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Integra TITAN Reverse Shoulder System

by Integra Lifesciences Corporation 4 variants

510(k) K161189

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 NumberK161189 Date25 Aug 2016ClearedStatusActive

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  • Withdrawn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
PHX
Device Class
Class II
Regulation
21 CFR Part 888.3660
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

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

The Integra Titan Reverse Shoulder System is a shoulder prosthesis in a reverse configuration, designed to address patients with a grossly deficient rotator cuff joint with severe arthropathy or a previous failed joint replacement. It is intended for patients with a joint that is anatomically and structurally suited to receive the selected implants and a functional deltoid. The system complements the existing Titan Shoulder portfolio.

The Integra Titan Reverse Shoulder System is supplied with modularity, allowing for version and height adjustment for increased stability. It has 3 reverse body height options to fine-tune soft tissue tension without over-lateralizing the humerus. The system has received FDA 510(k) clearance, classified as a Shoulder Prosthesis, Reverse Configuration.

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Questions

AI-generated answers, 25 Sep 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 Integra TITAN Reverse Shoulder System used for?

    The Integra TITAN Reverse Shoulder System is used to address patients with a grossly deficient rotator cuff joint with severe arthropathy or a previous failed joint replacement, providing a reverse configuration shoulder prosthesis.

  • Is the Integra TITAN Reverse Shoulder System supplied with modularity?

    Yes, the system is supplied with modularity, allowing for version and height adjustment for increased stability, with 3 reverse body height options to fine-tune soft tissue tension.

  • What is the regulatory status of the Integra TITAN Reverse Shoulder System?

    The system has received FDA 510(k) clearance, classified as a Shoulder Prosthesis, Reverse Configuration, and is considered substantially equivalent.

  • What type of patients is the Integra TITAN Reverse Shoulder System intended for?

    The system is intended for patients with a joint that is anatomically and structurally suited to receive the selected implants and a functional deltoid.