Mectacer Biolox Delta Femoral Ball Head
MectaCer BIOLOX delta femoral heads are ceramic ball components for total or partial hip replacement in skeletally mature patients. They replace the femoral ball in primary or revision…
MectaCer BIOLOX delta femoral heads are ceramic ball components for total or partial hip replacement in skeletally mature patients. They replace the femoral ball in primary or revision surgery and are mechanically fixed to a compatible hip stem.
The head is made from an alumina matrix ceramic composite containing zirconia and trace elements. It connects to a matching 12/14 stem taper. The range includes head diameters up to 44 mm and neck lengths from Small to Extra Large, allowing different reconstructions with the corresponding stem.
Listed Item
Femoral Head Ø 44 Size XL
Clinical Use
Indications include painful or disabled arthritic hips, avascular necrosis, congenital hip dysplasia and acute femoral head or neck fracture. Revision after failed hip surgery requires sufficient remaining bone stock.
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 | Medacta International SA, Switzerland |
|---|---|
| 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, Private-label distributor, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K112115 |
| Record published | 2014-11-18 |
| Record revised | 2020-09-09 (version 4) |
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 |
|---|---|---|
| 01.29.205 | In distribution | |
| 01.29.210 | In distribution | |
| 01.29.216 | In distribution | |
| 01.29.219 | In distribution | |
| 01.29.214 | In distribution | |
| 01.29.204 | In distribution | |
| 01.29.211 | In distribution | |
| 01.29.212 | In distribution | |
| 01.29.217 | In distribution | |
| 01.29.207 | In distribution | |
| 01.29.203 | In distribution | |
| 01.29.218 | In distribution | |
| 01.29.215 | In distribution | |
| 01.29.208 | In distribution | |
| 01.29.213 | In distribution | |
| 01.29.209 | In distribution | |
| 01.29.201 | In distribution | |
| 01.29.206 | In distribution | |
| 01.29.202 | 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 |
|---|---|
| K160289 | 2016-05-20 |
| K151531 | 2015-10-30 |
| K131518 | 2013-11-04 |
| K131458 | 2013-10-01 |
| K122911 | 2012-10-19 |
| K122641 | 2012-09-28 |
| K121011 | 2012-06-08 |
| K120531 | 2012-04-18 |
| K112115 | 2011-10-07 |
| K103352 | 2011-02-11 |
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.