Duraloc
DURALOC ACETABULAR CUP SYSTEM CONSTRAINED LINER 28mm ID 62/74mm OD
10manufacturers in China registered for this device type
18catalogue numbers in this listing
3510(k) clearances naming this product code
1recall
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 | Depuy Orthopaedics, Inc., 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, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | P960054 |
| Record published | 2015-09-24 |
| Record revised | 2026-04-13 (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, expiry date |
| Storage | Storage environment temperature -6.5 to 21 °C; Handling environment temperature 20 to 70 °F; Handling environment temperature -6.5 to 21 °C; Storage environment temperature 20 to 70 °F |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1241-26-527 | In distribution | |
| 1242-12-527 | In distribution | |
| 1241-22-527 | In distribution | |
| 1241-16-527 | In distribution | |
| 1242-18-527 | In distribution | |
| 1241-20-527 | In distribution | |
| 1241-10-527 | In distribution | |
| 1241-24-527 | In distribution | |
| 1242-24-527 | In distribution | |
| 1242-14-527 | In distribution | |
| 1241-12-527 | In distribution | |
| 1241-14-527 | In distribution | |
| 1241-08-527 | In distribution | |
| 1242-26-527 | In distribution | |
| 1242-20-527 | In distribution | |
| 1241-18-527 | In distribution | |
| 1242-22-527 | In distribution | |
| 1242-16-527 | 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 |
|---|---|
| K071059 | 2007-11-09 |
| K071117 | 2007-05-18 |
| K052079 | 2005-10-21 |
Recalls
1 of these is 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 | Closed |
|---|---|---|---|---|---|
| 2012-08-22 | Class II | Labeling Change Control | Orthopaedics, Inc. (DePuy) is issuing a voluntary recall of four lots of the S-ROM” liner because the Carton label has an Incorrect Color Code Series Designation. We have received one complaint regarding this issue. | 12 liners | 2013-10-09 |
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.