R3
R3 Constrained Acetabular Liner 66-70MM
10manufacturers in China registered for this device type
41catalogue numbers in this listing
6510(k) clearances naming this product code
13recalls on this 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 | Smith & Nephew, 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, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K162641 |
| Record published | 2018-01-02 |
| Record revised | 2026-06-11 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| 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 |
|---|---|---|
| XH000476-1 | In distribution | |
| XH000481-2 | In distribution | |
| XH000492-1 | In distribution | |
| XH000479-1 | In distribution | |
| 71339156 | In distribution | |
| XH000504-1 | In distribution | |
| XH000498-1 | In distribution | |
| XH000502-2 | In distribution | |
| 71339150 | In distribution | |
| 71339160 | In distribution | |
| XH000501-1 | In distribution | |
| 71339162 | In distribution | |
| 71339148 | In distribution | |
| XH000500-2 | In distribution | |
| XH000499-2 | In distribution | |
| XH000500-1 | In distribution | |
| XH000490-1 | In distribution | |
| XH000504-2 | In distribution | |
| 71339164 | In distribution | |
| XH000463-1 | In distribution | |
| XH000454-1 | In distribution | |
| XH000497-1 | In distribution | |
| XH000482-1 | In distribution | |
| XH000499-1 | In distribution | |
| XH000457-1 | In distribution | |
| XH000477-2 | In distribution | |
| XH000475-2 | In distribution | |
| XH000480-1 | In distribution | |
| 71339158 | In distribution | |
| XH000506-1 | In distribution | |
| XH000503-1 | In distribution | |
| XH000491-1 | In distribution | |
| XH000477-1 | In distribution | |
| 71339166 | In distribution | |
| XH000502-1 | In distribution | |
| 71339154 | In distribution | |
| XH000481-1 | In distribution | |
| XH000483-1 | In distribution | |
| XH000475-1 | In distribution | |
| XH000505-1 | In distribution | |
| 71339152 | 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 |
| Trident | Howmedica Osteonics Corp | 38 |
| Arcos Modular Revision Hip System | Biomet Orthopedics | 37 |
| G7® | Biomet Orthopedics | 37 |
Showing 12 of 165. All products under Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K162641 | 2017-06-19 |
| K122139 | 2012-10-16 |
| K111635 | 2011-09-09 |
| K083566 | 2009-03-03 |
| K033442 | 2003-11-26 |
| K021803 | 2002-12-19 |
Recalls Naming This Product
13 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 | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Smith & Nephew, Inc. | 510(k) number | 2015-05-06 | Class II | Process change control | The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allow the locking ring to engage into the R3 shell. | 17 units | 2022-04-01 |
| Smith & Nephew, Inc. | 510(k) number | 2015-05-06 | Class II | Process change control | The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allow the locking ring to engage into the R3 shell. | 0 | 2022-04-01 |
| Smith & Nephew, Inc. | 510(k) number | 2015-05-06 | Class II | Process change control | The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allow the locking ring to engage into the R3 shell. | 12 units | 2022-04-01 |
| Smith & Nephew, Inc. | 510(k) number | 2015-05-06 | Class II | Process change control | The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allow the locking ring to engage into the R3 shell. | 40 units | 2022-04-01 |
| Smith & Nephew, Inc. | 510(k) number | 2015-05-06 | Class II | Process change control | The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allow the locking ring to engage into the R3 shell. | 32 units | 2022-04-01 |
| Smith & Nephew, Inc. | 510(k) number | 2010-08-13 | Not classified | Other | The firm received reports of a femoral head popping out of the liner intraoperatively. | 118 units | 2011-09-21 |
| Smith & Nephew, Inc. | 510(k) number | 2010-08-13 | Not classified | Other | The firm received reports of a femoral head popping out of the liner intraoperatively. | 91 units | 2011-09-21 |
| Smith & Nephew, Inc. | 510(k) number | 2010-08-13 | Not classified | Other | The firm received reports of a femoral head popping out of the liner intraoperatively. | 89 units | 2011-09-21 |
| Smith & Nephew, Inc. | 510(k) number | 2010-08-13 | Not classified | Other | The firm received reports of a femoral head popping out of the liner intraoperatively. | 82 units | 2011-09-21 |
| Smith & Nephew, Inc. | 510(k) number | 2010-08-13 | Not classified | Other | The firm received reports of a femoral head popping out of the liner intraoperatively. | 91 units | 2011-09-21 |
| Smith & Nephew, Inc. | 510(k) number | 2010-08-13 | Not classified | Other | The firm received reports of a femoral head popping out of the liner intraoperatively. | 84 units | 2011-09-21 |
| Smith & Nephew, Inc. | 510(k) number | 2010-08-13 | Not classified | Other | The firm received reports of a femoral head popping out of the liner intraoperatively. | 82 units | 2011-09-21 |
| Smith & Nephew, Inc. | 510(k) number | 2010-08-13 | Not classified | Other | The firm received reports of a femoral head popping out of the liner intraoperatively. | 79 units | 2011-09-21 |
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.