Kinos Axiom Total Ankle Replacement
Kinos Axiom tibial implant is the tibia-side component of a fixed-bearing total ankle replacement. The line-extension implant is additively manufactured from Ti-6Al-4V titanium alloy and…
Kinos Axiom tibial implant is the tibia-side component of a fixed-bearing total ankle replacement. The line-extension implant is additively manufactured from Ti-6Al-4V titanium alloy and has a modified stem for fixation in the tibia.
A bearing component attaches to the tibial implant during surgery and articulates against a separate talar component. The resulting semi-constrained construct replaces the ankle’s articulating surfaces and permits flexion-extension movement.
Listed Item
X-Stem Implant, Standard, Size 5, Extra Long with Tidal Technology
Use and Fixation
The system treats severe rheumatoid, post-traumatic or degenerative ankle arthritis and failed previous ankle surgery. It is intended for use with bone cement. The listed X-Stem is an implant component within that replacement system.
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 | restor3d, inc., 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 | Complaint-file establishment, Manufacturer |
| 510(k) | K232595 |
| Record published | 2024-01-18 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1834-0131 | In distribution | |
| 1834-0052 | In distribution | |
| 1834-0051 | In distribution | |
| 2832-1003 | In distribution | |
| 1834-0110 | In distribution | |
| 2832-1002 | In distribution | |
| 1834-0141 | In distribution | |
| 2832-2002 | In distribution | |
| 1834-0041 | In distribution | |
| 2832-2004 | In distribution | |
| 2832-1001 | In distribution | |
| 1834-0031 | In distribution | |
| 1834-0030 | In distribution | |
| 1834-0020 | In distribution | |
| 1834-0050 | In distribution | |
| 1834-0151 | In distribution | |
| 1834-0010 | In distribution | |
| 1834-0130 | In distribution | |
| 1834-0140 | In distribution | |
| 2832-1004 | In distribution | |
| 1834-0150 | In distribution | |
| 1834-0040 | In distribution | |
| 2832-2003 | In distribution | |
| 1834-0152 | In distribution | |
| 1834-0120 | In distribution | |
| 2832-2001 | 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 |
|---|---|
| K252454 | 2025-09-03 |
| K242868 | 2024-10-18 |
| K241482 | 2024-07-22 |
| K240591 | 2024-04-29 |
| K232595 | 2023-11-28 |
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.