Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
cup insert 10° offset 5 mm implacross® E
5manufacturers in China registered for this device type
40catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (2), Zhejiang (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
Record
| Listed by | implantcast GmbH, Germany |
|---|---|
| FDA product code | OQI |
| Device type | Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3353 |
| Establishment | Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2026-05-06 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 25864005 | Ø 40 mm / sz. M | In distribution |
| 02584058 | Ø 40 mm / sz. E | In distribution |
| 25862800 | Ø 28 mm / sz. S | In distribution |
| 02563658 | Ø 36 mm / sz. E | In distribution |
| 02583650 | Ø 36 mm / sz. C | In distribution |
| 02584062 | Ø 40 mm / sz. F | In distribution |
| 02554058 | Ø 40 mm / sz. E | In distribution |
| 02584066 | Ø 40 mm / sz. G | In distribution |
| 02553650 | Ø 36 mm / sz. C | In distribution |
| 25864000 | Ø 40 mm / sz. S | In distribution |
| 25864010 | Ø 40 mm / sz. L | In distribution |
| 02562842 | Ø 28 mm / sz. A | In distribution |
| 02564054 | Ø 40 mm / sz. D | In distribution |
| 02554066 | Ø 40 mm / sz. G | In distribution |
| 25862805 | Ø 28 mm / sz. M | In distribution |
| 02583246 | Ø 32 mm / sz. B | In distribution |
| 02552842 | Ø 28 mm / sz. A | In distribution |
| 02564058 | Ø 40 mm / sz. E | In distribution |
| 02563246 | Ø 32 mm / sz. B | In distribution |
| 02564062 | Ø 40 mm / sz. F | In distribution |
| 25864015 | Ø 40 mm / sz. XL | In distribution |
| 02583662 | Ø 36 mm / sz. F | In distribution |
| 02554062 | Ø 40 mm / sz. F | In distribution |
| 02583666 | Ø 36 mm / sz. G | In distribution |
| 02563666 | Ø 36 mm / sz. G | In distribution |
| 02563662 | Ø 36 mm / sz. F | In distribution |
| 02554054 | Ø 40 mm / sz. D | In distribution |
| 25862810 | Ø 28 mm / sz. L | In distribution |
| 02563654 | Ø 36 mm / sz. D | In distribution |
| 02583654 | Ø 36 mm / sz. D | In distribution |
| 02553654 | Ø 36 mm / sz. D | In distribution |
| 02553246 | Ø 32 mm / sz. B | In distribution |
| 02563650 | Ø 36 mm / sz. C | In distribution |
| 02553662 | Ø 36 mm / sz. F | In distribution |
| 02564066 | Ø 40 mm / sz. G | In distribution |
| 02582842 | Ø 28 mm / sz. A | In distribution |
| 02553658 | Ø 36 mm / sz. E | In distribution |
| 02583658 | Ø 36 mm / sz. E | In distribution |
| 02584054 | Ø 40 mm / sz. D | In distribution |
| 02553666 | Ø 36 mm / sz. G | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Kyocera Medical Technologies, Inc. | Kyocera Medical Technologies, Inc. | 260 |
| Epore® XO | implantcast GmbH | 64 |
| G7® | Biomet Orthopedics | 50 |
| InSitu Hip System | Nextstep Arthropedix | 50 |
| G7 Acetabular Liner | Biomet Orthopedics | 47 |
| Novation | Exactech, Inc. | 37 |
| Trinity Acetabular Hip System with ECiMa Liners | Corin Limited | 28 |
| Procotyl® Prime | Microport Orthopedics Inc. | 25 |
| AcuMatch | Exactech, Inc. | 23 |
| Continuum® Trilogy® Allofit® | Zimmer, Inc. | 23 |
| G7® Longevity® | Zimmer, Inc. | 23 |
| Continuum® Trilogy® Allofit® Vivacit-E® | Zimmer, Inc. | 22 |
Showing 12 of 164. All products under Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K252451 | 2026-04-24 |
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.