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Tendon Wrap Tendon Protector

by Integra Lifesciences Corporation

510(k) K053655

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK053655 Date3 Feb 2006ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FTM
Device Class
Class II
Regulation
21 CFR Part 878.3300
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a surgical mesh used for tendon protection and reinforcement. It is designed to enhance the stability of tendon reconstruction following a tendon rupture.

It is supplied as a sheet and is intended for use in tendon injuries that have not had substantial tissue loss. The device is made of a porous matrix of cross-linked, highly purified type I collagen and glycosaminoglycan (GAG), providing a biocompatible environment and gliding surface to protect tendons during healing. It received FDA 510(k) clearance (K053655) and is classified as a Class II device under regulation number 878.3300.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Tendon Wrap Tendon Protector used for?

    It is used to enhance the stability of tendon reconstruction following a tendon rupture, providing protection and reinforcement for tendons during healing in injuries without substantial tissue loss.

  • How is the Tendon Wrap Tendon Protector supplied and what is it made of?

    It is supplied as a sheet made of a porous matrix of cross-linked, highly purified type I collagen and glycosaminoglycan (GAG), which creates a biocompatible environment and gliding surface to protect tendons during healing.

  • Is the Tendon Wrap Tendon Protector sterile and intended for single use?

    The device data does not specify sterility or single-use status; however, as a surgical implant intended for tendon reinforcement, it is typically provided sterile and designed for single-use implantation during surgery.