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TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis

by TMJ Concepts

PMA P980052

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

3 ongoing

This device is named in the recall

Documents

PMA P980052↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP980052 Date2 Jul 1999ApprovedStatusActive

Recalls

4 recalls · 3 ongoing · FDA

    • Ongoing Z-2524-2026 FDA Class II initiated 11 Feb 2026

    Custom temporomandibular joint implant may have contained incorrect patient-specific components that led to a poor fit of the implant, leading to a right-sided open bite.

    • Ongoing Z-0488-2026 FDA Class I initiated 13 Oct 2025

    Patient-fitted temporomandibular joint implant contained discrepancy in screw hole position.

    • Ongoing Z-1234-2023 FDA Class II initiated 6 Dec 2022

    Device was shipped without having regulatory approval.

    • Terminated Z-1444-2018 FDA Class II initiated 12 Mar 2018

    This device was mislabeled and is not the correct component for this patient.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

PMA

Generic Name
Joint, temporomandibular, implant
FDA applicant
Stryker Leibinger, GmbH & Co KG
PMA Number
FDA Product Code
LZD
Device Class
Class III
Regulation
21 CFR Part 872.3940
Advisory Committee
Dental
FDA Decision
APPR Approved

Overview

AI-generated summary, 18 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 TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis is a temporomandibular joint implant classified as a joint, temporomandibular, implant. It is designed for reconstruction of the temporomandibular joint in patients with conditions such as inflammatory arthritis, recurrent ankylosis, failed tissue grafts, or structural loss due to bone resorption, trauma, developmental abnormalities, or pathologic lesions.

This device is supplied as a custom-fitted prosthesis and is intended for surgical implantation by dental professionals. It is regulated under FDA Premarket Approval (PMA) with approval number P980052, and its use is governed by the classification code LZD under regulation number 872.3940. The device is manufactured by Stryker Leibinger GmbH & Co KG, with specifications and approvals documented in the Federal Register under docket number 99M-2551.