P.C.A.
Modular Revision Insert
21manufacturers in China registered for this device type
70catalogue numbers in this listing
32510(k) clearances naming this product code
40recalls on this code
Who Else Makes It
Concentrated in Jiangsu (10), Shanghai (4), Beijing (3). 13 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 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Stryker Orthmed (Changzhou) Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| b-ONE Medical (Beijing) Co., Ltd. | Beijing | Beijing | Contract manufacturer | 7 |
| Changzhou Wastonortho Medical Appliance Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 5 |
Showing 12 of 21. All 21 manufacturers in China registered for Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Record
| Listed by | Howmedica Osteonics Corp, United States |
|---|---|
| FDA product code | JWH |
| Device type | Prosthesis, Knee, Patellofemorotibial, 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) | K894403 |
| Record published | 2015-09-24 |
| Record revised | 2021-02-05 (version 4) |
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 |
|---|---|---|
| 6728-1-619 | Side: LEFT | In distribution |
| 6728-1-716 | Side: RIGHT | In distribution |
| 6728-1-611 | Side: LEFT | In distribution |
| 2642-5-131 | Thickness: 31.0 Millimeter | In distribution |
| 6728-2-611 | Side: LEFT | In distribution |
| 6728-2-625 | Size: MED | In distribution |
| 6728-1-722 | Side: RIGHT | In distribution |
| 6728-4-616 | Size: LGE | In distribution |
| 6728-2-613 | Size: MED | In distribution |
| 6728-2-722 | Thickness: 22.0 Millimeter | In distribution |
| 6728-1-711 | Thickness: 11.0 Millimeter | In distribution |
| 6728-4-609 | Side: LEFT | In distribution |
| 6728-2-716 | Thickness: 16.0 Millimeter | In distribution |
| 6728-2-616 | Thickness: 16.0 Millimeter | In distribution |
| 6728-4-719 | Size: LGE | In distribution |
| 2642-1-109 | Size: SM | In distribution |
| 6728-2-719 | Size: MED | In distribution |
| 2642-1-113 | Thickness: 13.0 Millimeter | In distribution |
| 2642-3-125 | Size: MED | In distribution |
| 2642-3-119 | Size: MED | In distribution |
| 6728-4-722 | Thickness: 22.0 Millimeter | In distribution |
| 6728-2-711 | Size: MED | In distribution |
| 2642-5-125 | Thickness: 25.0 Millimeter | In distribution |
| 6728-4-622 | Thickness: 22.0 Millimeter | In distribution |
| 2642-5-116 | Thickness: 16.0 Millimeter | In distribution |
| 2642-5-113 | Size: LGE | In distribution |
| 6728-1-616 | Side: LEFT | In distribution |
| 6728-4-709 | Side: RIGHT | In distribution |
| 2642-1-119 | Thickness: 19.0 Millimeter | In distribution |
| 6728-1-625 | Size: SM | In distribution |
| 2642-3-113 | Size: MED | In distribution |
| 6728-2-725 | Side: RIGHT | In distribution |
| 6728-4-611 | Size: LGE | In distribution |
| 6728-1-709 | Side: RIGHT | In distribution |
| 6728-1-725 | Thickness: 25.0 Millimeter | In distribution |
| 6728-2-709 | Side: RIGHT | In distribution |
| 6728-1-609 | Thickness: 9.0 Millimeter | In distribution |
| 2642-5-109 | Size: LGE | In distribution |
| 2642-3-131 | Size: MED | In distribution |
| 6728-1-719 | Size: SM | In distribution |
| 6728-2-609 | Side: LEFT | In distribution |
| 6728-4-716 | Side: RIGHT | In distribution |
| 2642-3-122 | Thickness: 22.0 Millimeter | In distribution |
| 6728-4-625 | Thickness: 25.0 Millimeter | In distribution |
| 2642-1-125 | Thickness: 25.0 Millimeter | In distribution |
| 2642-1-111 | Size: SM | In distribution |
| 6728-4-711 | Size: LGE | In distribution |
| 2642-1-116 | Size: SM | In distribution |
| 2642-3-128 | Size: MED | In distribution |
| 2642-3-111 | Size: MED | In distribution |
| 6728-1-613 | Size: SM | In distribution |
| 6728-4-613 | Side: LEFT | In distribution |
| 2642-5-111 | Thickness: 11.0 Millimeter | In distribution |
| 6728-2-622 | Side: LEFT | In distribution |
| 6728-1-622 | Size: SM | In distribution |
| 2642-1-122 | Size: SM | In distribution |
| 6728-2-619 | Size: MED | In distribution |
| 2642-1-128 | Size: SM | In distribution |
| 2642-1-131 | Size: SM | In distribution |
| 2642-3-109 | Thickness: 9.0 Millimeter | In distribution |
| 6728-4-725 | Side: RIGHT | In distribution |
| 6728-4-713 | Thickness: 13.0 Millimeter | In distribution |
| 6728-2-713 | Size: MED | In distribution |
| 6728-1-713 | Thickness: 13.0 Millimeter | In distribution |
| 6728-4-619 | Thickness: 19.0 Millimeter | In distribution |
| 6728-1-940 | Size: SM | In distribution |
| 2642-5-128 | Thickness: 28.0 Millimeter | In distribution |
| 2642-5-122 | Thickness: 22.0 Millimeter | In distribution |
| 2642-5-119 | Thickness: 19.0 Millimeter | In distribution |
| 2642-3-116 | Size: MED | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prophecy® | Microport Orthopedics Inc. | 4,423 |
