Biomet HIP System
12 catalogue numbers from 163133, listed by Biomet Orthopedics, United States, under Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented. 15 manufacturers in China are registered for this product code.
15manufacturers in China registered for this device type
12catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (8), Shanghai (3), Zhejiang (2). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| 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 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
Showing 12 of 15. All 15 manufacturers in China registered for Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Record
| Listed by | Biomet Orthopedics, United States |
|---|---|
| FDA product code | LZO |
| Device type | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3353 |
| 510(k) | K915641 |
| Record published | 2015-10-24 |
| Record revised | 2025-05-30 (version 6) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 163133 | 28MM Ø TYPE 1 TAPER | In distribution |
| 163132 | 28MM Ø TYPE 1 TAPER | In distribution |
| 163672 | 32mm Ø Type1 Taper | In distribution |
| 163136 | 32MM Ø TYPE 1 TAPER | In distribution |
| 163138 | 32MM Ø TYPE 1 TAPER | In distribution |
| 163131 | 28MM Ø TYPE 1 TAPER | In distribution |
| 163130 | 28MM Ø TYPE 1 TAPER | In distribution |
| 163134 | 28MM Ø TYPE 1 TAPER | In distribution |
| 163135 | 32MM Ø TYPE 1 TAPER | In distribution |
| 163137 | 32MM Ø TYPE 1 TAPER | In distribution |
| 163139 | 32MM Ø TYPE 1 TAPER | In distribution |
| 163665 | 28mm Ø Type1 Taper | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Libertas | Maxx Orthopedics Inc. | 1,832 |
| Redapt | Smith & Nephew, Inc. | 326 |
| Bencox Hip System | Corentec Co., Ltd. | 295 |
| M-Vizion Femoral Revision System | Medacta International SA | 289 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Zimmer, Inc. | 280 |
| Profemur® | Microport Orthopedics Inc. | 229 |
| DJO Surgical | Encore Medical, L.P. | 162 |
| Instrument | Howmedica Osteonics Corp | 152 |
| Alteon | Exactech, Inc. | 151 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Exactech, Inc. | 136 |
| Resolve Modular Revision Hip Stem | United Orthopedic Corp. | 136 |
| Wagner SL Revision® | Zimmer, Inc. | 133 |
Showing 12 of 691. All products under Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K200196 | 2020-12-08 |
Recalls Naming This Product
14 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 |
|---|---|---|---|---|---|---|---|
| Biomet, Inc. | 510(k) number | 2020-11-25 | Class II | Process control | Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device. | 7428 | 2024-05-08 |
| Biomet, Inc. | 510(k) number | 2018-04-02 | Class II | Nonconforming Material/Component | Two lots of different sized modular heads potentially commingled. Risks include delay in surgery and dislocation due to use of an incorrect sized head. | 30 | 2020-05-12 |
| Biomet, Inc. | 510(k) number | 2015-11-17 | Class II | Labeling Change Control | PMMA is listed as a material on the label but the product does not contain PMMA. | 21 | 2016-07-05 |
| Biomet, Inc. | 510(k) number | 2015-04-16 | Class III | Labeling mix-ups | Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes. | 1315 | 2016-05-16 |
| Biomet, Inc. | 510(k) number | 2003-06-18 | Not classified | Other | The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place. | 16 | 2003-09-23 |
| Biomet, Inc. | 510(k) number | 2003-06-18 | Not classified | Other | The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place. | 5 | 2003-09-23 |
| Biomet, Inc. | 510(k) number | 2003-06-18 | Not classified | Other | The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place. | 12 | 2003-09-23 |
| Biomet, Inc. | 510(k) number | 2003-06-18 | Not classified | Other | The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place. | 33 | 2003-09-23 |
| Biomet, Inc. | 510(k) number | 2003-06-18 | Not classified | Other | The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place. | 30 | 2003-09-23 |
| Biomet, Inc. | 510(k) number | 2003-06-18 | Not classified | Other | The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place. | 28 | 2003-09-23 |
| Biomet, Inc. | 510(k) number | 2003-06-18 | Not classified | Other | The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place. | 16 | 2003-09-23 |
| Biomet, Inc. | 510(k) number | 2003-06-18 | Not classified | Other | The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place. | 25 | 2003-09-23 |
| Biomet, Inc. | 510(k) number | 2003-06-18 | Not classified | Other | The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place. | 35 | 2003-09-23 |
| Biomet, Inc. | 510(k) number | 2003-06-18 | Not classified | Other | The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place. | 31 | 2003-09-23 |
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.