Hintermann Series H2
Hintermann Series H2 Tibia Implant, Sz6 Right, 9.5mm
1manufacturer
153catalogue numbers in this listing
2510(k) clearances naming this product code
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 | 2025-09-05 |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Sterilisation | Radiation 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-37605 | 6 N RIGHT 5mm | In distribution |
| HT-38617 | 6 A LEFT 7mm | In distribution |
| HT-31834 | 12mm 4 RIGHT | In distribution |
| HT-38609 | 6 N LEFT 9mm | In distribution |
| HT-38119 | 1 A LEFT 9mm | In distribution |
| HT-31836 | 12mm 6 RIGHT | In distribution |
| HT-38206 | 2 N LEFT 6mm | In distribution |
| HT-38007 | 0 N LEFT 7mm | In distribution |
| HT-38619 | 6 A LEFT 9mm | In distribution |
| HT-38405 | 4 N LEFT 5mm | In distribution |
| HT-31832 | 12mm 2 RIGHT | In distribution |
| HT-32825 | 9.5mm 5 LEFT | In distribution |
| HT-37516 | 5 A RIGHT 6mm | In distribution |
| HT-38019 | 0 A LEFT 9mm | In distribution |
| HT-32833 | 12mm 3 LEFT | In distribution |
| HT-38106 | 1 N LEFT 6mm | In distribution |
| HT-38117 | 1 A LEFT 7mm | In distribution |
| HT-37416 | 4 A RIGHT 6mm | In distribution |
| HT-32804 | 7mm 4 LEFT | In distribution |
| HT-37009 | 0 N RIGHT 9mm | In distribution |
| HT-37109 | 1 N RIGHT 9mm | In distribution |
| HT-38409 | 4 N LEFT 9mm | In distribution |
| HT-37107 | 1 N RIGHT 7mm | In distribution |
| HT-31805 | 7mm 5 RIGHT | In distribution |
| HT-37205 | 2 N RIGHT 5mm | In distribution |
| HT-32836 | 12mm 6 LEFT | In distribution |
| HT-38507 | 5 N LEFT 7mm | In distribution |
| HT-37217 | 2 A RIGHT 7mm | In distribution |
| HT-32803 | 7mm 3 LEFT | In distribution |
| HT-38016 | 0 A LEFT 6mm | In distribution |
| HT-38006 | 0 N LEFT 6mm | In distribution |
| HT-31826 | 9.5mm 6 RIGHT | In distribution |
| HT-37616 | 6 A RIGHT 6mm | In distribution |
| HT-37409 | 4 N RIGHT 9mm | In distribution |
| HT-37519 | 5 A RIGHT 9mm | In distribution |
| HT-37207 | 2 N RIGHT 7mm | In distribution |
| HT-37206 | 2 N RIGHT 6mm | In distribution |
| HT-32835 | 12mm 5 LEFT | In distribution |
| HT-38517 | 5 A LEFT 7mm | In distribution |
| HT-37209 | 2 N RIGHT 9mm | In distribution |
| HT-32802 | 7mm 2 LEFT | In distribution |
| HT-38417 | 4 A LEFT 7mm | In distribution |
| HT-38209 | 2 N LEFT 9mm | In distribution |
| HT-38607 | 6 N LEFT 7mm | In distribution |
| HT-31822 | 9.5mm 2 RIGHT | In distribution |
| HT-37615 | 6 A RIGHT 5mm | In distribution |
| HT-38309 | 3 N LEFT 9mm | In distribution |
| HT-32831 | 12mm 1 LEFT | In distribution |
| HT-38307 | 3 N LEFT 7mm | In distribution |
| HT-31801 | 7mm 1 RIGHT | In distribution |
| HT-37507 | 5 N RIGHT 7mm | In distribution |
| HT-38317 | 3 A LEFT 7mm | In distribution |
| HT-38219 | 2 A LEFT 9mm | In distribution |
| HT-38316 | 3 A LEFT 6mm | In distribution |
| HT-37417 | 4 A RIGHT 7mm | In distribution |
| HT-37015 | 0 A RIGHT 5mm | In distribution |
| HT-31806 | 7mm 6 RIGHT | In distribution |
| HT-38216 | 2 A LEFT 6mm | In distribution |
| HT-37215 | 2 A RIGHT 5mm | In distribution |
| HT-31823 | 9.5mm 3 RIGHT | In distribution |
| HT-31821 | 9.5mm 1 RIGHT | In distribution |
| HT-37407 | 4 N RIGHT 7mm | In distribution |
| HT-32805 | 7mm 5 LEFT | In distribution |
| HT-32821 | 9.5mm 1 LEFT | In distribution |
| HT-38506 | 5 N LEFT 6mm | In distribution |
| HT-37515 | 5 A RIGHT 5mm | In distribution |
| HT-31825 | 9.5mm 5 RIGHT | In distribution |
| HT-38419 | 4 A LEFT 9mm | In distribution |
| HT-37617 | 6 A RIGHT 7mm | In distribution |
| HT-37315 | 3 A RIGHT 5mm | In distribution |
| HT-38107 | 1 N LEFT 7mm | In distribution |
| HT-38406 | 4 N LEFT 6mm | In distribution |
| HT-38306 | 3 N LEFT 6mm | In distribution |
| HT-32834 | 12mm 4 LEFT | In distribution |
