K Number

Device Name

ORTHOALIGN PLUS SYSTEM

Manufacturer

ORTHALIGN, INC

Date Cleared

2013-11-08

(266 days)

Product Code

OLO

Regulation Number

882.4560

Intended 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. Example orthopedic surgical procedures include but are not limited to: - Total Knee Arthroplasty o - Total Hip Arthroplasty: Anterior / Posterior . The KneeAlign® 3 System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrument and structures during stereotactic orthopedic surgical procedures. The KneeAlign® 3 System facilitates the accurate positioning of implants, relative to these alignment axes. Example orthopedic surgical procedures include but are not limited to: - · Total Knee Arthroplasty The HipAlign 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 HipAlign® System facilitates the accurate positioning of implants, relative to these alignment axes. Example orthopedic surgical procedures include but are not limited to: - · Total Hip Arthroplasty: Anterior / Posterior

Device Description

The OrthAlign Plus" System is an innovative 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 femur. - Establishing the mechanical axis of the tibia, determining the varus/valgus angle . and the posterior slope angle of the cutting block relative to tibia. 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. The OrthAlign Plus™ System comprises a single use computer module and reusable instrumentation. The OrthAlign Plus™ System is usable for a total knee arthroplasty or total hip arthroplasty procedure. The System includes two optional configurations: the KneeAlign® 3 System usable for total knee arthroplasty only, and the HipAlign® System usable for total hip arthroplasty only. The OrthAlign Plus" System includes the singleuse OrthAlign Plus™ Unit, a KneeAlign® 3 Instrument Set and a HipAlign® Instrument Set. The optional configurations include a modified version of the OrthAlign Plus" Unit and only one of the Instrument Sets. Indications for Use for each optional configuration are limited to the applicable orthopedic procedure. The OrthAlign Plus" System comprises a single use computer module, a reusable reference sensor, 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 optional KneeAlign® 3 and HipAlign® system configurations also comprise the single use computer module, reusable reference sensor and applicable reusable jigs. They utilize the same algorithms, sensor conversions, graphical and numerical representations and surgical techniques as the OrthAlign Plus™ System.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K103829, K043536, K041369

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description mentions "algorithms" for converting sensor outputs to spatial coordinates and providing graphical/numerical representations, but there is no mention of AI, ML, deep learning, or any related concepts. The performance studies focus on traditional validation methods like bench testing, cadaver studies, and virtual testing, without any indication of training or testing AI/ML models.

Therapeutic

No
The device is described as assisting surgeons in determining reference alignment axes and positioning implants during surgery; it primarily provides guidance and measurement, rather than directly treating a condition or restoring function itself.

Diagnostic

Explanation: The device is described as a computer-controlled system intended to "assist the surgeon in determining reference alignment axes" and "facilitates the accurate positioning of implants." This indicates it is a surgical navigation or assistance system, providing guidance and measurements during a procedure rather than diagnosing a condition.

SaMD (Software as a Medical Device)

The device description explicitly states that the system comprises a "palm-sized computer module and reference sensor" and "reusable instrumentation" (jigs). It also mentions "System hardware verification and validation testing" in the performance studies summary. This indicates the device includes significant hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device 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 surgical navigation and guidance system used during a surgical procedure, not a test performed in vitro (outside the body) on biological specimens to diagnose or monitor a condition.
Device Description: The description details a "computer assisted surgical navigation system" that "detects, measures, and displays angular and positional measurement changes." This aligns with the function of a surgical guidance system, not an IVD.
Anatomical Site: The device is used on the "Knee, Hip," which are anatomical sites within the body during surgery. IVDs typically analyze samples taken from the body (blood, urine, tissue, etc.).
Intended User / Care Setting: The intended user is a "Surgeon" in an "operating room environment," which is consistent with a surgical device.
Performance Studies: The performance studies described involve "cadaver and virtual testing," "bench testing with mechanical fixtures and foam models," and "radiographic evaluation." These are typical validation methods for surgical devices, not IVDs which would involve clinical studies analyzing test results against a reference standard.

In summary, the OrthAlign Plus™ System and its configurations are surgical navigation and guidance systems used during orthopedic procedures to assist the surgeon with implant placement. They do not perform tests on biological samples outside the body for diagnostic purposes, which is the defining characteristic of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The KneeAlign® 3 System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrument and structures during stereotactic orthopedic surgical procedures. The KneeAlign® 3 System facilitates the accurate positioning of implants, relative to these alignment axes. Example orthopedic surgical procedures include but are not limited to: Total Knee Arthroplasty.

