Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
60 catalogue numbers from 65-7711-010-10, listed by Zimmer, Inc., United States, under Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate. 14 manufacturers in China are registered for this product code.
14manufacturers in China registered for this device type
60catalogue numbers in this listing
2510(k) clearances naming this product code
2recalls on this code
Who Else Makes It
Concentrated in Jiangsu (8), Shanghai (2), Zhejiang (2). 8 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 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| 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 |
| b-ONE Medical (Beijing) Co., Ltd. | Beijing | Beijing | 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 |
Showing 12 of 14. All 14 manufacturers in China registered for Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Record
| Listed by | Zimmer, Inc., United States |
|---|---|
| FDA product code | MEH |
| Device type | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3353 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K042337 |
| Record published | 2017-09-02 |
| Record revised | 2020-04-06 (version 5) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 65-7711-010-10 | 12/14 Neck Taper, Size 10 | In distribution |
| 65-7711-007-40 | 12/14 Neck Taper, Size 7.5 | In distribution |
| 7210-28-000 | 28 mm, Diameter | In distribution |
| 7712-04-60 | Size 4 | In distribution |
| 7712-12-60 | Size 12.5 | In distribution |
| 65-7711-009-20 | 12/14 Neck Taper, Size 9 | In distribution |
| 65-7711-006-00 | 12/14 Neck Taper, Size 6 | In distribution |
| 7205-05-032 | +5.0 mm Neck, 32 mm, Diameter | In distribution |
| 7205-00-032 | 32 mm, Diameter | In distribution |
| 65-7711-012-00 | 12/14 Neck Taper, Size 12.5 | In distribution |
| 7205-05-028 | +5.0 mm Neck, 28 mm, Diameter | In distribution |
| 7210-26-800 | 26 mm, Diameter | In distribution |
| 7205-10-026 | +10.0 mm Neck, 26 mm, Diameter | In distribution |
| 7210-22-350 | 22 mm, Diameter | In distribution |
| 65-7711-015-20 | 12/14 Neck Taper, Size 15 | In distribution |
| 00-7712-020-64 | 0 mm Rasp, Size 20 | In distribution |
| 7210-26-350 | 26 mm, Diameter | In distribution |
| 7712-17-60 | Size 17.5 | In distribution |
| 7210-32-800 | 32 mm, Diameter | In distribution |
| 7210-28-004 | 28 mm, Diameter | In distribution |
| 7205-55-028 | -5.0 mm Neck, 28 mm, Diameter | In distribution |
| 7205-00-028 | 28 mm, Diameter | In distribution |
| 65-7711-007-20 | 12/14 Neck Taper, Size 7.5 | In distribution |
| 00-7712-017-64 | 0 mm Rasp, Size 17.5 | In distribution |
| 65-7711-022-00 | 12/14 Neck Taper, Size 22.5 | In distribution |
| 7210-32-004 | 32 mm, Diameter | In distribution |
| 7712-07-60 | Size 7.5 | In distribution |
| 65-7711-006-20 | 12/14 Neck Taper, Size 6 | In distribution |
| 7205-10-032 | +10.0 mm Neck, 32 mm, Diameter | In distribution |
| 65-7711-013-00 | 12/14 Neck Taper, Size 13.5 | In distribution |
| 00-7711-004-10 | 12/14 Neck Taper, Size 4 | In distribution |
| 7210-26-000 | 26 mm, Diameter | In distribution |
| 00-7712-006-64 | 0 mm Rasp, Size 6 | In distribution |
| 65-7711-012-20 | 12/14 Neck Taper, Size 12.5 | In distribution |
| 7210-22-000 | 22 mm, Diameter | In distribution |
| 7712-22-60 | Size 22.5 | In distribution |
| 65-7711-012-40 | 12/14 Neck Taper, Size 12.5 | In distribution |
| 65-7711-006-10 | 12/14 Neck Taper, Size 6 | In distribution |
| 00-7712-013-64 | 0 mm Rasp, Size 13.5 | In distribution |
| 7210-32-000 | 32 mm, Diameter | In distribution |
| 7205-05-026 | +5.0 mm Neck, 26 mm, Diameter | In distribution |
| 65-7711-005-00 | 12/14 Neck Taper, Size 5 | In distribution |
| 7712-15-60 | Size 15 | In distribution |
| 7205-10-028 | +10.0 mm Neck, 28 mm, Diameter | In distribution |
