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Restore Orthobiologic Soft Tissue Implant

by Depuy, Inc.

510(k) K982330

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 NumberK982330 Date25 Sep 1998ClearedStatusActive

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  • Withdrawn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)

Full name
Depuy Orthotech Restore Orthobiologic Soft Tissue Implant
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.

The Restore Orthobiologic Soft Tissue Implant is a surgical mesh device designed for soft tissue reinforcement. It is classified as a mesh, surgical implant intended to provide structural support in areas where soft tissue weakness exists, particularly during procedures such as rotator cuff repair. The implant is engineered to be secured via sutures or suture anchors, aiding in the stabilization of repaired tissues.

This device is supplied sterile and intended for single-use in general surgical settings. It is categorized under FDA product code FTM and holds a 510(k) clearance (K982330) with a decision of Substantially Equivalent (SESE). The implant is regulated under the FDA’s medical device classification system, specifically under regulation number 878.3300, and is intended for use in plastic surgery applications. No MRI safety information or reusable specifications are provided.

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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 Restore Orthobiologic Soft Tissue Implant used for?

    This implant is designed to provide structural support in areas where soft tissue weakness exists, particularly during procedures like rotator cuff repair. It reinforces soft tissue by acting as a mesh that can be secured with sutures or suture anchors, helping stabilize repaired tissues.

  • How is the Restore Orthobiologic Soft Tissue Implant supplied?

    The implant is supplied sterile and is intended for single-use in general surgical settings. This ensures safety and compliance with medical standards, preventing cross-contamination between patients.

  • Is the Restore Orthobiologic Soft Tissue Implant reusable?

    No, the device is explicitly intended for single-use only. Reusing medical implants like this can compromise sterility and patient safety, which is why it is designed for one-time surgical use.

  • What regulatory approval does the Restore Orthobiologic Soft Tissue Implant hold?

    The implant holds an FDA 510(k) clearance (K982330) and is classified under regulation number 878.3300. It is categorized under the product code FTM and is intended for use in plastic surgery applications, with a decision of Substantially Equivalent (SESE).

  • Are there different sizes or models available for the Restore Orthobiologic Soft Tissue Implant?

    The provided data lists multiple registration numbers (e.g., 2183620, 2245304) and FEI numbers, which may correspond to different sizes or models of the implant. These identifiers are used for regulatory tracking and could indicate variations in dimensions or configurations. For precise sizing details, consult the manufacturer’s product catalog or specifications.