Triathlon
33 catalogue numbers from 5630-G-110, listed by Howmedica Osteonics Corp, United States, under Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
33catalogue numbers in this listing
1510(k) clearance
3recalls on this code
Who Else Makes It
Concentrated in Jiangsu (2), Zhejiang (1). 3 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 |
Record
| Listed by | Howmedica Osteonics Corp, United States |
|---|---|
| FDA product code | NPJ |
| Device type | Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3560 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer |
| 510(k) | K071881 |
| Record published | 2015-09-24 |
| Record revised | 2025-03-21 (version 6) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5630-G-110 | Size: 1 | In distribution |
| 5630-G-212-E | Side: Left Medial/Right Lateral | In distribution |
| 5630-G-229 | Side: Right Medial/Left Lateral | In distribution |
| 5630-G-429 | Side: Right Medial/Left Lateral | In distribution |
| 5630-G-228-E | Side: Right Medial/Left Lateral | In distribution |
| 5630-G-120-E | Side: Right Medial/Left Lateral | In distribution |
| 5630-G-428 | Side: Right Medial/Left Lateral | In distribution |
| 5630-G-210-E | Side: Left Medial/Right Lateral | In distribution |
| 5610-F-101 | Size: 1 | In distribution |
| 5630-G-510 | Side: Left Medial/Right Lateral | In distribution |
| 5630-G-528-E | Size: 5 | In distribution |
| 5630-G-312-E | Thickness: 12.0 Millimeter | In distribution |
| 5630-G-329-E | Size: 3 | In distribution |
| 5610-F-502 | Size: 5 | In distribution |
| 5630-G-322 | Side: Right Medial/Left Lateral | In distribution |
| 5630-G-520-E | Thickness: 10.0 Millimeter | In distribution |
| 5550-L-360 | Thickness: 10.0 Millimeter | In distribution |
| 5610-F-102 | Size: 1 | In distribution |
| 5620-B-402 | Size: 4 | In distribution |
| 5630-G-308 | Side: Left Medial/Right Lateral | In distribution |
| 5630-G-220 | Size: 2 | In distribution |
| 5630-G-329 | Size: 3 | In distribution |
| 5610-F-601 | Size: 6 | In distribution |
| 5630-G-512 | Thickness: 12.0 Millimeter | In distribution |
| 5630-G-628-E | Size: 6 | In distribution |
| 5610-F-202 | Size: 2 | In distribution |
| 5630-G-328-E | Side: Right Medial/Left Lateral | In distribution |
| 5630-G-608-E | Side: Left Medial/Right Lateral | In distribution |
| 5630-G-228 | Size: 2 | In distribution |
| 5550-L-391 | Type: Symetric | In distribution |
| 5630-G-128 | Side: Right Medial/Left Lateral | In distribution |
| 5630-G-528 | Size: 5 | In distribution |
| 5630-G-612 | Size: 6 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Restoris | Mako Surgical Corp. | 101 |
| Sigma | Depuy (Ireland) | 64 |
| Instrument | Howmedica Osteonics Corp | 62 |
| Journey | Smith & Nephew, Inc. | 24 |
| iDuo® iPoly™ Insert Kit | ConforMIS, Inc. | 15 |
| Restoris Esyntial | Mako Surgical Corp. | 13 |
| Mako | Mako Surgical Corp. | 7 |
| Specialty Triathlon TS Trial Assessment Guide Size 8 Right | Howmedica Osteonics Corp | 6 |
| iDuo® Patella Trial | ConforMIS, Inc. | 4 |
| Unix | Howmedica Osteonics Corp | 3 |
| iDuo® Patella Sizer | ConforMIS, Inc. | 3 |
| iDuo® Patella | ConforMIS, Inc. | 2 |
Showing 12 of 21. All products under Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K052917 | 2005-12-27 |
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 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2026-07-30 | Not classified | Process change control | Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to | 12,156 US | |
| 2011-08-17 | Not classified | Other | Two National Joint Registries suggest that the EIUS Unicompartmental System is associated with a higher revision rate then the unicompartmental devices. | 26,648 units | 2014-03-26 |
| 2004-10-27 | Not classified | Other | The fatigue testing of the Triathlon PS Femoral Component does not consistently meet the requirements of the finite element analysis predicted load as delineated in the 510(k) submittal. | 386 UNITS | 2005-05-31 |
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.