U-Motion II PS+ Cup, Cluster-Hole
The U-Motion II PS+ cluster-hole cup is an acetabular component for cementless hip replacement. It is one of three cup series in the family, alongside no-hole and multi-hole configurations.…
The U-Motion II PS+ cluster-hole cup is an acetabular component for cementless hip replacement. It is one of three cup series in the family, alongside no-hole and multi-hole configurations.
The cup is intended for skeletally mature patients with painful disabling hip joint disease and certain revision or reconstructive situations. Conditions include degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis, and late-stage avascular necrosis.
Listed Item
U-Motion II PS+ Cup, cluster-hole, Ø78mm
Cup Material and Surface
The cup is manufactured from titanium alloy forging and has an outer titanium powder coating. Its coating is thicker than that of the earlier U-Motion II PS cup.
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 | United Orthopedic Corp., Taiwan |
|---|---|
| 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, Manufacturer, Exporter |
| 510(k) | K132455 |
| Record published | 2015-10-24 |
| Record revised | 2018-08-07 (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 |
|---|---|---|
| 1306-3178 | Ø78mm | In distribution |
| 1306-3170 | Ø70mm | In distribution |
| 1306-3144 | Ø44mm | In distribution |
| 1306-3160 | Ø60mm | In distribution |
| 1306-3156 | Ø56mm | In distribution |
| 1306-3166 | Ø66mm | In distribution |
| 1306-3154 | Ø54mm | In distribution |
| 1306-3176 | Ø76mm | In distribution |
| 1306-3180 | Ø80mm | In distribution |
| 1306-3174 | Ø74mm | In distribution |
| 1306-3162 | Ø62mm | In distribution |
| 1306-3164 | Ø64mm | In distribution |
| 1306-3150 | Ø50mm | In distribution |
| 1306-3168 | Ø68mm | In distribution |
| 1306-3172 | Ø72mm | In distribution |
| 1306-3148 | Ø48mm | In distribution |
| 1306-3146 | Ø46mm | In distribution |
| 1306-3152 | Ø52mm | In distribution |
| 1306-3158 | Ø58mm | 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 |
|---|---|
| K253948 | 2026-09-02 |
| K243466 | 2025-01-06 |
| K242249 | 2024-08-30 |
| K221149 | 2023-01-05 |
| K183312 | 2019-08-08 |
| K170089 | 2017-10-06 |
| K163441 | 2017-08-25 |
| K152530 | 2016-03-14 |
| K132455 | 2013-09-03 |
| K122185 | 2013-02-22 |
| K112463 | 2011-09-23 |
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.