Infinity™ Adaptis™
Tibial Tray
1manufacturer
15catalogue numbers in this listing
9recalls on this 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 | Wright Medical Technology, 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, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K123954 |
| Record published | 2020-04-14 |
| Record revised | 2023-01-20 (version 3) |
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, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 33680071 | Size 1 | In distribution |
| 33680072 | Size 2 | In distribution |
| 33680143 | In distribution | |
| 33680004 | Size: 4 | In distribution |
| 33680001 | Size: 1 | In distribution |
| 33680005 | Size: 5 | In distribution |
| 33680073 | Size 3 | In distribution |
| 33680015 | 5 Long | In distribution |
| 33680003 | Size: 3 | In distribution |
| 33680013 | 3 Long | In distribution |
| 33680014 | 4 Long | In distribution |
| 33680075 | Flat Cut | In distribution |
| 9914PK02 | SZ 4-6 | In distribution |
| 9914PK02 | SZ 1-3 | In distribution |
| 33680074 | Flat Cut | 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
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Wright Medical Technology, Inc. | 510(k) number | 2024-03-06 | Class II | Process change control | Stryker has identified an issue that impacts specific lots of Infinity” Resection Guide Adjustment Blocks. The parts within these three lots were found to have been missing an internal screw in the finished instrument assembly. The missing | 47 units |
| Wright Medical Technology, Inc. | 510(k) number | 2023-06-13 | Class II | Process control | The devices were manufactured with the pin sleeve holes too narrow, which does not allow the pin sleeves to pass through the pin sleeve holes, thereby preventing pin placement through the pin holes. | 106 devices |
Recalls
7 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2022-09-30 | Class II | Device Design | The tibial tray lock detail is oversized (larger than specification). | 1 unit | 2026-08-21 |
| 2022-09-30 | Class II | Device Design | The tibial tray lock detail is oversized (larger than specification). | 1 unit | 2026-08-21 |
| 2022-06-02 | Class II | Nonconforming Material/Component | The instrument is incorrectly color coded. | 35 units | |
| 2021-11-04 | Class II | Nonconforming Material/Component | The package contents and package labeling do not match. | 2 units | 2023-01-06 |
| 2021-11-04 | Class II | Nonconforming Material/Component | The package contents and package labeling do not match. | 0 (2 Quarantined) | 2023-01-06 |
| 2020-04-09 | Class II | Nonconforming Material/Component | One lot of INBONE Tibial Trays is missing the plasma coating. | 22 units | 2020-11-02 |
| 2016-11-08 | Class II | Process control | The firm discovered a lack of adequate documentation confirming sterility on certain products. | 65 units | 2020-11-03 |
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.