Emphasys
Emphasys Polyethylene Liner Elevated RIM AOX 38MM 22.225MM
15manufacturers in China registered for this device type
29catalogue numbers in this listing
17510(k) clearances naming this product code
1recall
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 | Depuy Orthopaedics, Inc., 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 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Record published | 2022-10-05 |
| Record revised | 2024-09-26 (version 2) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4722-52-432 | In distribution | |
| 4722-64-240 | In distribution | |
| 4722-64-036 | In distribution | |
| 4722-56-240 | In distribution | |
| 4722-56-432 | In distribution | |
| 4722-56-436 | In distribution | |
| 4722-38-222 | In distribution | |
| 4722-54-240 | In distribution | |
| 4722-54-036 | In distribution | |
| 4722-64-040 | In distribution | |
| 4722-60-036 | In distribution | |
| 4722-50-436 | In distribution | |
| 4722-52-040 | In distribution | |
| 4722-38-022 | In distribution | |
| 4722-52-036 | In distribution | |
| 4722-54-440 | In distribution | |
| 4722-60-240 | In distribution | |
| 4722-60-236 | In distribution | |
| 4722-52-236 | In distribution | |
| 4722-48-236 | In distribution | |
| 4722-50-432 | In distribution | |
| 4722-60-040 | In distribution | |
| 4722-54-436 | In distribution | |
| 4722-52-436 | In distribution | |
| 4722-60-436 | In distribution | |
| 4722-56-036 | In distribution | |
| 4722-42-028 | In distribution | |
| 4722-52-240 | In distribution | |
| 4722-42-228 | 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 |
|---|---|
| K213839 | 2022-01-06 |
| K203167 | 2020-11-19 |
| K192946 | 2019-11-26 |
| K170339 | 2018-04-26 |
| K123924 | 2013-03-01 |
| K093736 | 2011-03-10 |
| K073570 | 2008-02-21 |
| K071830 | 2007-09-28 |
| K070554 | 2007-09-11 |
| K062748 | 2006-11-30 |
| K042992 | 2005-02-11 |
| K040644 | 2004-04-08 |
| K031803 | 2003-07-01 |
| K011533 | 2002-01-28 |
| K002441 | 2000-09-01 |
| K000432 | 2000-04-24 |
| K000392 | 2000-04-24 |
Recalls
1 of these is 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 | Closed |
|---|---|---|---|---|---|
| 2014-11-07 | Class II | Mixed-up of materials/components | Two complaints reported that the BIOLOX delta TS Ceramic Femoral Articul/eze12/14 36mm +12 Head (product code 1365-36-740) did not fit like the trial; the definite hip construct felt loose. The loosening refers to tissue tension and not the | 19 units worldwide | 2015-03-24 |
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.