Hintermann Series
Hintermann Series talar components form the lower implant surface in an ankle replacement. In the H2 system, a talar component works with the H2 tibial component and a polyethylene inlay to…
Hintermann Series talar components form the lower implant surface in an ankle replacement. In the H2 system, a talar component works with the H2 tibial component and a polyethylene inlay to replace the ankle articulation.
The H2 configuration has plasma-sprayed titanium on the cement-contacting surfaces of the tibial and talar components. Its updated polyethylene inlay uses vitamin E blended ultra-high-molecular-weight polyethylene.
Listed Item
Hintermann Series Talar Implant, Sz4 RIght, Flat Cut- SINGLE COAT
Component Matching
The tibial component, polyethylene inlay and talar implant are used together as a system. Smaller component sizes provide additional fit options, and the H2 configuration is intended for cemented use in the United States.
Who Else Makes It
Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
Record
| Listed by | Vilex LLC, United States |
|---|---|
| FDA product code | HSN |
| Device type | Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3110 |
| Establishment | Repacker / relabeller, Manufacturer |
| 510(k) | K240475 |
| Record published | 2025-09-17 |
| Record revised | 2026-01-19 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Store in a dry place |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HT-39101 | N/A | In distribution |
| HT-39546 | N/A | In distribution |
| HT-401112 | SIZE 2 RIGHT | In distribution |
| HT-39353 | N/A | In distribution |
| HT-402110 | SIZE 0 LEFT | In distribution |
| HT-401115 | SIZE 5 RIGHT | In distribution |
| HT-39204 | N/A | In distribution |
| HT-39362 | N/A | In distribution |
| HT-39325 | N/A | In distribution |
| HT-39320 | N/A | In distribution |
| HT-401111 | SIZE 1 RIGHT | In distribution |
| HT-39363 | N/A | In distribution |
| HT-401124 | SIZE 4 RIGHT | In distribution |
| HT-39525 | N/A | In distribution |
| HT-39202 | N/A | In distribution |
| HT-39315 | N/A | In distribution |
| HT-39545 | N/A | In distribution |
| HT-39542 | N/A | In distribution |
| HT-39321 | N/A | In distribution |
| HT-39361 | N/A | In distribution |
| HT-39311 | N/A | In distribution |
| HT-39541 | N/A | In distribution |
| HT-39354 | N/A | In distribution |
| HT-402121 | SIZE 1 LEFT | In distribution |
| HT-402114 | SIZE 4 LEFT | In distribution |
| HT-401125 | SIZE 5 RIGHT | In distribution |
| HT-39355 | N/A | In distribution |
| HT-39104 | N/A | In distribution |
| HT-39102 | N/A | In distribution |
| HT-39103 | N/A | In distribution |
| HT-401123 | SIZE 3 RIGHT | In distribution |
| HT-402111 | SIZE 1 LEFT | In distribution |
| HT-401121 | SIZE 1 RIGHT | In distribution |
| HT-39543 | N/A | In distribution |
| HT-401116 | SIZE 6 RIGHT | In distribution |
| HT-39206 | N/A | In distribution |
| HT-402115 | SIZE 5 LEFT | In distribution |
| HT-402113 | SIZE 3 LEFT | In distribution |
| HT-402125 | SIZE 5 LEFT | In distribution |
| HT-401110 | SIZE 0 RIGHT | In distribution |
| HT-39364 | N/A | In distribution |
| HT-39312 | N/A | In distribution |
| HT-39352 | N/A | In distribution |
| HT-39205 | N/A | In distribution |
| HT-39313 | N/A | In distribution |
| HT-401113 | SIZE 3 RIGHT | In distribution |
| HT-39529 | N/A | In distribution |
| HT-39351 | N/A | In distribution |
| HT-39203 | N/A | In distribution |
| HT-39324 | N/A | In distribution |
| HT-39544 | N/A | In distribution |
| HT-39322 | N/A | In distribution |
| HT-402124 | SIZE 4 LEFT | In distribution |
| HT-402116 | SIZE 6 LEFT | In distribution |
| HT-401122 | SIZE 2 RIGHT | In distribution |
| HT-39106 | N/A | In distribution |
| HT-39105 | N/A | In distribution |
| HT-39526 | N/A | In distribution |
| HT-39316 | N/A | In distribution |
| HT-39310 | N/A | In distribution |
| HT-39201 | N/A | In distribution |
| HT-39365 | N/A | In distribution |
| HT-402123 | SIZE 3 LEFT | In distribution |
| HT-401114 | SIZE 4 RIGHT | In distribution |
| HT-39326 | N/A | In distribution |
| HT-39527 | N/A | In distribution |
| HT-39323 | N/A | In distribution |
| HT-402122 | SIZE 2 LEFT | In distribution |
| HT-402112 | SIZE 2 LEFT | In distribution |
| HT-39314 | N/A | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Apex 3D Total Ankle Replacement System | Paragon 28 | 658 |
| Vantage | Exactech, Inc. | 362 |
| Cadence™ | Ascension Orthopedics, Inc. | 248 |
| Cadence Total Ankle System | Smith & Nephew, Inc. | 246 |
| Inbone | Wright Medical Technology, Inc. | 236 |
| Hintermann Series H2 | DT Medtech LLC | 225 |
| Infinity | Wright Medical Technology, Inc. | 220 |
| Incompass Total Ankle System | Wright Medical Technology, Inc. | 213 |
| Invision | Wright Medical Technology, Inc. | 186 |
| Kinos Axiom Instrumentation | restor3d, inc. | 169 |
| Quantum | In2Bones SAS | 157 |
| Hintermann Series H2 | Vilex LLC | 153 |
Showing 12 of 53. All products under Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K240475 | 2024-12-02 |
| K230462 | 2023-07-17 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.