The Molded Metal-back Tibial components are intended to replace the patient's proximal tibia during primary or revision total knee arthroplasty. This device has been designed to substitute for the posterior stability of the Posterior Cruciate Ligament (PCL) and is intended for cemented application.

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

In materials and design, the proposed Molded Metal-back Tibial components are a combination of:

The articulating surfaces of the Exactech Optetrak Tibial Tray Insert components (K933610 and K011976)
The tibial stem of the Cemented Finned Tibial Tray components (K932776 and K011976).

The device modifications presented in this Special 510(k) represent changes to the posterior stabilized, modular tibial insert and finned tibial tray components of the Optetrak Total Knee (K932776, K933610 and K011976). No changes were made to the femoral or patellar components of this system.

The proposed device modifications involve:

Modification to the portion of the modular assembly distal to the proximal articulating surface and proximal to the distal finned stem.
Revised cement fixation undercuts on the distal portion of the component
Integration of geometric undercuts to form a mechanical interlock between the UHMWPE and metallic portions of the component
A change in material of the finned stem portion from titanium alloy to cobaltchromium (CoCr)

No modifications have been made to the articular surface of the UHMWPE that interfaces with the femoral components. Nor have any configuration changes been made to the finned stem portion of the tibial bone interface.

There have been no changes to the material of the predicate Optetrak Total Knee bearing surface. Like the predicate Optetrak Total Knee tibial inserts, the proposed bearing surface is manufactured of Ultra-High Molecular Weight Polyethylene (UHMWPE) conforming to ASTM F648.

AI/ML Overview

This document describes a Special 510(k) submission for a line extension to the Exactech Optetrak Total Knee System, specifically for "Molded Metal-back Tibial Components." The application focuses on demonstrating substantial equivalence to previously cleared predicate devices through design modifications and performance testing.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Test Description	Reported Device Performance
Functional Performance	Adequate for anticipated in vivo loading conditions.	"Functional testing was conducted to verify that the implant performance would be adequate for anticipated in vivo loading." The conclusion drawn is that "the Molded Metal-back Tibial Components are substantially equivalent to other devices legally marketed in the United States, most notably Exactech's predicate Optetrak products." This implies the device met the functional performance expectations set by the predicate devices.
Material Equivalence	The articulating surfaces of the Exactech Optetrak Tibial Tray Insert components (K933610 and K011976) and the tibial stem of the Cemented Finned Tibial Tray components (K932776 and K011976) were used as references for the proposed design. Material for the bearing surface should be Ultra-High Molecular Weight Polyethylene (UHMWPE) conforming to ASTM F648.	The proposed device modifications combine the articulating surfaces of K933610 and K011976 and the tibial stem of K932776 and K011976. The finned stem portion was changed from titanium alloy to cobalt-chromium (CoCr). No changes were made to the articular surface of the UHMWPE. The proposed bearing surface is manufactured of UHMWPE conforming to ASTM F648, "Like the predicate Optetrak Total Knee tibial inserts." This suggests meeting the material criteria by either maintaining or establishing equivalence to the predicate.
Design Equivalence (Modifications)	Modifications should not negatively impact safety and effectiveness compared to predicate devices. The modifications include changes to the modular assembly, revised cement fixation undercuts, integration of geometric undercuts for mechanical interlock, and a material change for the finned stem.	Explicitly stated modifications are: 1) Modification to the portion of the modular assembly distal to the proximal articulating surface and proximal to the distal finned stem. 2) Revised cement fixation undercuts on the distal portion of the component. 3) Integration of geometric undercuts to form a mechanical interlock between the UHMWPE and metallic portions of the component. 4) A change in material of the finned stem portion from titanium alloy to cobalt-chromium (CoCr). The unchanged aspects include the articular surface of the UHMWPE and the configuration of the finned stem's bone interface. These changes were deemed acceptable through the comparative analysis and functional testing.

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

The document does not specify a sample size for any "test set" in the context of clinical testing with human subjects or a defined dataset for AI/algorithm performance. The evaluation is primarily based on functional testing of the implant, design comparisons to predicate devices, and material specifications.

The data provenance is prospective functional testing conducted by the manufacturer, Exactech, Inc. There is no indication of retrospective or prospective clinical human data, nor is there any mention of country of origin for such data.

