Total ankle arthroplasty is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint. Total ankle arthroplasty is indicated for patients with ankle joints damaged by severe rheumatoid, post traumatic or degenerative arthritis.

The Agility Ankle Revision Prosthesis is additionally indicated for patients with a failed previous ankle surgery.

CAUTION: The Agility Ankle Prosthesis is intended for cemented use only.

Device Description

The Agility Ankle Revision Prosthesis is a modular ankle prosthesis that is comprised of a tibial tray, a polyethylene tibial insert and a revision talar component. The Agility Ankle revision talar component is designed to replace the Agility Ankle primary talar component in revision ankle arthroplasty. It is designed for use with the existing Agility Ankle tibial tray and either the existing polyethylene tibial insert or revision (+2) tibial insert.

The distal surface of the Agility Ankle revision talar component is a rectangular shape and is designed with a fin in the anterior-posterior plane to be cemented into the bone. This distal surface and fin are porous coated with Porocoat. The superior surface is a convex shaped and highly polished to articulate with the polyethylene tibial insert.

The Agility Ankle revision (+2) tibial insert component is manufactured from Ultra High Molecular Weight Polyethylene. It is designed to slide into the existing Agility Ankle tibial tray and is designed to articulate with either the primary or revision Agility Ankle talar components. As with the current tibial insert, the revision insert is designed with lateral and medial ears that slide into the grooves of the tibial tray. The only difference is that the revision insert is 2mm thicker to allow the insert to be used in revision cases and in primary cases where the soft tissues surrounding the ankle are lax.

AI/ML Overview

The provided text is a 510(k) summary for the Agility Ankle Revision Prosthesis. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving that a new device meets specific acceptance criteria through a study. Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study to prove device performance.

Specifically:

No table of acceptance criteria and reported device performance is present. The document focuses on demonstrating equivalence to a previously cleared device (K920802, the Agility Ankle).
No study data related to sample size, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, or training set information is included.
The document explicitly states that "The determination of substantial equivalence for this device was based on a detailed device description, and conformance with voluntary performance standards," rather than a new clinical or performance study demonstrating novel acceptance criteria.

The 510(k) process primarily relies on comparing a new device to an existing, legally marketed predicate device to establish that the new device is as safe and effective as the predicate. It generally does not require new clinical trials or studies to establish performance against novel acceptance criteria unless the device has significant differences in technological characteristics or indications for use from the predicate.

Summary

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MAY 2 0 2002

510(k) Summary . Agility Ankle Revision Prosthesis

DePuy, Inc. 700 Orthopaedic Drive Warsaw, IN 46581

A. Contact Person:

Janet G. Johnson, RAC Group Leader, Regulatory Submissions (219) 371-4907

B. Device Information:

Proprietary Name:	Agility Ankle Revision Prosthesis
Common Name:	Ankle Prosthesis
Classification Name and Regulatory Class:	Ankle Joint metal/polymer semi-constrained cemented prosthesis: Class II per 21 CFR §888.3110
Product Code:	87 HSN

C. Indications for Use:

The Agility Ankle Revision Prosthesis is additionally indicated for patients with a failed previous ankle surgery.

CAUTION: The Agility Ankle Prosthesis is intended for cemented use only.

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510(k) Summary Agility Ankle Revision Prosthesis (continued)

D. Device Description:

E. Substantial Equivalence:

The substantial equivalence of the Agility Ankle Revision Prosthesis is demonstrated by its similarity in indications for use, design, materials, sterilization and packaging to the Agility Ankle cleared in K920802 (formerly called the Alvine Ankle).

The determination of substantial equivalence for this device was based on a detailed device description, and conformance with voluntary performance standards.

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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. Inside the circle is an abstract image of an eagle.

MAY 2 0 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Janet G. Johnson, RAC Group Leader, Regulatory Submissions Depuy Orthopaedics Incorporated 700 Orthopaedic Drive PO Box 988 Warsaw, Indiana 46581-0988

Re: K020541

Trade Name: Agility Revision Ankle Regulation Number: 888.3110 Regulation Name: Ankle joint metal/polymer semi-constrained cemented prosthesis Class: II Product Code: HSN Dated: February 18, 2002 Received: February 19, 2002

Dear Ms. Johnson:

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.

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Page 2 -- Ms. Janet G. Johnson, RAC

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,

Mark N McMillan

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

Enclosure

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510(k) Number (if known) Device Name

54 Agility Ankle Revision Prosthesis

Indications for Use

The Agility Ankle Revision Prosthesis is additionally indicated for patients with a failed previous ankle surgery.

CAUTION: The Agility Ankle Prosthesis is intended for cemented use only.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR §801.109) OR

Over-the-Counter Use_

(Optional Format 1-2-96)

for Mark N. Millhazer

(Division Sign-Off) Division of General, Restorative and Neurological Devices

KO20541 510(k) Number ________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 888.3110 Ankle joint metal/polymer semi-constrained cemented prosthesis.

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