M2a Magnum™ Hip System
21 catalogue numbers from US157862, 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
21catalogue 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) | K042037 |
| Record published | 2017-10-06 |
| Record revised | 2025-05-30 (version 6) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2015-10-24 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| US157862 | 62MM OUTER Ø 56MM INNER Ø | In distribution |
| CP156431 | 40MM Ø TYPE I TAPER | In distribution |
| US157852 | 52MM OUTER Ø 46MM INNER Ø | In distribution |
| CP156435 | 40MM Ø TYPE I TAPER | In distribution |
| US157864 | 64MM OUTER Ø 58MM INNER Ø | In distribution |
| US257866 | 66MM OUTER Ø 60MM INNER Ø | In distribution |
| US257856 | 56MM OUTER Ø 50MM INNER Ø | In distribution |
| US257858 | 58MM OUTER Ø 52MM INNER Ø | In distribution |
| CP156434 | 40MM Ø TYPE I TAPER | In distribution |
| US157856 | 56MM OUTER Ø 50MM INNER Ø | In distribution |
| CP156433 | 40MM Ø TYPE I TAPER | In distribution |
| US257846 | 46MM OUTER Ø 40MM INNER Ø | In distribution |
| CP156432 | 40MM Ø TYPE I TAPER | In distribution |
| CP156436 | 40MM Ø TYPE I TAPER | In distribution |
| US157858 | 58MM OUTER Ø 52MM INNER Ø | In distribution |
| US257862 | 62MM OUTER Ø 56MM INNER Ø | In distribution |
| US257854 | 54MM OUTER Ø 48MM INNER Ø | In distribution |
| 139270 | 52-60MM HEAD SIZE Ø TYPE I TAPER | Withdrawn |
| 139252 | 42-50MM HEAD SIZE Ø TYPE I TAPER | Withdrawn |
| 139264 | 52-60MM HEAD SIZE Ø TYPE I TAPER | Withdrawn |
| 139261 | 42-50MM HEAD SIZE Ø TYPE I TAPER | Withdrawn |
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
3 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 | 2013-04-26 | Class II | Labeling mix-ups | Biomet is recalling Active Articulation E1 Hip Bearing implants. Biomet has initiated this action following an investigation which identified that outer label indicates two conflicting O.D. sizes while the inner labels indicate an incorrec | 8 units | 2013-08-29 |
| Biomet, Inc. | 510(k) number | 2012-02-07 | Not classified | Employee error | Biomet initiated this action after complaints were received where OOS AVL Bushing Sets were opened during OSS knee replacement procedures, and were found to contain two tabbed bushings. | 27 units distributed US and foreign | 2013-02-06 |
| Biomet, Inc. | 510(k) number | 2011-09-13 | Not classified | Nonconforming Material/Component | Devices with a specification for a +6mm neck length were incorrectly labeled for a +3mm neck length specification. | 5 devices | 2013-02-21 |
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.