Agility
Agility LP Total Ankle System Poly Insert Mismatch Size 5/4
1manufacturer
53catalogue 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 | Depuy Orthopaedics, 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 | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K053569 |
| Record published | 2015-09-24 |
| Record revised | 2022-06-10 (version 4) |
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 |
|---|---|---|
| 1404-04-000 | In distribution | |
| 1555-04-030 | In distribution | |
| 1404-04-050 | In distribution | |
| 1555-33-010 | In distribution | |
| 1555-06-030 | In distribution | |
| 1555-31-010 | In distribution | |
| 1555-05-030 | In distribution | |
| 1555-32-010 | In distribution | |
| 1404-32-010 | In distribution | |
| 1404-32-000 | In distribution | |
| 1404-02-000 | In distribution | |
| 1404-05-000 | In distribution | |
| 1555-34-000 | In distribution | |
| 1404-03-050 | In distribution | |
| 1555-36-010 | In distribution | |
| 1404-05-050 | In distribution | |
| 1404-35-050 | In distribution | |
| 1404-31-010 | In distribution | |
| 1555-03-030 | In distribution | |
| 1404-36-050 | In distribution | |
| 1555-35-010 | In distribution | |
| 1404-06-050 | In distribution | |
| 1404-35-010 | In distribution | |
| 1404-33-010 | In distribution | |
| 1555-34-010 | In distribution | |
| 1404-34-010 | In distribution | |
| 1555-31-000 | In distribution | |
| 1555-32-020 | In distribution | |
| 1404-34-000 | In distribution | |
| 1404-36-010 | In distribution | |
| 1555-35-020 | In distribution | |
| 1404-34-050 | In distribution | |
| 1555-33-020 | In distribution | |
| 1404-06-000 | In distribution | |
| 1404-36-000 | In distribution | |
| 1404-32-050 | In distribution | |
| 1404-01-000 | In distribution | |
| 1404-35-000 | In distribution | |
| 1555-36-000 | In distribution | |
| 1404-02-050 | In distribution | |
| 1555-35-000 | In distribution | |
| 1555-33-000 | In distribution | |
| 1555-32-000 | In distribution | |
| 1404-03-000 | In distribution | |
| 1404-01-050 | In distribution | |
| 1404-31-000 | In distribution | |
| 1555-02-030 | In distribution | |
| 1555-01-030 | In distribution | |
| 1555-36-020 | In distribution | |
| 1555-34-020 | In distribution | |
| 1404-33-000 | In distribution | |
| 1555-31-020 | In distribution | |
| 1404-33-050 | 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 |
|---|---|
| K122395 | 2012-10-31 |
| K053569 | 2006-03-31 |
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.