Full XPE Cup
Full XPE Cup is a cemented acetabular implant made from highly cross-linked ultra-high-molecular-weight polyethylene. It is assembled with a polymethyl methacrylate spacer and a metal X-ray…
Full XPE Cup is a cemented acetabular implant made from highly cross-linked ultra-high-molecular-weight polyethylene. It is assembled with a polymethyl methacrylate spacer and a metal X-ray marking wire. The marking wire allows identification on radiographs, and the range includes sizes for different anatomical requirements.
The cup is compatible with corresponding UNITED metal or ceramic femoral heads. It can also be cemented into a corresponding UNITED Locking Cage. These are separate components: the cup provides the polyethylene acetabular bearing, while the cage addresses deficient acetabular bone.
Listed Item
Full XPE cup, ID 32mm, OD 48mm
Hip Replacement Applications
Cup indications include inflammatory or noninflammatory degenerative joint disease, functional deformity correction and revision following failed treatment. Specified proximal femoral fractures involving the head are also included when other techniques cannot manage them. The Full XPE Cup is a single-use implant for cemented use only.
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) | K163441 |
| Record published | 2017-10-06 |
| Record revised | 2018-08-08 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1302-3248 | ID 32mm | In distribution |
| 1302-3660 | ID 36mm | In distribution |
| 1302-3254 | ID 32mm | In distribution |
| 1302-3252 | ID 32mm | In distribution |
| 1302-3656 | ID 36mm | In distribution |
| 1302-3844 | ID 28mm | In distribution |
| 1302-3260 | ID 32mm | In distribution |
| 1302-3262 | ID 32mm | In distribution |
| 1302-3256 | ID 32mm | In distribution |
| 1302-3658 | ID 36mm | In distribution |
| 1302-3654 | ID 36mm | In distribution |
| 1302-3846 | ID 28mm | In distribution |
| 1302-3662 | ID 36mm | In distribution |
| 1302-3250 | ID 32mm | In distribution |
| 9203-8510 | In distribution | |
| 1302-3258 | ID 32mm | In distribution |
| 1302-3042 | ID 26mm | In distribution |
| 1302-3652 | ID 36mm | 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.