UCP Stem, Cemented
The UCP cemented stem is a femoral implant for primary or revision hip replacement. It can be combined with UNITED acetabular components and a femoral head for total hip arthroplasty, or…
The UCP cemented stem is a femoral implant for primary or revision hip replacement. It can be combined with UNITED acetabular components and a femoral head for total hip arthroplasty, or with a UNITED bipolar prosthesis for bipolar replacement. It is intended exclusively for fixation with PMMA bone cement.
The stem has a polished, collarless, triple-tapered design. It is used with a centralizer and cement restrictor. The stem is made from cobalt-chromium-molybdenum alloy, while the centralizer is PMMA and the cement restrictor is ultra-high-molecular-weight polyethylene.
Listed Item
UCP Stem, cemented, #3
Clinical Scope
Indications include degenerative or inflammatory joint disease, specified proximal femoral fractures, failed prior treatments or devices, and disability following previous fusion. The implant is intended for single use.
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) | K152530 |
| Record published | 2016-03-31 |
| Record revised | 2018-08-08 (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 |
|---|---|---|
| 1107-3030 | #3 | In distribution |
| 1107-3020 | #2 | In distribution |
| 1107-3040 | #4 | In distribution |
| 1107-3050 | #5 | In distribution |
| 1107-3010 | #1 | In distribution |
| 1107-3000 | #0 | 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.