Emphasys
Emphasys Polyethylene Liner Elevated RIM AOX 40MM 22.225MM
14manufacturers in China registered for this device type
23catalogue numbers in this listing
33510(k) clearances naming this product code
23recalls on this code
Who Else Makes It
Concentrated in Jiangsu (7), 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 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| Guangzhou Aquila Precise Tools Limited | Guangzhou | Guangdong | Contract manufacturer | 28 |
| 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 |
| 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 14. All 14 manufacturers in China registered for Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Record
| Listed by | Depuy Orthopaedics, Inc., United States |
|---|---|
| FDA product code | LPH |
| Device type | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3358 |
| 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 |
|---|---|---|
| 4722-64-432 | In distribution | |
| 4722-48-432 | In distribution | |
| 4722-64-440 | In distribution | |
| 4722-54-236 | In distribution | |
| 4722-60-440 | In distribution | |
| 4722-64-436 | In distribution | |
| 4722-40-022 | In distribution | |
| 4722-48-036 | In distribution | |
| 4722-50-036 | In distribution | |
| 4722-50-236 | In distribution | |
| 4722-56-040 | In distribution | |
| 4722-40-028 | In distribution | |
| 4722-60-432 | In distribution | |
| 4722-48-436 | In distribution | |
| 4722-46-432 | In distribution | |
| 4722-64-236 | In distribution | |
| 4722-56-236 | In distribution | |
| 4722-40-222 | In distribution | |
| 4722-54-040 | In distribution | |
| 4722-56-440 | In distribution | |
| 4722-52-440 | In distribution | |
| 4722-40-228 | In distribution | |
| 4722-54-432 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Initia Total Hip System | Kyocera Medical Technologies, Inc. | 1,000 |
| DJO Surgical | Encore Medical, L.P. | 624 |
| Pinnacle | Depuy Orthopaedics, Inc. | 613 |
| Trilogy® Longevity® | Zimmer, Inc. | 564 |
| Instrument | Howmedica Osteonics Corp | 369 |
| InSitu Hip System | Nextstep Arthropedix | 368 |
| Trilogy® | Zimmer, Inc. | 359 |
| Kyocera Medical Technologies, Inc. | Kyocera Medical Technologies, Inc. | 298 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Zimmer, Inc. | 286 |
| Bencox Hip System | Corentec Co., Ltd. | 286 |
| OrthoMedFlex | Orthomedflex LLC | 257 |
| Sterizo Total Hip System | CPM Medical Consultants, LLC. | 240 |
Showing 12 of 792. All products under Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K202472 | 2020-10-21 |
| K192919 | 2019-11-26 |
| K132959 | 2014-03-10 |
| K120599 | 2013-04-30 |
| K102423 | 2010-10-29 |
| K072963 | 2008-01-09 |
| K071784 | 2007-07-25 |
| K062148 | 2006-10-24 |
| K061833 | 2006-07-17 |
| K060581 | 2006-05-19 |
| K060031 | 2006-01-31 |
| K040383 | 2004-05-12 |
| K033273 | 2004-05-06 |
| K033893 | 2004-03-12 |
| K033338 | 2004-01-08 |
| K031495 | 2003-06-11 |
| K030979 | 2003-04-24 |
| K012364 | 2001-10-19 |
| K011489 | 2001-07-31 |
| K010171 | 2001-04-06 |
| K010367 | 2001-03-09 |
| K003875 | 2001-03-01 |
| K003800 | 2001-02-09 |
| K001991 | 2000-08-25 |
| K001982 | 2000-07-26 |
| K001778 | 2000-07-07 |
| K001277 | 2000-06-23 |
| K001534 | 2000-06-12 |
| K000306 | 2000-03-23 |
| K000207 | 2000-02-04 |
| K994415 | 2000-02-03 |
| K984459 | 1999-01-28 |
| K983491 | 1998-12-02 |
Recalls
23 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 | Closed |
|---|---|---|---|---|---|
| 2012-12-03 | Class II | Device Design | An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement v | 1732 total product codes | 2013-11-13 |
| 2012-12-03 | Class II | Device Design | An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement v | 1732 total all product codes | 2013-11-13 |
| 2012-12-03 | Class II | Device Design | An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement v | 1732 total all product codes | 2013-11-13 |
| 2012-12-03 | Class II | Device Design | An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement v | 1732 total all product codes | 2013-11-13 |
| 2012-12-03 | Class II | Device Design | An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement v | 1732 total all product codes | 2013-11-13 |
| 2012-12-03 | Class II | Device Design | An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement v | 1732 total all product codes | 2013-11-13 |
| 2012-12-03 | Class II | Device Design | An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement v | 1732 total all product codes | 2013-11-13 |
| 2012-12-03 | Class II | Device Design | An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement v | 1732 total all product codes | 2013-11-13 |
| 2012-12-03 | Class II | Device Design | An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement v | 1732 total all product codes | 2013-11-13 |
| 2012-12-03 | Class II | Device Design | An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement v | 1732 total all product codes | 2013-11-13 |
| 2012-12-03 | Class II | Device Design | An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement v | 1732 total all product codes | 2013-11-13 |
| 2012-12-03 | Class II | Device Design | An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement v | 1732 total all product codes | 2013-11-13 |
| 2012-12-03 | Class II | Device Design | An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement v | 1732 total all product codes | 2013-11-13 |
| 2012-12-03 | Class II | Device Design | An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement v | 1732 total all product codes | 2013-11-13 |
| 2012-12-03 | Class II | Device Design | An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement v | 1732 total all product codes | 2013-11-13 |
| 2012-12-03 | Class II | Device Design | An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement v | 1732 total all product codes | 2013-11-13 |
| 2012-12-03 | Class II | Device Design | An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement v | 1732 total all product codes | 2013-11-13 |
| 2012-12-03 | Class II | Device Design | An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement v | 1732 total all product codes | 2013-11-13 |
| 2012-12-03 | Class II | Device Design | An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement v | 1732 total all product codes | 2013-11-13 |
| 2012-12-03 | Class II | Device Design | An Engineering Analysis has determined the Solution Calcar Stem has the potential to result in impingement with a variety of heads. This impingement may not allow the stem and head to lock as intended. The amount of possible impingement v | 1732 total all product codes | 2013-11-13 |
| 2012-11-28 | Class II | Labeling Change Control | DePuy Orthopaedics, Inc. is issuing a voluntary recall of ten lots of the Pinnacle Cancellous Screw due to an incorrect description on the label. The label description reads Pinnacle Cannulated Screw and should read Pinnacle Cancellous Scr | 118 units | 2013-03-20 |
| 2012-07-24 | Class II | Employee error | In the recalled lot, the products were not machined according to the production router, a size 52 cup (122136052) was machined instead. This resulted in a size 52 liner being etched and labeled as a size 54 liner. | 20 liners | 2013-04-30 |
| 2012-03-07 | Class II | Packaging process control | DePuy Orthopaedics, Inc. (DePuy) is issuing a voluntary recall of one lot of the AltrX” liner because the product was incorrectly labeled on the box. The box was labeled for a 36IDX52OD +4 Neutral Liner, but the product enclosed was a 36I | 20 liners | 2013-05-24 |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P880025 | 1991-12-04 | AML(R) POROCOAT(R) ACETABULAR CUP PROSTHESIS | Depuy Intl., Ltd. |
| P880076 | 1991-06-17 | WHITESIDE EPS(TM) FEMORAL HIP PROSTHESIS | Dow Corning Wright |
| P850061 | 1991-03-08 | BIAS(R) FIBER METAL TOTAL HIP SYSTEM | Zimmer, Inc. |
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.