Series II
15 catalogue numbers from 2041-N-332, listed by Howmedica Osteonics Corp, United States, under Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer. 10 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Jiangsu (5), Shanghai (2), Zhejiang (2). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Xian Airfoil Technology Co., Ltd. | Xian | Shaanxi | Contract manufacturer | 8 |
| Lincotek (Wuxi) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 7 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
Record
| Listed by | Howmedica Osteonics Corp, United States |
|---|---|
| FDA product code | KWZ |
| Device type | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3310 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Manufacturer |
| 510(k) | K063552 |
| Record published | 2015-09-24 |
| Record revised | 2018-07-06 (version 3) |
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, manufacturing date, serial number |
| Sizes | Lumen/inner diameter 28 to 32 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2041-N-332 | Lumen/Inner Diameter 32.0 mm | In distribution |
| 2041-N-328 | Offset: 4.0 Millimeter | In distribution |
| 2041-N-428 | Offset: 4.0 Millimeter | In distribution |
| 2041-H-632 | Lumen/Inner Diameter 32.0 mm | In distribution |
| 2041-N-432 | Lumen/Inner Diameter 32.0 mm | In distribution |
| 2041-N-532 | Lumen/Inner Diameter 32.0 mm | In distribution |
| 2041-H-328 | Lumen/Inner Diameter 28.0 mm | In distribution |
| 2041-H-228 | Lumen/Inner Diameter 28.0 mm | In distribution |
| 2041-H-428 | Lumen/Inner Diameter 28.0 mm | In distribution |
| 2041-H-332 | Lumen/Inner Diameter 32.0 mm | In distribution |
| 2041-N-228 | Lumen/Inner Diameter 28.0 mm | In distribution |
| 2041-H-532 | Offset: 4.0 Millimeter | In distribution |
| 2041-H-432 | Offset: 4.0 Millimeter | In distribution |
| C-M108-7-600 | Lumen/Inner Diameter 28.0 mm | In distribution |
| 2041-N-632 | Lumen/Inner Diameter 32.0 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DJO Surgical | Encore Medical, L.P. | 159 |
| Instrument | Howmedica Osteonics Corp | 139 |
| ZMR® | Zimmer, Inc. | 103 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | Zimmer, Inc. | 69 |
| Arcos Modular Revision System | Biomet Orthopedics | 66 |
| Pinnacle | Depuy Orthopaedics, Inc. | 52 |
| System 12 | Howmedica Osteonics Corp | 47 |
| Restoration | Howmedica Osteonics Corp | 46 |
| Redapt | Smith & Nephew, Inc. | 43 |
| R3 | Smith & Nephew, Inc. | 41 |
| Trident | Howmedica Osteonics Corp | 38 |
| Arcos Modular Revision Hip System | Biomet Orthopedics | 37 |
Showing 12 of 165. All products under Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K063445 | 2007-03-08 |
| K063550 | 2007-03-08 |
| K063552 | 2007-03-08 |
| K061654 | 2006-07-07 |
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 |
|---|---|---|---|---|
| 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 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P960054 | 1997-06-19 | S-ROM POLY-DIAL CONSTRAINED LINER | Depuy, A Johnson & Johnson Co. |
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.