Mpact Constrained Liner
Constrained 10° PE liner Ø28/F
10manufacturers in China registered for this device type
12catalogue numbers in this listing
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 | Medacta International SA, Switzerland |
|---|---|
| FDA product code | KWZ |
| Device type | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3310 |
| Establishment | Specification developer, Repacker / relabeller, Private-label distributor, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K241461 |
| Record published | 2025-08-06 |
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, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 01.32.2244CL | In distribution | |
| 01.32.2848CL10A | In distribution | |
| 01.32.2241CL | In distribution | |
| 01.32.2244CL10A | In distribution | |
| 01.32.2852CL | In distribution | |
| 01.32.2852CL10A | In distribution | |
| 01.32.2848CL | In distribution | |
| 01.32.2241CL10A | In distribution | |
| 01.32.2856CL | In distribution | |
| 01.32.2860CL | In distribution | |
| 01.32.2856CL10A | In distribution | |
| 01.32.2860CL10A | 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
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.