Prosthetic devices · 21 CFR 872 Subpart D
Implant Temporomandibular Joint
Call for PMAs to be filed by 3/30/99 per 63 FR 71746 on 12/30/98 - Indicated for reconstruction of the temporomandibular joint.
- Companies listing it
- 76 makers
- Brands and models
- 5
- 510(k) clearances
- 00 in five years
- FDA name
- Joint, Temporomandibular, Implant
Companies that list LZD
7 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Stryker | United States | Maker | TMJ Concepts | 33 | 2024 |
| Biomet Microfixation | United States | Maker | TMJ | 8 | 2021 |
| Unique Instruments Inc. | United States | Maker | Diamond Bur | — | — |
| Andersen Scientific, Inc. | United States | Maker | Orthotin TMJ Replacement | — | — |
| APS Materials, Inc | United States | Maker | — | — | — |
| OrthoTin LLC | United States | Maker | — | — | — |
| STERIS Corporation | United States | Contract sterilizer | Zimmer (LN) - Total Temporomandibular Joint Replacement System | — | — |
Official records: FDA product classification for LZD · 21 CFR 872.3940.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026