715-2424 (available PST
8:00 a.m. - 5:00 p.m.) in the USA or your authorized representative,
or at [email protected]
Lantern
®
is a registered trademark of OrthAlign Inc.
Made in USA © 2026, OrthAlign, Inc.
OrthAlign, Inc.
153 Technology
Irvine, CA, 92618 USA
www.orthalign.com
SYMBOL LEGEND
Caution, See Instructions for Use
Warning:
Warning: Indicate instructions present to
avoid potentially serious injury to the patient
and/or user of the system.
Note: Indicate information which may be
valuable to the user in improving efficiency
and/or general usability of the system.
Manufacturer
Serial Number
Catalog Number
QTY
Quantity of Units
CONF
Configuration
SW
Software
SW P/N
Software Part Number
R
x
Only
Caution: Federal (USA) law restricts this
device to sale by or on the order of a
physician
Sterilized Using Ethylene Oxide
Battery Operated
Class B Installation
Do Not Dispose in Trash (WEEE)
Keep Dry
Storage Temperature
Fragile Handle with Care
Expiration Date
Do Not Reuse
Follow Instructions for Use
Consult Instructions for Use
Do Not Impact
FCC ID: XXXXX- XXXXXX
This device complies with Part 15 of the
FCC rules. Operation is subject to the
following two conditions:
(1) Device must not cause harmful
interference
(2) Device must accept any interference
received, including interference that may
cause undesired operation.
