Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a computer-assisted surgical navigation system that uses sensors and a computer module for positional information and calculations, but it does not mention or describe any AI/ML components or functionalities.

Therapeutic

No
The device aids the surgeon in accurately positioning implants and controlling discrepancies, acting as a tool to facilitate surgical procedures rather than directly providing therapy.

Diagnostic

No

Explanation: The device is a computer-assisted surgical navigation system used during orthopedic procedures to assist surgeons in determining alignment axes and positioning implants. It aids in controlling leg length and offset discrepancies and ligament balancing, which are functions related to guiding treatment rather than diagnosing a condition.

SaMD (Software as a Medical Device)

No

The device description explicitly states it comprises a "palm-sized computer module and reference sensor" and "reusable instrumentation," indicating hardware components beyond just software. The performance studies also include "System hardware verification/validation testing."

IVD (In Vitro Diagnostic)

Based on the provided information, the OrthAlign Plus® System is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states that the system is "intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures." This describes a device used during surgery to guide the surgeon, not a device used to test samples outside the body to diagnose or monitor a condition.
Device Description: The description reinforces this by calling it a "non-invasive computer assisted surgical navigation system." It measures and displays positional information in orthopedic procedures.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), performing tests on these samples, or providing diagnostic information based on such tests. The system focuses on anatomical alignment and instrument positioning during surgery.

Therefore, the OrthAlign Plus® System falls under the category of a surgical navigation or guidance system, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The OrthAlign Plus® System 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. The OrthAlign Plus® System facilitates the accurate positioning of implants, relative to these alignment axes. The system aids the surgeon in controlling leg length and offset discrepancies in Total Hip Arthroplasty. Ligament balancing is provided by the OrthAlign Plus® System in primary or revision Total Knee Arthroplasty.

Example orthopedic surgical procedures include but are not limited to:

Total Knee Arthroplasty
Total Hip Arthroplasty: Anterior/Posterior
Unicompartmental Knee Arthroplasty: Tibial transverse resection
Ligament Balancing

Product codes

OLO

Device Description

The OrthAlign Plus® System is a non-invasive computer assisted surgical navigation system for use in knee and hip arthroplasty procedures. The OrthAlign Plus® System is configured to detect, measure, and display angular and positional measurement changes in a triaxial format. The OrthAlign Plus® System utilizes a palm-sized computer module and reference sensor to generate positional information in orthopedic procedures providing a sequence of steps for registration of anatomical landmarks, calculation of mechanical axes, and positioning of instruments relative to the mechanical axes.

In knee arthroplasty procedures, the device assists the surgeon in:

Establishing the mechanical axis of the femur, determining the varus/valgus angle and the flexion/extension angle of the cutting block relative to the femur.
Establishing the mechanical axis of the tibia, determining the varus/valgus and the posterior slope angle of the cutting block relative to the tibia.
Measuring the angles and gap distances between the femur and proximal tibia, for use in ligament balancing and establishing a reference line to assist in setting the rotation of the femoral implant, in primary or revision procedures.

In hip arthroplasty procedures, the device assists the surgeon in:

Establishing the orientation of the anterior pelvic plane and determining the inclination angle and the anteversion angle of the shell impactor relative to the anterior pelvic plane, or to the anterior pelvic plane adjusted for pelvic tilt.
Measuring the intraoperative change in leg length and offset.

In unicompartmental knee arthroplasty procedures, the device assists the surgeon in:

Establishing the mechanical axis of the tibia, determining the varus/valgus angle and the posterior slope angle of the cutting block relative to the tibia, for the transverse resection.

The OrthAlign Plus® System comprises a single use computer module and reusable instrumentation.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Knee, Hip

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Surgeon

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Device performance testing confirms that the OrthAlign Plus® System can be used according to its intended use. The OrthAlign Plus® System has been verified and validated according to OrthAlign's procedures for product design and development. Performance testing addressed the new functionality and surgical procedure steps. Performance testing included:

Software verification and validation to ensure the integrity of the code and functionality and reliability of the software in various use sequences.
System hardware verification/validation testing to ensure the instruments meet their mechanical requirements.
Instrumentation cleaning, sterilization and shipping validations or adoptions for the specified processes.
System components biocompatibility assessment per ISO 10993-1 (2009).
System accuracy testing: bench testing with mechanical fixtures to verify gap distance and angle measurement accuracy.
Simulated use testing in cadaver with an advising surgeon to validate the system meets requirements for user needs and usability in a simulated use environment.

