The ADVANCE® 913 Medial Pivot Tibial Insert and the ADVANCE® 913 Medial Pivot Tibial Base are indicated for use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions:

noninflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascular necrosis
inflammatory degenerative joint disease including rheumatoid arthritis:
correction of functional deformity;
revision procedures where other treatments or devices have failed: and
treatment of fractures that are unmanageable using other techniques.
ADVANCE® 913 Medial Pivot Tibial Base and Insert Components are for use with bone cement.

Device Description

Tibial Insert:

Manufactured from UHMWPE conforming to ASTM F648 .
Sizes: 1-5 Left & Right .
Thickness: 10, 12, 14, 17 mm .
Tibial Base:
Manufactured from Cobalt Chrome alloy conforming to ASTM F75 .
Sizes: 1-5 plus .
Symmetrical .
No screw holes .

AI/ML Overview

This document is a 510(k) summary for the ADVANCE® 913 Medial Pivot Tibial Insert and Base, which are components of a knee arthroplasty system. It's a regulatory submission to the FDA demonstrating substantial equivalence to previously cleared devices, not a study describing device performance against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics is not present in this document.

Here's what can be extracted based on the provided text, and what cannot:

1. A table of acceptance criteria and the reported device performance

Cannot be provided. This document does not specify quantitative acceptance criteria or report specific performance metrics for the device. It is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against predefined acceptance criteria through clinical or standalone studies.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be provided. The document does not describe a test set or any specific study that would involve a sample size of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Cannot be provided. There is no mention of a test set, ground truth, or experts in this document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Cannot be provided. No test set or adjudication method is described.

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

Cannot be provided. This document is for a medical implant (tibial insert and base), not an AI-assisted diagnostic device. Therefore, an MRMC study involving human readers and AI assistance is not applicable and not mentioned.

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

Cannot be provided. This is not a software/algorithm device, so a standalone algorithm performance evaluation is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Cannot be provided. As no study creating a new ground truth is described, this information is not available.

8. The sample size for the training set

Cannot be provided. This document does not describe a training set for an AI or algorithm.

9. How the ground truth for the training set was established

Cannot be provided. This document does not describe a training set or its ground truth establishment.

Summary of what the document does provide:

Device: ADVANCE® 913 Medial Pivot Tibial Insert and ADVANCE® 913 Medial Pivot Tibial Base.
Intended Use/Indications: For use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with conditions like noninflammatory degenerative joint disease (osteoarthritis, traumatic arthritis, avascular necrosis), inflammatory degenerative joint disease (rheumatoid arthritis), correction of functional deformity, revision procedures, and treatment of unmanageable fractures.
Materials: Tibial Insert: UHMWPE conforming to ASTM F648. Tibial Base: Cobalt Chrome alloy conforming to ASTM F75.
Regulatory Context: This is a 510(k) premarket notification claiming substantial equivalence to previously cleared predicate devices. The safety and effectiveness are supported by "substantial equivalence information, materials information and the analysis data provided within this Premarket Notification," not necessarily by direct performance testing against acceptance criteria in this summary.
Predicate Devices: The indications for use and design features are stated to be identical or substantially equivalent to previously cleared predicate devices.

Summary

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

Image /page/0/Picture/0 description: The image contains the alphanumeric string "K092201" written in a cursive style. To the right of this string, there is a symbol that resembles a number sign followed by "1/2". The text and symbol are written in black ink on a white background.

AUG 200 2009

ADVANCE® 913 Medial Pivot SPECIAL 510(k) Summary of Safety and Effectiveness

In accordance with the food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807, this information serves as a Summary of Safety and Effectiveness for the use of the ADVANCE® 913 Medial Pivot Tibial Insert and Base.

Submitted By:

Primary Contact:

Proprietary Name:

Common Name:

Classification Name and Reference:

Wright Medical Technology, Inc.

Sarah Fairfield

ADVANCE® 913 Medial Pivot Tibial Base ADVANCE® 913 Medial Pivot Tibial Insert

Tibial Base Tibial Insert

21 CFR 888.3560 Knee, Patellofemorotibial, Semi-constrained, cemented, Polymer/ metal/polymer Orthopedics/87/ JWH

Device Product Code and Panel Code:

A. INTENDED USES/ INDICATIONS

The ADVANCE® 913 Medial Pivot Tibial Insert and ADVANCE® 913 Medial Pivot Tibial Base are indicated for use in knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions:

1. noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
1. inflammatory degenerative joint disease including rheumatoid arthritis;
1. correction of functional deformity;
1. revision procedures where other treatments or devices have failed; and
1. treatment of fractures that are unmanageable using other techniques.

ADVANCE® 913 Medial Pivot Tibial Base and Insert Components are for usc with bone cement.

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

K092201 #2/2

B. DEVICE DESCRIPTION

Tibial Insert

The design features of the ADVANCE® 913 Medial Pivot Tibial Insert are summarized below:

Manufactured from UHMWPE conforming to ASTM F648 .
Sizes: 1-5 Left & Right .
Thickness: 10, 12, 14, 17 mm .

Tibial Base

The design features of the ADVANCE® 913 Medial Pivot Tibial Base are summarized below:

Manufactured from Cobalt Chrome alloy conforming to ASTM F75 .
Sizes: 1-5 plus .
Symmetrical .
No screw holes .

C. SUBSTANTIAL EQUIVALENCE INFORMATION

The indications for use for the ADVANCE® 913 Medial Pivot Tibial Insert and the ADVANCE® 913 Medial Pivot Tibial Base are identical to the indications for use for the previously cleared predicate devices. The design features of the subject devices are substantially equivalent to those of the predicate devices. The fundamental scientific technology of the modified device has not changed relative to the predicate devices. The safety and effectiveness of the ADVANCE® 913 Medial Pivot Tibial Insert and the ADVANCE® 913 Medial Pivot Tibial Base is adequately supported by the substantial equivalence information, materials information and the analysis data provided within this Premarket Notification.

{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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

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

Wright Medical Technology, Inc. % Ms. Sarah Fairfield Regulatory Affairs Specialist 5677 Airline Road Arlington, Tennessee 38002

AUG 200 2009

Re: K092201

Trade/Device Name: ADVANCE 913 Medial Pivot Tibial Insert, ADVANCE 913 Medial Pivot Tibial Base

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: July 14, 2009 Received: July 22, 2009

Dear Ms. Fairfield:

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 (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 - Ms. Sarah Fairfield

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/cdrh/comp/ for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Barbara Buchner

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

Enclosure

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

Indications for Use

510(k) Number (if known): KO92201

Device Name: ADVANCE® 913 Medial Pivot Tibial Insert ADVANCE® 913 Medial Pivot Tibial Base

Indications For Use:

noninflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascular necrosis

1. inflammatory degenerative joint disease including rheumatoid arthritis:

correction of functional deformity;
revision procedures where other treatments or devices have failed: and
treatment of fractures that are unmanageable using other techniques.

ADVANCE® 913 Medial Pivot Tibial Base and Insert Components are for use with bone cement.

Prescription Use XXX (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

1 of 1

Anitta for mxn
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K092201

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.