Kinos Axiom
Anatomic Flat-Cut Talar Implant, Size 4, Right with Tidal Technology
1manufacturer
96catalogue numbers in this listing
5510(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 | 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) | K192778 |
| Record published | 2020-10-12 |
| Record revised | 2023-11-02 (version 6) |
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 |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2023-05-08 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3801.1106 | In distribution | |
| 1801.1140 | In distribution | |
| 3801-1510 | In distribution | |
| 3801-2408 | In distribution | |
| 3801-1410 | In distribution | |
| 3801-2510 | In distribution | |
| 3801-2406 | In distribution | |
| 1801.2141 | In distribution | |
| 1801.2130 | In distribution | |
| 3801.1108 | In distribution | |
| 3801-1210 | In distribution | |
| 1801.2140 | In distribution | |
| 3801-1412 | In distribution | |
| 3801-1308 | In distribution | |
| 2831-3003 | In distribution | |
| 3801-2410 | In distribution | |
| 2801.1001 | In distribution | |
| 3801-2306 | In distribution | |
| 2801.2001 | In distribution | |
| 3801-2212 | In distribution | |
| 3801-2310 | In distribution | |
| 5801.0005 | In distribution | |
| 3801-1312 | In distribution | |
| 2831-4004 | In distribution | |
| 3801-2106 | In distribution | |
| 5801.0002 | In distribution | |
| 3801-2112 | In distribution | |
| 2831-4003 | In distribution | |
| 1801.1120 | In distribution | |
| 5801.0009 | In distribution | |
| 3801-1306 | In distribution | |
| 2831-4001 | In distribution | |
| 3801-2206 | In distribution | |
| 1801.2131 | In distribution | |
| 2831-3001 | In distribution | |
| 5801.0008 | In distribution | |
| 2831.3005 | In distribution | |
| 5801.0011 | In distribution | |
| 3801-1208 | In distribution | |
| 3801-1512 | In distribution | |
| 1801.1141 | In distribution | |
| 5801.0006 | In distribution | |
| 2831.4005 | In distribution | |
| 3801-1408 | In distribution | |
| 3801-2506 | In distribution | |
| 2831-3002 | In distribution | |
| 2801.1003 | In distribution | |
| 1801.1150 | In distribution | |
| 5801.0007 | In distribution | |
| 3801-1112 | In distribution | |
| 5801.0003 | In distribution | |
| 2831-4002 | In distribution | |
| 1801.1151 | In distribution | |
| 3801-1506 | In distribution | |
| 3801-2412 | In distribution | |
| 3801-2108 | In distribution | |
| 1801.2110 | In distribution | |
| 1801.2150 | In distribution | |
| 1801.1130 | In distribution | |
| 2801.2002 | In distribution | |
| 3801-1110 | In distribution | |
| 5801.0001 | In distribution | |
| 1801.1131 | In distribution | |
| 3801-1310 | In distribution | |
| 3801-2312 | In distribution | |
| 3801-1212 | In distribution | |
| 3801-2512 | In distribution | |
| 2801.1002 | In distribution | |
| 3801-2210 | In distribution | |
| 3801-1508 | In distribution | |
| 3801-2110 | In distribution | |
| 3801-2208 | In distribution | |
| 3801-2308 | In distribution | |
| 3801-1206 | In distribution | |
| 2801.2003 | In distribution | |
| 2801.2004 | In distribution | |
| 1801.1110 | In distribution | |
| 2801.1004 | In distribution | |
| 3801-2508 | In distribution | |
| 3801-1406 | In distribution | |
| 5801.0010 | In distribution | |
| 1801.2120 | In distribution | |
| 1801.2151 | In distribution | |
| 2831-3004 | In distribution | |
| 2831.0213 | Withdrawn | |
| 2831.0214 | Withdrawn | |
| 2831.0212 | Withdrawn | |
| 2831.0211 | Withdrawn | |
| 2831.0215 | Withdrawn | |
| 2831.0111 | Withdrawn | |
| 2801.1005 | Withdrawn | |
| 2831.0115 | Withdrawn | |
| 2801.2005 | Withdrawn | |
| 2831.0114 | Withdrawn | |
| 2831.0112 | Withdrawn | |
| 2831.0113 | Withdrawn |
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.