| HT-31831 | 12mm 1 RIGHT | In distribution |
| HT-32806 | 7mm 6 LEFT | In distribution |
| HT-31833 | 12mm 3 RIGHT | In distribution |
| HT-38105 | 1 N LEFT 5mm | In distribution |
| HT-38606 | 6 N LEFT 6mm | In distribution |
| HT-37419 | 4 A RIGHT 9mm | In distribution |
| HT-37307 | 3 N RIGHT 7mm | In distribution |
| HT-32824 | 9.5mm 4 LEFT | In distribution |
| HT-31503 | R/L, 3 | In distribution |
| HT-32823 | 9.5mm 3 LEFT | In distribution |
| HT-37619 | 6 A RIGHT 9mm | In distribution |
| HT-37319 | 3 A RIGHT 9mm | In distribution |
| HT-31506 | R/L, 6 | In distribution |
| HT-37116 | 1 A RIGHT 6mm | In distribution |
| HT-37006 | 0 N RIGHT 6mm | In distribution |
| HT-37305 | 3 N RIGHT 5mm | In distribution |
| HT-38616 | 6 A LEFT 6mm | In distribution |
| HT-38505 | 5 N LEFT 5mm | In distribution |
| HT-37106 | 1 N RIGHT 6mm | In distribution |
| HT-38519 | 5 A LEFT 9mm | In distribution |
| HT-31802 | 7mm 2 RIGHT | In distribution |
| HT-38615 | 6 A LEFT 5mm | In distribution |
| HT-37105 | 1 N RIGHT 5mm | In distribution |
| HT-38207 | 2 N LEFT 7mm | In distribution |
| HT-38605 | 6 N LEFT 5mm | In distribution |
| HT-38009 | 0 N LEFT 9mm | In distribution |
| HT-37019 | 0 A RIGHT 9mm | In distribution |
| HT-37309 | 3 N RIGHT 9mm | In distribution |
| HT-38305 | 3 N LEFT 5mm | In distribution |
| HT-37005 | 0 N RIGHT 5mm | In distribution |
| HT-38509 | 5 N LEFT 9mm | In distribution |
| HT-31835 | 12mm 5 RIGHT | In distribution |
| HT-37317 | 3 A RIGHT 7mm | In distribution |
| HT-38115 | 1 A LEFT 5mm | In distribution |
| HT-37517 | 5 A RIGHT 7mm | In distribution |
| HT-38415 | 4 A LEFT 5mm | In distribution |
| HT-38015 | 0 A LEFT 5mm | In distribution |
| HT-31824 | 9.5mm 4 RIGHT | In distribution |
| HT-37115 | 1 A RIGHT 5mm | In distribution |
| HT-31504 | R/L, 4 | In distribution |
| HT-37007 | 0 N RIGHT 7mm | In distribution |
| HT-37406 | 4 N RIGHT 6mm | In distribution |
| HT-32822 | 9.5mm 2 LEFT | In distribution |
| HT-38205 | 2 N LEFT 5mm | In distribution |
| HT-37117 | 1 A RIGHT 7mm | In distribution |
| HT-38319 | 3 A LEFT 9mm | In distribution |
| HT-38017 | 0 A LEFT 7mm | In distribution |
| HT-37505 | 5 N RIGHT 5mm | In distribution |
| HT-38116 | 1 A LEFT 6mm | In distribution |
| HT-37607 | 6 N RIGHT 7mm | In distribution |
| HT-38315 | 3 A LEFT 5mm | In distribution |
| HT-37306 | 3 N RIGHT 6mm | In distribution |
| HT-38515 | 5 A LEFT 5mm | In distribution |
| HT-38416 | 4 A LEFT 6mm | In distribution |
| HT-38215 | 2 A LEFT 5mm | In distribution |
| HT-37509 | 5 N RIGHT 9mm | In distribution |
| HT-38217 | 2 A LEFT 7mm | In distribution |
| HT-37016 | 0 A RIGHT 6mm | In distribution |
| HT-38407 | 4 N LEFT 7mm | In distribution |
| HT-37415 | 4 A RIGHT 5mm | In distribution |
| HT-37609 | 6 N RIGHT 9mm | In distribution |
| HT-37506 | 5 N RIGHT 6mm | In distribution |
| HT-31804 | 7mm 4 RIGHT | In distribution |
| HT-31803 | 7mm 3 RIGHT | In distribution |
| HT-31501 | R/L, 1/2 | In distribution |
| HT-37219 | 2 A RIGHT 9mm | In distribution |
| HT-38005 | 0 N LEFT 5mm | In distribution |
| HT-37606 | 6 N RIGHT 6mm | In distribution |
| HT-37316 | 3 A RIGHT 6mm | In distribution |
| HT-37216 | 2 A RIGHT 6mm | In distribution |
| HT-32801 | 7mm 1 LEFT | In distribution |
| HT-32826 | 9.5mm 6 LEFT | In distribution |
| HT-31505 | R/L, 5 | In distribution |
| HT-38109 | 1 N LEFT 9mm | In distribution |
| HT-32832 | 12mm 2 LEFT | In distribution |
| HT-37017 | 0 A RIGHT 7mm | In distribution |
| HT-37405 | 4 N RIGHT 5mm | In distribution |
| HT-38516 | 5 A LEFT 6mm | In distribution |
| HT-37119 | 1 A RIGHT 9mm | 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 |
| Trabecular Metal® | Zimmer, Inc. | 145 |
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.