The Offset Tibial Tray components are intended to replace the patient's proximal tibia during primary or revision total knee arthroplasty. The Optetrak Offset Tibial Tray is intended for use when the tibial intramedullary (IM) canal is offset from the tibial plateau.

The OPTETRAK® Total Knee Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.

Device Description

The device modifications presented in this Special 510(k) represent changes to the Tibial Tray Components of the Optetrak Total Knee System (premarket notifications #K933610 and #K011976). No changes were made to the other components of the Optetrak Total Knee System.

The proposed device modifications involve offsetting the distal portion of the tray's stem in the sizes 0, 1 Delta, 1, 2, 3, 4 and 5. This is done in order to accommodate varying patient anatomies.

No modifications have been made to the mating features of the Tibial Tray in order to maintain the full mating capabilities with all tibial inserts, augmentation components and stem extensions of the predicate Optetrak Total Knee System

The proposed offset design incorporates modified screws for attachment of the Constrained Condylar Tibial Inserts and the Tibial Stem Extensions.

There have been no changes to the material of the predicate Optetrak Tibial Tray components. Like the predicate Optetrak Tibial Tray components (#K933610 & #K011976), the proposed tray components are manufactured from titanium alloy (Ti 6 Al 4V) conforming to ASTM F-136.

AI/ML Overview

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance for the Exactech® Optetrak® Total Knee System Line Extension - Offset Tibial Tray Special 510(k)

This document describes a Special 510(k) submission for modifications to an existing device, the Optetrak Total Knee System. The primary modification involves offsetting the distal portion of the tibial tray's stem. For such submissions, the acceptance criteria are typically met by demonstrating that the modified device is substantially equivalent to the predicate device and that the modifications do not negatively impact its safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicit for a Special 510(k) device modification)	Reported Device Performance
Functional Performance	The modified components (Offset Tibial Tray) must perform adequately under anticipated in vivo loading conditions, equivalent to the predicate device.	"Functional testing was conducted to verify that the implant performance would be adequate for anticipated in vivo loading."
Material Equivalence	The material of the modified components must be the same as, or demonstrably equivalent to, the predicate device.	"There have been no changes to the material of the predicate Optetrak Tibial Tray components. Like the predicate Optetrak Tibial Tray components (#K933610 & #K011976), the proposed tray components are manufactured from titanium alloy (Ti 6 Al 4V) conforming to ASTM F-136."
Mating Feature Compatibility	The modified components must maintain full compatibility with existing components of the predicate system (tibial inserts, augmentation components, stem extensions).	"No modifications have been made to the mating features of the Tibial Tray in order to maintain the full mating capabilities with all tibial inserts, augmentation components and stem extensions of the predicate Optetrak Total Knee System."
Intended Use & Indications	The modified device's intended use and indications must remain consistent with the predicate device, with the modification accommodating specific anatomical variations.	The Intended Use explicitly states the Offset Tibial Tray is "intended for use when the tibial intramedullary (IM) canal is offset from the tibial plateau." The Indications are identical to the predicate device.
Overall Safety & Effectiveness	The modified device must be considered safe and effective, and substantially equivalent to legally marketed predicate devices.	"We conclude that the Optetrak Offset Tibial components are substantially equivalent to other devices legally marketed in the United States, most notably Exactech's predicate Optetrak products." (FDA's letter of October 17, 2002, also affirms substantial equivalence).

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

The provided text does not specify a sample size for a test set in the context of clinical data for the Offset Tibial Tray. This is because the submission is a Special 510(k) for a device modification, relying heavily on predicate device equivalence and bench testing rather than new clinical trials.

The data provenance for the "Functional testing" is not explicitly stated (e.g., country of origin, retrospective or prospective), but it would be laboratory-based (bench testing), not clinical.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable or provided in the context of this Special 510(k) submission. The "ground truth" here is established through mechanical testing standards and comparison to the predicate device's performance, not by expert review of patient data.

