Triathlon
23 catalogue numbers from 5630-G-422-E, listed by Howmedica Osteonics Corp, United States, under Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer. 7 manufacturers in China are registered for this product code.
7manufacturers in China registered for this device type
23catalogue numbers in this listing
4510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (2), Zhejiang (2). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| 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 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
Record
| Listed by | Howmedica Osteonics Corp, United States |
|---|---|
| FDA product code | KRR |
| Device type | Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3540 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer |
| 510(k) | K071881 |
| Record published | 2019-01-22 |
| Record revised | 2025-04-04 (version 6) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5630-G-422-E | Side: Right Medial/Left Lateral | In distribution |
| 5630-G-408 | Side: Left Medial/Right Lateral | In distribution |
| 5630-G-208-E | Thickness: 8.0 Millimeter | In distribution |
| 5630-G-510-E | Side: Left Medial/Right Lateral | In distribution |
| 5630-G-328 | Size: 3 | In distribution |
| 5630-G-310 | Side: Left Medial/Right Lateral | In distribution |
| 5630-G-208 | Side: Left Medial/Right Lateral | In distribution |
| 5630-G-628 | Side: Right Medial/Left Lateral | In distribution |
| 5630-G-309 | Side: Left Medial/Right Lateral | In distribution |
| 5630-G-312 | Size: 3 | In distribution |
| 5630-G-229-E | Thickness: 9.0 Millimeter | In distribution |
| 5630-G-108-E | Size: 1 | In distribution |
| 5630-G-520 | Side: Right Medial/Left Lateral | In distribution |
| 5550-L-278 | Type: Symetric | In distribution |
| 5630-G-412 | Size: 4 | In distribution |
| 5630-G-310-E | Thickness: 10.0 Millimeter | In distribution |
| 5620-B-302 | Size: 3 | In distribution |
| 5630-G-222 | Size: 2 | In distribution |
| 5630-G-422 | Size: 4 | In distribution |
| 5610-F-301 | Size: 3 | In distribution |
| 5630-G-129-E | Size: 1 | In distribution |
| 5610-F-402 | Size: 4 | In distribution |
| 5620-B-201 | Size: 2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Arthrex® | Arthrex, Inc. | 103 |
| Restoris | Mako Surgical Corp. | 76 |
| Prelude Patello-Femoral System | Biomet Orthopedics | 61 |
| Prelude PF | Biomet Orthopedics | 59 |
| KneeTec PFJ | Corin Limited | 49 |
| HemiCAP® | Arthrosurface, Inc. | 48 |
| Instrument | Howmedica Osteonics Corp | 48 |
| Prelude PF | Biomet Sports Medicine | 21 |
| WaveKahuna™ | Arthrosurface, Inc. | 16 |
| HemiCAPWAVE® | Arthrosurface, Inc. | 16 |
| Sigma | Depuy (Ireland) | 16 |
| Restoris Esyntial | Mako Surgical Corp. | 14 |
Showing 12 of 47. All products under Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K051948 | 2005-10-21 |
| K041160 | 2004-05-27 |
| K020841 | 2002-04-11 |
| K010100 | 2001-04-06 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Howmedica Osteonics Corp | 510(k) number | 2008-11-25 | Not classified | Labeling mix-ups | Label mix-up: Stryker Orthopaedics became aware of a lot for lot mix up between Triathlon PKR Insert X3 #1 LM/RL 8mm, 5630-G-108 lot code NXDMEE and Triathlon PKR Insert X3 #1 RM/LL- 12 mm 5630-G-122 lot code M8JMEE. | 8 mm – 1 unit; 12 mm – 8 units. | 2010-08-30 |
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.