This testing regime demonstrates that the subject device is as safe, as effective, and performs as well as the predicate devices. This testing regime demonstrates that the subject device is substantially equivalent to the legally marketed predicate devices, for its intended use in the measurement of bone alignment and ligament balancing in TKA.

The information provided by OrthAlign in this 510(k) application confirms that the OrthAlign Plus® System is substantially equivalent to predicate devices such as the OrthAlign Plus® System (K171780) and Brainlab DASH Knee (K102251) and OrthoSensor VERASENSE Knee System (K150372).

A technological comparison and bench and cadaver testing demonstrate the substantial equivalence of the OrthAlign Plus® System to the predicate devices.

Key Metrics

Not Found

Predicate Device(s)

OrthAlign Plus® System (K171780), Brainlab DASH Knee (K102251), OrthoSensor VERASENSE Knee System (K150372)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 882.4560 Stereotaxic instrument.

(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).

Summary

0

November 22, 2017

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized eagle. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.

OrthAlign, Inc. David Vancelette Sr. Director QA/RA 120 Columbia, Suite 500 Aliso Viejo, California 92656

Re: K172462

Trade/Device Name: OrthAlign Plus® System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO Dated: August 11, 2017 Received: August 14, 2017

Dear David Vancelette:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

1

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Katherine D. Kavlock -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K172462

Device Name

OrthAlign Plus® System

Indications for Use (Describe)

The OrthAlign Plus® System 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. The OrthAlign Plus® System facilitates the accurate positioning of implants, relative to these alignment axes. The system aids the surgeon in controlling leg length and offset discrepancies in Total Hip Arthroplasty. Ligament balancing is provided by the OrthAlign Plus® System in primary or revision Total Knee Arthroplasty.

Example orthopedic surgical procedures include but are not limited to:

Total Knee Arthroplasty
· Total Hip Arthroplasty: Anterior/Posterior
· Unicompartmental Knee Arthroplasty: Tibial transverse resection
Ligament Balancing

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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1. 510(K) SUMMARY

This 510(k) summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92(c).

DATE	October 21, 2016
APPLICANT	OrthAlign, Inc.
120 Columbia
Suite 500
Aliso Viejo, CA 92656
Tel: (949) 715-2424
Fax: (949) 831-9500
OFFICIAL
CORRESPONDENT	David Vancelette
OrthAlign, Inc.
120 Columbia,
Suite 500
Aliso Viejo, CA 92656
dvancelette@orthalign.com
Tel: (858) 692-0335
Fax: (949) 831-9500
TRADE NAME	OrthAlign Plus® System
COMMON NAME	Stereotaxic Instrument
DEVICE
CLASSIFICATION	Class II, 21 CFR §882.4560
PRODUCT CODES	OLO: Orthopedic Stereotaxic Instrument
PREDICATE
DEVICES	OrthAlign Plus® System (K171780)
Brainlab DASH Knee (K102251)
OrthoSensor VERASENSE Knee System (K150372)
SUBMISSION TYPE	Traditional 510(k). The subject device is a modification
to the previously cleared OrthAlign Plus® System

SUBSTANTIALLY EQUIVALENT TO:

The OrthAlign Plus® System is substantially equivalent to the previously cleared OrthAlign Plus® System (K171780), Brainlab DASH Knee (K102251) and OrthoSensor VERASENSE Knee System (K150372).

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

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SECTION 5. 510(K) SUMMARY

The OrthAlign Plus® System is a non-invasive computer assisted surgical navigation system for use in knee and hip arthroplasty procedures. The OrthAlign Plus® System is configured to detect, measure, and display angular and positional measurement changes in a triaxial format. The OrthAlign Plus® System utilizes a palm-sized computer module and reference sensor to generate positional information in orthopedic procedures providing a sequence of steps for registration of anatomical landmarks, calculation of mechanical axes, and positioning of instruments relative to the mechanical axes.