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

This information is not applicable and not provided in the document. The evaluation is focused on the mechanical and material properties of a prosthetic device, not on interpreting images or making diagnoses that would require expert-established ground truth.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods are typically used in clinical studies or for establishing ground truth for AI algorithms, which are not described here.

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

This information is not applicable and not provided. This document pertains to a knee prosthesis and does not involve AI or human "readers" of medical images or data.

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

This information is not applicable and not provided. This document describes a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device appears to be based on:

Validated engineering principles and functional testing standards: The performance data summary mentions "Functional testing was conducted to verify that the implant performance would be adequate for anticipated in vivo loading." This implies comparison against established biomechanical standards and expected performance in the human body.
Material specifications: Conformance to ASTM F648 for UHMWPE.
Design characteristics of legally marketed predicate devices: The primary method of showing substantial equivalence is by demonstrating that the new device's design, materials, and functional performance are similar to or equivalent to existing, cleared devices (K933610, K011976, K932776).

There is no mention of expert consensus, pathology, or outcomes data as a ground truth for the technical evaluation presented in this 510(k) summary.

8. The Sample Size for the Training Set

This information is not applicable and not provided. There is no mention of a "training set" as this is not an AI/machine learning device.

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

This information is not applicable and not provided. As there is no training set mentioned, this question is irrelevant to the provided document.

Summary

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

K030686 page '14'

Exactech® Optetrak® Total Knee System Line Extension -- Molded Metal-back Tibial Component Special 510(k)

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

APR 0 2 2003 Summary of Safety and Effectiveness

APR 02 2003

Classification Name:	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Trade/Proprietary Model Names:	Optetrak Total Knee SystemMolded Metal-back Tibial Component
Product Code:	JWH
C.F.R. Section:	888.3560
Device Class:	II
Classification Panel:	Orthopedic

Legally Marketed Devices for Substantial Equivalence Comparison:

Model	Manufacturer	510(k)#
Optetrak® Total Knee – Posterior Stabilized TibialTray Insert Components	Exactech	K933610
Exactech Cruciate Retaining Cemented TibialComponents – Cemented Finned Tibial TrayComponents	Exactech	K932776
Optetrak® Total Knee System: Size 0/1 Delta LineExtension – Cemented Finned Tibial Tray Componentsand Posterior Stabilized Tibial Inserts	Exactech	K011976
AGC Total Knee Prosthesis - Posterior-StabilizedTibial Components	Biomet	K833921
Insall/Burstein Constrained Total Condylar Knee	Zimmer	K810520

In materials and design, the proposed Molded Metal-back Tibial components are a combination of:

The articulating surfaces of the Exactech Optetrak Tibial Tray Insert components (K933610 and K011976)
The tibial stem of the Cemented Finned Tibial Tray components (K932776 and K011976).

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

Page 13

Exactech® Optetrak® Total Knee System Line Extension – Molded Metal-back Tibial Component Special 510(k)

Summary of Safety and Effectiveness

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

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

Section 4 Page Sof

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

page 3 of 3

Exactech® Optetrak® Total Knee System Line Extension - Molded Metal-back Tibial Component Special 510(k)

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

The proposed device modifications involve:

Modification to the portion of the modular assembly distal to the proximal articulating surface and proximal to the distal finned stem.
Revised cement fixation undercuts on the distal portion of the component
Integration of geometric undercuts to form a mechanical interlock between the UHMWPE and metallic portions of the component
A change in material of the finned stem portion from titanium alloy to cobaltchromium (CoCr)

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 Molded Metal-back Tibial Components are substantially equivalent to other devices legally marketed in the United States, most notably Exactech's predicate Optetrak products.

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

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 0 2 2003

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

Re: K030686

Trade/Device Name: Optetrak® Total Knee System - Molded Metal Back Tibial Component Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: February 28, 2003 Received: March 5, 2003

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.

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

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), 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) you may obtain. 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/dsmarnain.html

Sincerely yours,

Mark A. Millman

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative

and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Exactech® Optetrak® Total Knee System Line Extension - Molded Metal-back Tibial Component Special 510(k)

Indications for Use

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

510(k) Number:

4030686

Device Name:

Molded Metal-back Tibial Component

INDICATIONS

CONTRAINDICATIONS

CAUTION: In the USA, for cemented use only.

Mark N Milkman

Division Sion-Off) Division of General, Restorative and Neurological Devices

X030686 510(k) Number_

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.