| 7210-22-800 | 22 mm, Diameter | In distribution |
| 7712-13-60 | Size 13.5 | In distribution |
| 7205-58-032 | -8.0 mm Neck, 32 mm, Diameter | In distribution |
| 7205-55-032 | -5.0 mm Neck, 32 mm, Diameter | In distribution |
| 65-7711-011-10 | 12/14 Neck Taper, Size 11 | In distribution |
| 7210-32-400 | 32 mm, Diameter | In distribution |
| 7210-26-035 | 26 mm, Diameter | In distribution |
| 7205-00-026 | 26 mm, Diameter | In distribution |
| 7210-28-400 | 28 mm, Diameter | In distribution |
| 65-7711-007-10 | 12/14 Neck Taper, Size 7.5 | In distribution |
| 7210-28-800 | 28 mm, Diameter | In distribution |
| 65-7711-017-00 | 12/14 Neck Taper, Size 17.5 | In distribution |
| 65-7711-017-20 | 12/14 Neck Taper, Size 17.5 | In distribution |
| 65-7711-020-00 | 12/14 Neck Taper, Size 20 | In distribution |
| 65-7711-012-10 | 12/14 Neck Taper, Size 12.5 | In distribution |
| 7205-55-026 | -5.0 mm Neck, 26 mm, Diameter | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Alteon | Exactech, Inc. | 326 |
| Novation | Exactech, Inc. | 317 |
| Pinnacle | Depuy Orthopaedics, Inc. | 305 |
| SP-CL Hip Stem | Waldemar Link GmbH & Co. KG | 219 |
| Emperion | Smith & Nephew, Inc. | 201 |
| MobileLink Acetabular Cup System | Waldemar Link GmbH & Co. KG | 154 |
| Instrument | Howmedica Osteonics Corp | 145 |
| Restoration | Howmedica Osteonics Corp | 144 |
| Mfinity Femoral System | Medacta International SA | 138 |
| Echelon | Smith & Nephew, Inc. | 134 |
| Trinity Acetabular Hip System | Corin Limited | 128 |
| Redapt | Smith & Nephew, Inc. | 127 |
Showing 12 of 805. All products under Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K925607 | 1993-11-08 |
| K912263 | 1991-08-29 |
Recalls Naming This Product
7 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 |
|---|---|---|---|---|---|---|---|
| Zimmer, Inc. | 510(k) number | 2018-05-30 | Class II | Packaging | M/L Taper Hip Prosthesis and M/L Taper Hip Prosthesis with Kinectiv Technology manufactured prior to October 2015 are being recalled due to the potential for black residue to be observed within the polyethylene bag containing the implant. T | 280 | 2020-05-28 |
| Zimmer, Inc. | 510(k) number | 2018-03-01 | Class II | Labeling mix-ups | Certain packages labeled as size 7.5 Extended Offset Reduced Neck length hip implant, actually contained a Size 4 Standard Reduced Neck length taper hip implant. | 12 | 2019-07-18 |
| Zimmer, Inc. | 510(k) number | 2018-03-01 | Class II | Labeling mix-ups | Certain packages labeled as size 7.5 Extended Offset Reduced Neck length hip implant, actually contained a Size 4 Standard Reduced Neck length taper hip implant. | 24 | 2019-07-18 |
| Zimmer, Inc. | 510(k) number | 2016-02-11 | Class II | Under Investigation by firm | Zimmer Biomet initiated a lot-specific voluntary recall on 02/11/2016, of the M/L Taper Hip Prosthesis. single manufacturing lot of Size 12.5, Extended Offset, M/L Taper hip stems was incorrectly etched. The device was etched as STD, rathe | 9 units | 2016-12-01 |
| Zimmer, Inc. | 510(k) number | 2014-12-17 | Class II | Package design/selection | Potential compromise of the inner sterile tray. If a compromised tray is detected, a delay in surgery may result. If undetected breach in both the inner and outer trays were to occur, and there is contamination present, a periprosthetic inf | 6109 | 2015-09-23 |
| Zimmer, Inc. | 510(k) number | 2014-05-23 | Class II | Packaging | Black residue observed in the sterile pouch of the M/L Taper and Kinectiv stems. | 1487 units | 2015-03-06 |
| Zimmer, Inc. | 510(k) number | 2012-09-14 | Class II | Process control | Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded the recall action to include lots of Uni | 275,952 units | 2014-06-20 |
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.