In knee arthroplasty procedures, the device assists the surgeon in:

Establishing the mechanical axis of the femur, determining the varus/valgus angle and the flexion/extension angle of the cutting block relative to the femur.
. Establishing the mechanical axis of the tibia, determining the varus/valgus and the posterior slope angle of the cutting block relative to the tibia.
. Measuring the angles and gap distances between the femur and proximal tibia, for use in ligament balancing and establishing a reference line to assist in setting the rotation of the femoral implant, in primary or revision procedures.

In hip arthroplasty procedures, the device assists the surgeon in:

. Establishing the orientation of the anterior pelvic plane and determining the inclination angle and the anteversion angle of the shell impactor relative to the anterior pelvic plane, or to the anterior pelvic plane adjusted for pelvic tilt.
. Measuring the intraoperative change in leg length and offset.

In unicompartmental knee arthroplasty procedures, the device assists the surgeon in:

Establishing the mechanical axis of the tibia, determining the varus/valgus angle and ● the posterior slope angle of the cutting block relative to the tibia, for the transverse resection.
The OrthAlign Plus® System comprises a single use computer module and reusable instrumentation.

INDICATIONS FOR USE:

The OrthAlign Plus System has the same indications for use as the previously cleared OrthAlign Plus® System (K171780). Additional functionality has been added to the predicate device to provide ligament balancing and measurements of bone alignment in total knee arthroplasty. Also, Indications for Use are common to the Brainlab DASH Knee (K102251) and OrthoSensor VERASENSE Knee System (K150372). Thus, the Indications for Use are as follows:

OrthAlign Plus® System:

The OrthAlign Plus®System 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. The OrthAlign Plus® System facilitates the

5

accurate positioning of implants, relative to these alignment axes. The system aids the surgeon in controlling leg length and offset discrepancies in Total Hip Arthroplasty. Ligament balancing is provided by the OrthAlign Plus® System in primary or revision Total Knee Arthroplasty.

Example orthopedic surgical procedures include but are not limited to:

Total Knee Arthroplasty
Total Hip Arthroplasty: Anterior/Posterior ●
Unicompartmental Knee Arthroplasty: Tibial transverse resection ●
Ligament Balancing .

TECHNICAL CHARACTERISTICS (COMPARED TO PREDICATE):

The OrthAlign Plus System was cleared under K171780. The OrthAlign Plus® System comprises a single use computer module, a reusable reference sensor, a reusable laser module, a reusable femoral jig, a reusable tibial jig, a reusable posterior hip jig and a reusable anterior hip jig. The device utilizes algorithms to convert sensor outputs into spatial coordinates, providing graphical and numerical representation of instruments and anatomy on the user display screen. The OrthAlign Plus® System is being updated for total knee arthroplasty approach to include measurement of bone alignment and ligament balancing, as in the predicate device Brainlab DASH Knee (K102251), and for the application of measurement of bone alignment and ligament balancing in primary or total knee arthroplasty, as in the predicate OrthoSensor VERASENSE Knee System (K150372). All other features and principles of operation remain unchanged.

PERFORMANCE DATA:

Device performance testing confirms that the OrthAlign Plus® System can be used according to its intended use. The OrthAlign Plus® System has been verified and validated according to OrthAlign's procedures for product design and development. Performance testing addressed the new functionality and surgical procedure steps. Performance testing included:

Software verification and validation to ensure the integrity of the code and functionality and reliability of the software in various use sequences.
. System hardware verification/validation testing to ensure the instruments meet their mechanical requirements.
. Instrumentation cleaning, sterilization and shipping validations or adoptions for the specified processes.
System components biocompatibility assessment per ISO 10993-1 (2009).
. System accuracy testing: bench testing with mechanical fixtures to verify gap distance and angle measurement accuracy.
Simulated use testing in cadaver with an advising surgeon to validate the system ● meets requirements for user needs and usability in a simulated use environment.

This testing regime demonstrates that the subject device is as safe, as effective, and performs as well as the predicate devices. This testing regime demonstrates that the subject device is

6

510(K) SUMMARY

substantially equivalent to the legally marketed predicate devices, for its intended use in the measurement of bone alignment and ligament balancing in TKA.

The information provided by OrthAlign in this 510(k) application confirms that the OrthAlign Plus® System is substantially equivalent to predicate devices such as the OrthAlign Plus® System (K171780) and Brainlab DASH Knee (K102251) and OrthoSensor VERASENSE Knee System (K150372).

BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE:

A technological comparison and bench and cadaver testing demonstrate the substantial equivalence of the OrthAlign Plus® System to the predicate devices.

The subject device is identical to the predicate OrthAlign Plus® System (K171780), with the following exception: the subject device allows for the measurement of bone alignment and ligament balancing in TKA.

The table below summarizes the features of the subject device as compared to the predicate devices.

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Table 1. OrthAlign Plus® System Comparison to Predicates

| Feature or
Principle | Subject Device: OrthAlign Plus
System | Predicate OrthAlign Plus
System (K171780) | Predicate Brainlab
DASH Knee (K102251) | Predicate OrthoSensor
VERASENSE Knee
System (K150372) |
|--------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Materials | • Stainless Steel grades common
to orthopedic surgical
instruments
• Polymer grades common to
orthopedic surgical instruments
• Internal electronics | Identical | Identical | Similar:
• Polymer grades
common to orthopedic
surgical instruments
• Internal electronics |
| Control
Mechanism | Computer generation of positional
information, using inertial
sensors, microcontroller, digital
signal processor and physical
positions of registration
instruments. | Identical | Similar. Uses
stereoscopic camera,
reflective trackers and
computer to generate
positional information,
based on physical
positions of registration
instruments. | Similar:
Computer generation of
positional information
using pressure sensors
and physical position of
registration instrument. |
| Operating
Principles
Registration
of anatomy | Electronics attached to movable
instruments, placed in specified
procedural positions, on or in
contact with bony anatomy, for
recording sensor data. | Identical | Similar. Optical
registration of identical
indicated anatomic points
and instrument
orientations. | Similar:
Electronics attached to
movable instruments,
placed in specified
procedural positions, in
contact with trials or
implants, for recording
sensor data. |
| Measurement
of change in
distance | • Computer displayed values.
• Optical camera reading of
instrument position (for
distance).
• Accelerometer measurement of | Identical | Similar. Uses
stereoscopic camera,
reflective trackers and
computer to generate
positional information,
based on physical | N/A |
| Feature or
Principle | Subject Device: OrthAlign Plus
System | Predicate OrthAlign Plus
System (K171780) | Predicate Brainlab
DASH Knee (K102251) | Predicate OrthoSensor
VERASENSE Knee
System (K150372) |
| | angular change in instrument
positions. | | positions of registration
instruments. | |
| Measurement
of change in
angular
orientations | Computer displayed values
based on internal calculations. Accelerometer measurement of
angular change in instrument
positions. | Identical | Similar, with:
Computer displayed
values based on
internal calculations. Stereoscopic camera
identification of
reflective tracker
positions on
registration
instruments. | Similar, with:
Computer displayed
values based on
internal calculations. Load sensor
determination of
contact points. |
| Main System
Components | Single-use computer unit Navigation and measurement
software Reusable instrument sets | Identical | Similar: reusable
computer console instead
of single-use unit. Other
elements identical. | Similar:
Single-use electronic
unit Measurement software Reusable computer
console |
| User Interface | Integrated graphical user
interface, on an electronic unit
that attaches to instrumentation. | Identical | Similar, with the addition
of a separate computer
console with a graphical
user interface | Similar, with the addition
of a separate computer
console with a graphical
user interface |
| Energy Type | Navigation unit, reference
sensor and laser module: DC
battery power. Instruments: manual | Identical | Similar, with:
Electronic user
interface (in the
surgical field): | Identical for:
Single-use electronic
module: DC battery
power. |
| Feature or
Principle | Subject Device: OrthAlign Plus
System | Predicate OrthAlign Plus
System (K171780) | Predicate Brainlab
DASH Knee (K102251) | Predicate OrthoSensor
VERASENSE Knee
System (K150372) |
| | positioning and manipulation. | | Identical.
• Instruments: Identical
• Computer console: AC power. | |
| Sterilization | • Navigation unit: EO
sterilization.
• Instruments: autoclave
sterilization | Identical | Similar, with:
• Electronic user
interface (in the
surgical field): sterile
draping.
• Instruments: Identical | Identical for:
• Single-use electronic
module: EO
sterilization. |
| Biocompatibility | Per ISO 10993-1, External
Communicating Device,
Tissue/Bone/Dentin
Communicating, with subsystems
that have direct and potential
indirect contact for a limited
contact duration (