Corin Metafix Hip Stem
Double Offset Handle (greatbatch)
15manufacturers in China registered for this device type
30catalogue numbers in this listing
2510(k) clearances naming this product code
2recalls on this code
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 | Corin Limited, United Kingdom |
|---|---|
| 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 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K082525 |
| Record published | 2016-08-17 |
| Record revised | 2019-02-07 (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 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 340.436R | In distribution | |
| 340.434R | In distribution | |
| 340.453 | In distribution | |
| 579.0010 | In distribution | |
| 579.2003 | In distribution | |
| 340.472 | In distribution | |
| 340.545 | In distribution | |
| 340.437R | In distribution | |
| 6959670 | In distribution | |
| 340.362 | In distribution | |
| 579.1009 | In distribution | |
| 579.2009 | In distribution | |
| 340.544 | In distribution | |
| 340.311 | In distribution | |
| 340.470 | In distribution | |
| 340.439R | In distribution | |
| 340.300 | In distribution | |
| 579.0008 | In distribution | |
| 340.365 | In distribution | |
| 579.1004 | In distribution | |
| 579.0003 | In distribution | |
| 340.435R | In distribution | |
| 579.1008 | In distribution | |
| 579.0007 | In distribution | |
| 579.0004 | In distribution | |
| 579.0006 | In distribution | |
| 579.1005 | In distribution | |
| 340.440R | In distribution | |
| 579.2007 | In distribution | |
| 340.366 | 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 |
|---|---|
| K201657 | 2021-07-28 |
| K130128 | 2013-03-08 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Corin Limited | 510(k) number | 2022-07-22 | Class II | Process control | One MetaFix size 7 collarless stem from batch 478179 which was incorrectly labelled as a MetaFix size 3 collared stem from batch 485630. | 5 devices |
Recalls
2 of these are 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 |
|---|---|---|---|---|
| 2022-11-08 | Class II | Under Investigation by firm | The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa. | 5 units |
| 2022-11-08 | Class II | Under Investigation by firm | The BIOLOX Delta Ceramic Head size 36XL is labelled as the size 32XL and vice-versa. | 12 units |
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.