The HipAlign® 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 HipAlign® System facilitates the accurate positioning of implants, relative to these alignment axes. Example orthopedic surgical procedures include but are not limited to: Total Hip Arthroplasty: Anterior / Posterior.

Product codes (comma separated list FDA assigned to the subject device)

OLO

Device Description

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

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.

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

The OrthAlign Plus™ System is usable for a total knee arthroplasty or total hip arthroplasty procedure. The System includes two optional configurations: the KneeAlign® 3 System usable for total knee arthroplasty only, and the HipAlign® System usable for total hip arthroplasty only. The OrthAlign Plus" System includes the singleuse OrthAlign Plus™ Unit, a KneeAlign® 3 Instrument Set and a HipAlign® Instrument Set. The optional configurations include a modified version of the OrthAlign Plus" Unit and only one of the Instrument Sets. Indications for Use for each optional configuration are limited to the applicable orthopedic procedure.

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, Operating Room

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

For simulated use testing, a prospective cadaver validation was done with a series of 3 labs in a simulated operating room environment with 3 surgeons conducting the procedures, both anterior and posterior approaches. A follow-up virtual study was conducted on the system's navigation in the posterior approach with software updates applied to the earlier testing.

Navigation of cup angles in the anterior approach was validated in a series of 2 cadaver labs with 30 specimens (30 hips), using radiographic evaluation of the cup placements.

Navigation of cup angles in the posterior approach was validated in a series of 2 cadaver labs with 12 full body specimens (18 hips), using radiographic evaluation of cup placements and a follow-up virtual study of navigation with software updates applied.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 included:

Software verification and validation
System hardware verification and validation testing
Electrical safety and electromagnetic compatibility testing
Instrumentation cleaning, sterilization and shipping validations
System components biocompatibility assessment
Customer requirements validation
System accuracy testing: bench testing with mechanical fixtures and foam models
Simulated use testing: cadaver and virtual testing

This testing regime demonstrates that the subject device is substantially equivalent to the legally marketed predicate devices, for its intended use in facilitating the accurate positioning of implants and instrumentation, relative to reference alignment axes.

The information provided by OrthAlign in this 510(k) application confirms that the OrthAlign Plus™ System is substantially equivalent to predicate devices: KneeAlign® 2 System (K103829), Navitrack System- S&N Image Free Knee (K043536) and Navitrack System- S&N Image Free Hip (K041369).

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

KneeAlign® 2 System (K103829), Navitrack System - S&N Image Free Knee (K043536), Navitrack System - S&N Image Free Hip (K041369)

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

K130387

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).

| APPLICANT | OrthAlign, Inc.
120 Columbia
Suite 500
Aliso Viejo, CA 92656
Tel: (949) 715-2424
Fax: (949) 831-9500 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| OFFICIAL
CORRESPONDENT | Amy Walters
AWE, Inc.
338 Vista Madera
Newport Beach, CA 92660
amylynnwalters@gmail.com
Tel: (949) 923-9400
Fax: (949) 831-9500 |
| | NOV 0 8 2013 |
| 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 | KneeAlign® 2 System (K103829)
Navitrack System - S&N Image Free Knee (K043536)
Navitrack System - S&N Image Free Hip (K041369) |
| SUBMISSION TYPE | Traditional 510(k). The subject device is a modification
to the previously cleared KneeAlign® 2 System
(K103829). |

SUBSTANTIALLY EQUIVALENT TO:

The OrthAlign Plus" System is substantially equivalent to the previously cleared KneeAlign® 2 System (K103829), Navitrack System - S&N Image Free Hip (K041369) and Navitrack System- S&N Image Free Knee (K043536).

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

The current standard of care for knee arthroplasty procedures has the physician estimating these changes either by visual observation and mechanical guides with tactile feedback or with assistance of computer assisted surgery devices.

The current standard of care for hip arthroplasty procedures has the physician estimating angular orientation of the acetabular shell either by visual observation and mechanical guides or with assistance of computer assisted surgery devices.

