Specialty Triathlon TS Cutting Guide Size 3
Catalogue number I-K4275CG03, listed by Howmedica Osteonics Corp, United States, under Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer. 12 manufacturers in China are registered for this product code.
12manufacturers in China registered for this device type
1catalogue number
9510(k) clearances naming this product code
26recalls on this code
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (3), Zhejiang (2). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| 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 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Howmedica Osteonics Corp, United States |
|---|---|
| FDA product code | MBH |
| Device type | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3565 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer |
| Record published | 2022-02-21 |
| Record revised | 2023-05-03 (version 2) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| I-K4275CG03 | Size: 3 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prophecy | Microport Orthopedics Inc. | 4,272 |
| Triathlon | Howmedica Osteonics Corp | 712 |
| Instrument | Howmedica Osteonics Corp | 709 |
| Persona® Vivacit-E® | Zimmer, Inc. | 499 |
| Arthrex® | Arthrex, Inc. | 494 |
| Persona® | Zimmer, Inc. | 441 |
| Legion | Smith & Nephew, Inc. | 397 |
| U2 Total Knee System | United Orthopedic Corp. | 286 |
| Attune | Depuy (Ireland) | 234 |
| DJO Surgical | Encore Medical, L.P. | 191 |
| Vanguard XP Instrumentation | Biomet Orthopedics | 150 |
| Truliant® | Exactech, Inc. | 142 |
Showing 12 of 948. All products under Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K200782 | 2020-05-13 |
| K070883 | 2007-05-11 |
| K061521 | 2006-08-11 |
| K051380 | 2005-08-30 |
| K043374 | 2005-02-16 |
| K033971 | 2004-05-28 |
| K033972 | 2004-04-12 |
| K032163 | 2003-09-12 |
| K032418 | 2003-09-11 |
Recalls
1 of these is Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. 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 |
|---|---|---|---|---|---|
| 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 | |
| 2026-05-19 | Class II | Under Investigation by firm | Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon Universal Baseplate Size 4 (lot TYX7OB), is contained in pa | 7 units | |
| 2026-05-19 | Class II | Under Investigation by firm | Stryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate Size 4 (lot TYX7OB), and Triathlon Universal Baseplate Size 4 (lot TYX7OB), is contained in pa | 7 units | |
| 2024-02-06 | Class II | Packaging | Potential packaging breaches of inner blister and outer sterile blister. | 39 units (US); 10 units (OUS) | |
| 2024-02-06 | Class II | Packaging | Potential packaging breaches of inner blister and outer sterile blister. | 143 units (US) | |
| 2024-02-06 | Class II | Packaging | Potential packaging breaches of inner blister and outer sterile blister. | 37 units (US); 10 units (OUS) | |
| 2024-02-06 | Class II | Packaging | Potential packaging breaches of inner blister and outer sterile blister. | 24 units (US) | |
| 2024-02-06 | Class II | Packaging | Potential packaging breaches of inner blister and outer sterile blister. | 24 units (US) | |
| 2024-02-06 | Class II | Packaging | Potential packaging breaches of inner blister and outer sterile blister. | 24 units (US); 1 unit (OUS) | |
| 2024-02-06 | Class II | Packaging | Potential packaging breaches of inner blister and outer sterile blister. | 132 units (US); 26 units (OUS) | |
| 2024-02-06 | Class II | Packaging | Potential packaging breaches of inner blister and outer sterile blister. | 18 units (US); 5 units (OUS) | |
| 2023-04-13 | Class II | Under Investigation by firm | Mislabeled:Labeled Catalog Number: 5531-G-312-E, TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM, may contain Catalog Number: 5532-G-413-E, TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM, and vice versa | 24 units in total | |
| 2023-04-13 | Class II | Under Investigation by firm | Mislabeled:Labeled Catalog Number: 5531-G-312-E, TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM, may contain Catalog Number: 5532-G-413-E, TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM, and vice versa | 24 units in total | |
| 2021-02-10 | Class II | Under Investigation by firm | Stryker has discovered that the internal profile of the Triathlon Tritanium Tibial Component (Baseplate), size 4, is potentially oversized. Due to a manufacturing issue in Lot Number CTD44301, there may be a witness mark (taper) at the bott | 11 devices | 2023-05-30 |
| 2019-08-19 | Class II | Device Design | Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral component | 171 units | 2020-05-06 |
| 2019-08-19 | Class II | Device Design | Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral component | 153 units | 2020-05-06 |
| 2019-08-19 | Class II | Device Design | Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral component | 167 units | 2020-05-06 |
| 2019-08-19 | Class II | Device Design | Due to device overhang issue that protrudes beyond the medial periphery of the mating femoral component | 159 units | 2020-05-06 |
| 2018-01-30 | Class II | Under Investigation by firm | Customers may receive the incorrect size implant from what is labeled on the box. | 77 total products | 2020-05-07 |
| 2018-01-12 | Class II | Error in labeling | Firm became aware that the specific product/lot combinations referenced above may contain the incorrect size implant from what is labeled on the box. | 6 units of catalog 5521-B-400 | 2020-05-07 |
| 2016-08-01 | Class II | Nonconforming Material/Component | Upon failure of the press-fit, the clamping sub components and pins could disassociate from the Scorpio Patella Assembly Instrument. | 2,039 units | 2017-06-08 |
| 2016-06-23 | Class II | Process control | It was reported that the secondary locking mechanism, and its corresponding components, disassociated from the Specialty Triathlon Tibial Alignment Handle with Secondary Lock Assembly during surgery. Upon further investigation, it was disco | 47 units | 2018-08-01 |
| 2015-05-29 | Class II | Labeling mix-ups | Stryker has received a report which identified that a Triathlon Tibial Bearing Insert CS X3 Size #2 9mm (5531-G-209) was reported to be in a pack that was labelled as a CR insert (5530-G-209). | 10 units | 2016-09-26 |
| 2015-02-12 | Class II | Device Design | Potential for weld disassociation of the cross pin, which could lead to loose or disassociated trigger mechanism on the Distal Capture Assembly. | 2030 units | 2016-07-05 |
| 2012-11-08 | Class I | Device Design | With regards to ShapeMatch Cutting Guides using MRI Imaging, Stryker Orthopaedics has become aware that there are potential issues associated with internal processes for planning cases and producing ShapeMatch Cutting Guides. | 7868 units | 2021-01-11 |
| 2006-09-21 | Not classified | Process change control | Stryker Orthopaedics became aware that one lot of the Triathlon Primary Beaded PA Baseplate Size 5 may not have the Peri-Apatite coating. | 10 | 2009-01-09 |
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.