| Exult Knee Replacement System | Corentec Co., Ltd. | 1,770 |
| Freedom | Maxx Orthopedics Inc. | 1,693 |
| Legion | Smith & Nephew, Inc. | 1,534 |
| MyKnee | Medacta International SA | 1,466 |
| Journey | Smith & Nephew, Inc. | 1,339 |
| Persona® | Zimmer, Inc. | 1,254 |
| DJO Surgical | Encore Medical, L.P. | 1,131 |
| U2 Total Knee System | United Orthopedic Corp. | 1,078 |
| CKS Plus | Shalby Advanced Technologies, Inc. | 1,024 |
| Lospa Modular Knee System | Corentec Co., Ltd. | 1,020 |
| Natural-Knee® | Zimmer, Inc. | 980 |
Showing 12 of 1,175. All products under Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K123166 | 2013-02-14 |
| K072221 | 2007-10-15 |
| K071991 | 2007-08-15 |
| K070095 | 2007-06-01 |
| K063423 | 2007-01-22 |
| K062037 | 2006-08-03 |
| K051977 | 2005-10-12 |
| K051146 | 2005-07-13 |
| K050539 | 2005-03-29 |
| K042343 | 2005-02-09 |
| K042993 | 2005-01-12 |
| K042883 | 2004-11-23 |
| K041591 | 2004-09-23 |
| K040964 | 2004-05-28 |
| K040267 | 2004-05-05 |
| K033342 | 2004-01-15 |
| K032829 | 2003-12-10 |
| K030978 | 2003-11-20 |
| K032479 | 2003-09-04 |
| K031729 | 2003-09-02 |
| K023724 | 2003-02-03 |
| K020703 | 2002-11-13 |
| K021451 | 2002-10-18 |
| K020830 | 2002-06-06 |
| K012776 | 2001-11-16 |
| K012172 | 2001-10-10 |
| K011643 | 2001-06-28 |
| K001147 | 2001-02-15 |
| K000091 | 2000-03-10 |
| K994128 | 2000-03-06 |
| K993692 | 1999-12-02 |
| K991461 | 1999-05-17 |
Recalls Naming This Product
4 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 |
|---|---|---|---|---|---|
| Howmedica Osteonics Corp | 510(k) number | 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. |
| Howmedica Osteonics Corp | 510(k) number | 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. |
| Howmedica Osteonics Corp | 510(k) number | 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. |
| Howmedica Osteonics Corp | 510(k) number | 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. |
Recalls
35 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 |
|---|---|---|---|---|
| 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 |
| 2024-09-04 | Class II | Process control | Anterior locking tabs on the Triathlon Universal Baseplate are out of specification which may prevent engagement of either of the two locking tabs with the locking wire of the tibial insert. | 16 units |
| 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | 107 units US; 176 units OUS |
| 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | 4 units |
| 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | |
| 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | |
| 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | 76 units US; |
| 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | |
| 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | |
| 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | |
| 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | |
| 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | |
| 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | 143 units US; 290 units OUS |
| 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | |
| 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | |
| 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | 16 units US; 56 units OUS |
| 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | |
| 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | |
| 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | |
| 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | 36 units US |
| 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | |
| 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | 269 units US; 307 units OUS |
| 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | 137 units US; 326 units OUS |
| 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | 1 units US; 146 units oUS |
| 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | 9 units US |
| 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | 5 units US |
| 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | 52 units US; 20 units OUS |
| 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | |
| 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | 70 units US |
| 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | 61 units US; 46 units OUS |
| 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | 4 units US |
| 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | 192 units US |
| 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | |
| 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | |
| 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. | |
| 2023-12-01 | Class II | Nonconforming Material/Component | Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties. |
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.