Instrument
Specialty Triathlon TS Femoral Posterior Augment Trial Size 1 10MM
6manufacturers in China registered for this device type
52catalogue numbers in this listing
2510(k) clearances naming this product code
2recalls on this code
Who Else Makes It
Concentrated in Zhejiang (2), Jiangsu (2), Shanghai (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Turnxon Precision Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 17 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
Record
| Listed by | Howmedica Osteonics Corp, United States |
|---|---|
| FDA product code | HSX |
| Device type | Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3520 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer |
| Record published | 2017-11-29 |
| Record revised | 2022-03-22 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Distribution end date | 2021-06-22 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| I-K2131PT40 | Type: Asymetric | In distribution |
| I-K4231FS10 | In distribution | |
| 6543-1-707 | Size: 7 | In distribution |
| I-K34960713 | Size: 7 | In distribution |
| 5650-2-603 | Side: Left Medial/Right Lateral | In distribution |
| I-K4023DA07 | Offset: 10.0 Millimeter | In distribution |
| 5538-T-209 | Size: 2 | In distribution |
| I-K2131PT38 | Diameter: 38.0 Millimeter | In distribution |
| 5537-T-522 | Size: 5 | In distribution |
| I-K39600617 | Size: 6 | In distribution |
| I-K39600217 | Size: 2 | In distribution |
| 5538-T-311 | Thickness: 11.0 Millimeter | In distribution |
| I-K34960609 | Type: CR | In distribution |
| 6541-1-704E | Size: 4 | In distribution |
| I-K3331PT39 | Diameter: 39.0 Millimeter | In distribution |
| I-K2546JM80 | In distribution | |
| I-K4023PA01 | Size: 1 | In distribution |
| 6543-2-600 | In distribution | |
| 6541-2-604 | Size: 4 | In distribution |
| I-K34960716 | Thickness: 16.0 Millimeter | In distribution |
| 5538-T-511 | Size: 5 | In distribution |
| I-K39600518 | Thickness: 18.0 Millimeter | In distribution |
| I-K39600417 | Size: 4 | In distribution |
| 5630-T-510 | Thickness: 10.0 Millimeter | In distribution |
| I-K2278FE13 | Thickness: 13.0 Millimeter | In distribution |
| I-K2084TS49 | In distribution | |
| 5630-T-508 | Thickness: 8.0 Millimeter | In distribution |
| 5537-T-109 | Size: 1 | In distribution |
| 5630-T-209 | Thickness: 9.0 Millimeter | In distribution |
| 5512-T-201 | Type: TS | In distribution |
| I-K34960811 | Thickness: 11.0 Millimeter | In distribution |
| 5538-T-531 | Thickness: 31.0 Millimeter | In distribution |
| I-K2546JM70 | In distribution | |
| 6543-1-736 | Size: 6 | In distribution |
| I-K4231GBS0 | In distribution | |
| 5650-2-616 | Size: 6 | In distribution |
| I-K3331PT33 | Diameter: 33.0 Millimeter | In distribution |
| I-K2131PT35 | Thickness: 10.0 Millimeter | In distribution |
| 5538-T-416 | Size: 4 | In distribution |
| I-K34960216 | Size: 2 | In distribution |
| 6541-2-606 | Size: 6 | In distribution |
| I-K34960516 | Type: CR | In distribution |
| I-K2131PT29 | Type: Asymetric | In distribution |
| 5538-T-125 | Thickness: 25.0 Millimeter | In distribution |
| 5538-T-431 | Size: 4 | In distribution |
| I-K4197TT04 | In distribution | |
| I-K34960711 | Type: CR | In distribution |
| 5650-2-613 | Size: 3 | In distribution |
| I-K2535BG02 | Size: 2 | In distribution |
| I-K3281KP46 | In distribution | |
| I-K4023DA14 | Size: 6 | In distribution |
| I-K3834CG1L | Type: TS | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Journey | Smith & Nephew, Inc. | 517 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | Ortho Development Corp. | 303 |
| BKS® Uni | Ortho Development Corp. | 240 |
| LinkSymphoKnee | Waldemar Link GmbH & Co. KG | 210 |
| Moto Partial Knee System | Medacta International SA | 205 |
| Arthrex® | Arthrex, Inc. | 199 |
| Stride | Smith & Nephew, Inc. | 190 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | Zimmer, Inc. | 175 |
| ZUK | Smith & Nephew, Inc. | 161 |
| Tahoe Uni Knee System | Shalby Advanced Technologies, Inc. | 134 |
| Moto Partial Knee System – Medial | Medacta International SA | 132 |
| Journey II | Smith & Nephew, Inc. | 119 |
Showing 12 of 171. All products under Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K033769 | 2004-02-13 |
| K992287 | 1999-11-16 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Howmedica Osteonics Corp | UDI-DI | 2021-03-05 | Class II | Under Investigation by firm | The posterior condyle of the Specialty Triathlon TS Trial Cutting Guide(s), sizes 1 through 8, (Left and Right) has the potential to fracture at the augment cut slot. This can occur in the Trial Cutting Guide packaging during transport or d | 113 components | 2024-05-10 |
Recalls
2 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 |
|---|---|---|---|---|
| 2023-03-10 | Class II | Process change control | Certain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking | 102 units |
| 2023-03-10 | Class II | Process change control | Ccertain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking | 52 units |
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.