Surgical devices · 21 CFR 872 Subpart E
Temporary Mandibular Condyle Prosthesis
FDA device type “Prosthesis, Condyle, Mandibular, Temporary”.
- Companies listing it
- 109 makers
- Brands and models
- 18
- 510(k) clearances
- 70 in five years
- FDA name
- Prosthesis, Condyle, Mandibular, Temporary
510(k) clearances per year, 1976–2026
Companies that list NEI
10 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| KLS Martin SE & Co. KG | Germany | Maker | — | 43 | 2026 |
| Stryker | United States | Maker | Stryker Temporary Condylar Prosthesis | 33 | 2024 |
| Osteomed, LLC | United States | Maker | — | 26 | 2022 |
| Zimmer Inc | United States | Maker | ADD-ON CONDYLE · TRAUMAONE SYSTEM | 14 | 2001 |
| Biomet Microfixation | United States | Maker | Add on Condyle | 8 | 2021 |
| SYNTHES (USA) Products LLC | United States | Maker | DePuy Synthes Maxillofacial Portfolio - MR Conditional · MODIFICATION TO SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM · SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM · SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEA | 7 | 2020 |
| SYNTHES GMBH / Synthes Produktions GmbH | United States | Maker | Condylar Head Add-on-System · LOCKING RECONSTRUCTION · SYNTHES (USA) CONDYLAR HEAD ADD-ON | 5 | 2013 |
| Jabil Inc. | United States | Maker | Condylar Head Add-on-System · DePuy Synthes Maxillofacial Portfolio - MR Conditional · LOCKING RECONSTRUCTION · SYNTHES (USA) CONDYLAR HEAD ADD-ON | — | — |
| Autocam Medical | United States | Maker | — | — | — |
| Exel Inc. dba DHL Supply Chain (USA) | United States | Repacker / relabeler | MODIFICATION TO SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM · SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM · SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEAD | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 9 Apr 2014 | K133285 | STRYKER TEMPORARY CONDYLAR PROSTHESIS | Stryker |
| 5 Sep 2008 | K081747 | MODIFICATION TO SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM | Synthes (Usa) |
| 5 Jan 2007 | K063181 | SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM | Synthes (Usa) |
| 8 Jul 2004 | K031701 | OSTEOMED TEMPORARY CONDYLAR ATTACHMENT SYSTEM | Osteomed, LLC |
| 6 Aug 2001 | K002790 | ADD-ON CONDYLE | Walter Lorenz Surgical, Inc. |
| 27 Jul 2001 | K990667 | KLS-MARTIN TEMPORARY CONDYLAR IMPLANT | KLS Martin SE & Co. KG |
| 22 Oct 1999 | K990637 | SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEAD | Synthes (Usa) |
Official records: FDA product classification for NEI · 21 CFR 872.4770.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026