U2 Acetabular Components, Ti Porous Coated
U2 Acetabular cup, Ti porous coated, Ø80mm
14manufacturers in China registered for this device type
19catalogue numbers in this listing
15510(k) clearances naming this product 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 | United Orthopedic Corp., Taiwan |
|---|---|
| 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, Manufacturer, Exporter |
| 510(k) | K111546 |
| Record published | 2015-10-24 |
| Record revised | 2018-08-03 (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 |
| Sizes | Outer diameter 44 to 80 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1303-5480 | Outer Diameter 80 mm | In distribution |
| 1303-5456 | Outer Diameter 56 mm | In distribution |
| 1303-5460 | Outer Diameter 60 mm | In distribution |
| 1303-5472 | Outer Diameter 72 mm | In distribution |
| 1303-5458 | Outer Diameter 58 mm | In distribution |
| 1303-5450 | Outer Diameter 50 mm | In distribution |
| 1303-5444 | Outer Diameter 44 mm | In distribution |
| 1303-5478 | Outer Diameter 78 mm | In distribution |
| 1303-5468 | Outer Diameter 68 mm | In distribution |
| 1303-5446 | Outer Diameter 46 mm | In distribution |
| 1303-5464 | Outer Diameter 64 mm | In distribution |
| 1303-5474 | Outer Diameter 74 mm | In distribution |
| 1303-5470 | Outer Diameter 70 mm | In distribution |
| 1303-5476 | Outer Diameter 76 mm | In distribution |
| 1303-5448 | Outer Diameter 48 mm | In distribution |
| 1303-5454 | Outer Diameter 54 mm | In distribution |
| 1303-5462 | Outer Diameter 62 mm | In distribution |
| 1303-5452 | Outer Diameter 52 mm | In distribution |
| 1303-5466 | Outer Diameter 66 mm | 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 |
|---|---|
| K221675 | 2022-11-04 |
| K172251 | 2017-10-24 |
| K162957 | 2017-07-17 |
| K163193 | 2017-06-08 |
| K151316 | 2015-08-13 |
| K132207 | 2013-08-30 |
| K130149 | 2013-06-06 |
| K123550 | 2013-05-01 |
| K122504 | 2012-10-10 |
| K121777 | 2012-07-18 |
| K110245 | 2011-08-04 |
| K111546 | 2011-07-01 |
| K022520 | 2003-02-25 |
| K003237 | 2001-01-10 |
| K994078 | 2000-12-04 |
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 | Closed |
|---|---|---|---|---|---|---|---|
| Orthopedic Alliance, LLC | 510(k) number | 2013-02-20 | Class II | Labeling design | The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery. | 21 units | 2014-03-26 |
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.