Prosthesis, Ankle, Uncemented, Non-Constrained
FDA product code NTG · Class III (high risk) · Orthopedic
An ankle joint metal/polymer non-constrained uncemented prosthesis is a device intended to be implanted to replace an ankle joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a tibial component made of alloys, such as cobalt-chromium-molybdenum, and a talar component made of ultra-high molecular weight polyethylene.
0510(k) clearances
2PMA approvals
4recalls
Implantimplanted device
PMA approvals
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2399-2026 Class II | Hintermann Series Talar Implant, Left, Size 2 REF 302112Through customer complaints, the ankle replacement system was found to contain incorrect devices: Left… | DT MedTech, LLC | 03/24/2026Open, Classified |
| Z-0588-2024 Class II | Exactech Vantage Mobile Bearing Tibial Inserts, Catalog Numbers: a) 350-41-23, b)…Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag. | Exactech, Inc. | 11/21/2023Open, Classified |
| Z-0403-2019 Class II | DT Medi Tech Hintermann Series Talar Implant LEFT-SIZE 4 Part Number: 302114 components…Incorrect package labeling identifying the device | DT MedTech, LLC | 09/25/2018Terminated |
| Z-0402-2019 Class II | DT Medical -Hintermann Series H3 Poly Inlay, Size 3 5mm Part Number: 300305 components…Incorrect package labeling identifying the device | DT MedTech, LLC | 09/25/2018Terminated |