4. Adjudication Method for the Test Set

This information is not applicable or provided. Since the primary performance data comes from functional (bench) testing, there would be no need for an adjudication method as typically applied to expert-reviewed clinical or imaging data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There was no MRMC comparative effectiveness study done, as this is a mechanical medical device (a knee implant), not an AI-powered diagnostic tool. The concept of "human readers" and "AI assistance" is not relevant to this device.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable or provided. This device is a mechanical implant, not an algorithm, so a "standalone algorithm" performance assessment is irrelevant.

7. The Type of Ground Truth Used

For this Special 510(k) submission concerning a mechanical device modification, the "ground truth" for demonstrating safety and effectiveness is primarily based on:

Mechanical performance standards and established engineering principles: Ensuring the modified implant can withstand anticipated in vivo loads.
Material specifications: Conformance to ASTM standards (ASTM F-136 for Ti 6 Al 4V).
Demonstrated performance of the predicate device: The new design is compared to the known and accepted performance of the legally marketed predicate Optetrak products.

Thus, the ground truth is derived from bench testing results and material compliance, not pathology, patient outcomes, or expert consensus on clinical data for the modified component itself.

8. The Sample Size for the Training Set

This information is not applicable or provided. As this is a mechanical medical device, there is no "training set" in the context of machine learning or AI. The design and testing are based on engineering principles and predicate device data.

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

This information is not applicable or provided for the same reasons as in point 8.

Summary

{0}------------------------------------------------

K033186 pg 142

Exactech® Optetrak® Total Knee System Line Extension - Offset Tibial Tray Special 510(k)

Summary of Safety and Effectiveness

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Device Information:

INTENDED USE

INDICATIONS

CONTRAINDICATIONS

The OPTETRAK® Total Knee Systems are contraindicated in patients with active infection, patients without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis, patients without sufficient soft tissue integrity to provide adequate stability, and in patients with either mental or neuromuscular disorders that do not allow control of the knee joint, and in patients whose weight, age, or activity level might cause extreme loads and early failure of the system.

CAUTION: In the USA, for cemented use only.

Device Modifications

The proposed device modifications involve offsetting the distal portion of the tray's stem in the sizes 0, 1 Delta, 1, 2, 3, 4 and 5. This is done in order to accommodate varying patient anatomies.

{1}------------------------------------------------

page of

Exactech® Optetrak® Total Knee System Line Extension - Offset Tibial Tray Special 510(k)

Summary of Safety and Effectiveness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

The proposed offset design incorporates modified screws for attachment of the Constrained Condylar Tibial Inserts and the Tibial Stem Extensions.

PERFORMANCE DATA SUMMARY

Functional testing was conducted to verify that the implant performance would be adequate for anticipated in vivo loading.

We conclude that the Optetrak Offset Tibial components are substantially equivalent to other devices legally marketed in the United States, most notably Exactech's predicate Optetrak products.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles a stylized human figure or a bird in flight. The symbol is composed of curved lines and shapes, creating a sense of movement and dynamism.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 7 2002

Mr. Martin Sprunck Regulatory Representative Exactech, Inc. . 2320 NW 66" Court Gainesville, Florida 32653

Re: K023186

Trade/Device Name: OPTETRAK® Total Knee System Offset Tibial Tray Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer/Metal/Polymer Semi-constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH Dated: September 19, 2002 Received: September 24, 2002

Dear Mr. Sprunck :

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 such 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); good manufacturing practice requirements as set 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.

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

Page 2 - Mr. Martin Sprunck

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Sincerly, yours,

O. Mark N. Melleuson

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Exactech® Optetrak® Total Knee System Line Extension - Offset Tibial Tray Special 510(k)

Indications for Use : . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

510(k) Number:

KO23186

Device Name:

Offset Tibial Tray

INDICATIONS

CONTRAINDICATIONS

CAUTION: In the USA, for cemented use only.

Mark A. Milburn

Division of General, Restorative and Neurological Devices

510(k) Number K023186

Please do not write below this line - use another page if needed.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over the Counter Use No

Section 3 Page 1 of 1

Regulation Number and Section

§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.