Kinos Aeros Instrumentation
Kinos Modular Stem Tray – Pilot Drill Caddy Lid
1manufacturer
39catalogue 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) | K242868 |
| Record published | 2025-05-01 |
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, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5871-1067 | In distribution | |
| 5871-4061 | In distribution | |
| 5871-9816 | In distribution | |
| 5871-9811 | In distribution | |
| 5871-9810 | In distribution | |
| 5871-9814 | In distribution | |
| 5871-4116 | In distribution | |
| 5871-1163 | In distribution | |
| 5871-9813 | In distribution | |
| 5871-1161 | In distribution | |
| 5871-1155 | In distribution | |
| 5871-1164 | In distribution | |
| 5871-4092 | In distribution | |
| 5831-0832 | In distribution | |
| 5871-4102 | In distribution | |
| 5871-1079 | In distribution | |
| 5871-9817 | In distribution | |
| 5871-4101 | In distribution | |
| 5871-1068 | In distribution | |
| 5871-4114 | In distribution | |
| 5871-0014 | In distribution | |
| 5871-0012 | In distribution | |
| 5871-4001 | In distribution | |
| 5871-4069 | In distribution | |
| 5871-1156 | In distribution | |
| 5871-1056 | In distribution | |
| 5871-9818 | In distribution | |
| 5871-9812 | In distribution | |
| 5871-4091 | In distribution | |
| 5871-9015 | In distribution | |
| 5871-1162 | In distribution | |
| 5871-9815 | In distribution | |
| 5871-1158 | In distribution | |
| 5871-0056 | In distribution | |
| 5871-9819 | In distribution | |
| 5871-1157 | In distribution | |
| 5871-0018 | In distribution | |
| 5871-0016 | In distribution | |
| 5871-4118 | 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.