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

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.
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 KneeAlign® 2 System (K 103829). Additional functionality has been added to the predicate device to enable navigation for Total Hip Arthroplasty. Also, Indications for Use are common to the Navitrack System- S&N Image Free Hip (K041369) and Navitrack System- S&N Image Free Knee (K043536). 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 accurate positioning of implants, relative to these alignment axes.

Example orthopedic surgical procedures include but are not limited to:

Total Knee Arthroplasty o
Total Hip Arthroplasty: Anterior / Posterior .

KneeAlign® 3 System:

The KneeAlign® 3 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 KneeAlign® System facilitates the accurate positioning of implants, relative to these alignment axes.

Example orthopedic surgical procedures include but are not limited to:

· Total Knee Arthroplasty

HipAlign® System:

The HipAlign 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 HipAlign® System facilitates the accurate positioning of implants, relative to these alignment axes.

Example orthopedic surgical procedures include but are not limited to:

· Total Hip Arthroplasty: Anterior / Posterior

TECHNICAL CHARACTERISTICS:

The OrthAlign Plus" System comprises a single use computer module, a reusable reference sensor, 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 optional KneeAlign® 3 and HipAlign® system configurations also comprise the single use computer module, reusable reference sensor and applicable reusable jigs. They utilize the same algorithms, sensor conversions, graphical and numerical representations and surgical techniques as the OrthAlign Plus™ System.

The terms "OrthAlign Plus" System" and "OrthAlign Plus™ Unit" are used henceforth in this submission to refer to all three system configurations and all three single-use computer modules, except where all three configurations are cited and differentiated.

PERFORMANCE DATA:

Software verification and validation ●
System hardware verification and validation testing ●
Electrical safety and electromagnetic compatibility testing .
Instrumentation cleaning, sterilization and shipping validations ●
System components biocompatibility assessment �
Customer requirements validation ●
System accuracy testing: bench testing with mechanical fixtures and foam models .
. Simulated use testing: cadaver and virtual testing

Navigation of cup angles in the anterior approach was validated in a series of 2 cadaver labs with 30 specimens (30 hips), using radiographic evaluation of the cup placements.

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.

Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the perimeter. Inside the circle is a stylized symbol that resembles a person with outstretched arms.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 8, 2013

OrthAlign, Incorporated % Ms. Amy Walters A WE, Incorporated 338 Vista Madera Newport Beach, California 92660

Re: K130387

Trade/Device Name: OrthAlign Plus" System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: September 25, 2013 Received: October 1, 2013

Dear Ms. Walters:

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, listing 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

Page 2 - Ms. Amy Walters

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/defay.lt,htm_for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson -S

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

Enclosure

2. INDICATIONS FOR USE STATEMENT

2.1. ORTHALIGN PLUS™ SYSTEM

510(k) Number (if known): K130387

Device Name: OrthAlign Plus™ System

Indications for Use:

Example orthopedic surgical procedures include but are not limited to:

Total Knee Arthroplasty .
Total Hip Arthroplasty: Anterior / Posterior .

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Long H. Chen -A

9 2342,19200300 100,1.1 = 13003690

Page 1 of 3

for MXM

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K130387

Response to Questions K130387

2.2. KNEEALIGN® 3 SYSTEM

510(k) Number (if known): K130387

Device Name: KneeAlign® 3 System

Indications for Use:

Example orthopedic surgical procedures include but are not limited to:

Total Knee Arthroplasty ●
Prescription Use x (Part 21 CFR 801 Subpart D)

AND/OR

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

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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 2 of _ 3

Lona H. Chen -A

igitally signed by Lang H. Chen-A
c=US, o=U.S. Government, ou=HHS,
OU=FDA, ou=People, cn=Long H. Chen-A,
1.2.342.19200300 100 1.1-1300369056
Date 2013.11.08 11:12:55 -05:00

for MXM

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K130387

2.3. HIPALIGN® SYSTEM

510(k) Number (if known): K130387

Device Name: HipAlign® System

Indications for Use:

Example orthopedic surgical procedures include but are not limited to:

Total Hip Arthroplasty: Anterior / Posterior .
Prescription Use x (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 3 of 3

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.-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------

gitally signed by Long H. Chen-A
*CUS. DUS. Govemment, ouOHMS
FDA, ou People, cn-Long H. Chen-A
0.2342.19200300.100.1.1-1300369056
te: 2013.11.08 11:13:15-0500

for

for MXM

(Division Sign-Off) Division of Surgical Devices S10(k) Number: K130387