Non-inflammatory degenerative joint disease including post-traumatic arthritis and osteoarthritis.
Failed previous implant.
Correctable deformity.
All TGS® UKA System implants are intended for cemented use only.
Components of this system are designed for single use and to be used as a system.

Device Description

The TGS® UKA System is composed of unicompartmental femoral components and unicompartmental tibial components. These components may be used in various combinations to create a single unicompartmental femorotibial replacement for either the medial or lateral side of the knee. TGS® UK A System components include individually packaged femoral components made of cobalt-chromium allov and all-poly tibial components of ultra-high molecular weight polyethylene with radiographic markers. The femoral components are available in 6 symmetrical sizes for medial or lateral application in right or left knees. The tibial components are available in two sets of 6 sizes; one set for right-medial or leftlateral tibial plateau, and one set for right-lateral or left-medial tibial plateau. Each tibial component size is available in 5 thicknesses with cither flat or contoured articular surface, and with either two contoured pegs or anterior-posterior (A/P) keel cement/bone fixation features.

AI/ML Overview

The provided text is a 510(k) summary for the TGS® Unicompartmental Knee Arthroplasty System (TGS® UKA System). This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through clinical studies of the device itself.

Therefore, many of the requested categories about acceptance criteria, device performance, and study details are not applicable or not provided in this type of submission.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not specified in this document for the TGS® UKA System. The submission relies on substantial equivalence to predicate devices, implying performance similar to those devices.	Not specified in this document for the TGS® UKA System. Performance is inferred to be similar to legally marketed predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

Sample size for the test set: Not applicable. No clinical "test set" was used for the TGS® UKA System to prove performance directly. The submission relies on non-clinical testing and substantial equivalence to predicates.
Data provenance: Not applicable.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. No ground truth establishment by experts was needed for the TGS® UKA System as no clinical study to demonstrate performance against specific criteria was performed.

4. Adjudication Method for the Test Set

Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was an MRMC study done? No.
Effect size: Not applicable.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This is a medical device (knee implant), not an algorithm or AI.

7. Type of Ground Truth Used

Not applicable.

8. Sample Size for the Training Set

Not applicable, as this is not an AI/ML device and no "training set" was used in the context of this submission. The "training" for substantial equivalence comes from the existing knowledge and performance of the predicate devices.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary of Device Acceptance and Study as per K090024:

Acceptance Criteria for Regulatory Approval: The primary acceptance criterion for the TGS® UKA System in this 510(k) submission was to demonstrate substantial equivalence to legally marketed predicate devices (K010810 DePuy Orthopaedics Preservation Unicondylar Knee Prosthesis and K012591 Wright Medical Technology ADVANCE® Unicondylar Knee System).
Study Proving Acceptance:
- The submission states, "The safety and effectiveness of TGS® UKA System are adequately supported by the substantial equivalence information, materials data, and testing results provided within this premarket notification."
- Non-Clinical Testing: "Engineering analysis was performed to demonstrate that the TGS® UKA System implant components presented no new risks and are substantially equivalent to the predicate devices." This likely included mechanical testing, material characterization, and design comparisons. Specific tests (e.g., fatigue, wear) are implied but not detailed in this summary.
- Clinical Testing: "Clinical testing was not necessary to demonstrate substantial equivalence between the subject TGS® UKA System implant components and the predicate devices." This is a key statement indicating the reliance on non-clinical data and comparison to predicates.

In essence, the "study" proving the device met "acceptance criteria" here was a comprehensive comparison of its indications for use, principles of operation, materials, sizes, type of interface, fixation, packaging, and sterility to two already cleared predicate devices, along with engineering analysis, to establish substantial equivalence.

Summary

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K090024

2 510(k) Summary

Date Prepared: January 2, 2009

Submitter's Name / Contact Person

Manufacturer

Alexandria Research Technologics, LLC 13755 First Ave. North, Suite 100 Plymouth, Minnesota 55441

Contact Person

Mike Renner Vice President Operations Office : 952-949-2235 Fax : 952-949-2007 Email : miker@art-orthopaedics.com

General Information

Proprietary Name	TGS® Unicompartmental Knee Arthroplasty System (TGS® UKASystem)
Common Name	Compartmental Knee Prosthesis System
Classification Name	CFR 21 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis, Class II
Classification Name	CFR 21 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis, Class II
Product Device Code	HSX, HRY
Predicate Devices	K010810 DePuy Orthopaedics Preservation Unicondylar KneeProsthesis
Predicate Devices	K012591 Wright Medical Technology ADVANCE® UnicondylarKnee System

Device Description

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K090024 *2/2

Indications for Use

The TGS Unicompartmental Knee Arthroplasty System is intended for arthroplasty of either condyle of a knee with the following indications:

1. Non-inflammatory degenerative joint disease including post-traumatic arthritis and osteoarthritis.
1. Failed previous implant.
1. Correctable deformity.
1. All TGS® UKA System implants are intended for cemented use only.

Components of this system are designed for single use and to be used as a system.

Substantial Equivalence Discussion

The indications for use, principles of operation, materials, sizes, type of interface, fixation, packaging, and sterility of the TGS® UKA System components are substantially equivalent to the predicate devices previously cleared for market. The safety and effectiveness of TGS® UKA System are adequately supported by the substantial equivalence information, materials data, and testing results provided within this premarket notification.

Non-Clinical Testing

Engineering analysis was performed to demonstrate that the TGS® UKA System implant components presented no new risks and are substantially equivalent to the predicate devices.

Clinical Testing

Clinical testing was not necessary to demonstrate substantial equivalence between the subject TGS® UKA System implant components and the predicate devices.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circle around the eagle. The eagle is depicted in black, and the text is also in black.

Public Health Service

MAY - 4 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Alexandria Research Technologies, LLC % Mr. Michael Renner 13755 First Avenue North, Suite 100 Plymouth, Minnesota 55441

Re: K090024

Trade/Device Name: TGS Unicompartmental Knee Arthroplasty Regulation Number: 21 CFR 888.3520 Regulation Name: Knee joint femorotibial metal/polymer non-constrained cemented prosthesis Regulatory Class: II Product Code: HSX, HRY Dated: April 16, 2009 Received: April 17, 2009

Dear Mr. Renner:

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.

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 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.

{3}------------------------------------------------

Page 2 - Mr. Michael Renner

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/indcx.html.

Sincerely yours,

Barbarabonehms

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

Enclosure

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Indications for Use

510(k) Number (if known): K050024

Device Name: TGS® Unicompartmental Knee Arthroplasty System

Indications for Use:

The TGS Unicompartmental Knee Arthroplasty System is intended for arthroplasty of a knee with the following indications:

Non-inflammatory degenerative joint disease including post-traumatic arthritis and osteoarthritis. l.
1. Failed previous implant.
Correctable deformity 3.
All TGS® UKA System implants are intended for cemented use only. 4.

Components of this system are designed for single use and to be used as a system.

Prescription Use XX (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

· (Posted November 13, 2003)

Smita

(Division Sign. Off)

્દ્રિ . . .

icion Sional Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K090024

Regulation Number and Section

§ 888.3520 Knee joint femorotibial metal/polymer non-constrained cemented prosthesis.

(a)
Identification. A knee joint femorotibial metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral condylar resurfacing component or components made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components made of ultra-high molecular weight polyethylene and are intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.