Biomet Cemented CUP HIP System
28 catalogue numbers from XL-223250, listed by Biomet Orthopedics, United States, under Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented. 13 manufacturers in China are registered for this product code.
13manufacturers in China registered for this device type
28catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (3), Zhejiang (2). 9 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 |
| 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 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
Showing 12 of 13. All 13 manufacturers in China registered for Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Record
| Listed by | Biomet Orthopedics, United States |
|---|---|
| FDA product code | JDI |
| Device type | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3350 |
| 510(k) | K042051 |
| Record published | 2015-10-24 |
| Record revised | 2025-05-30 (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 |
|---|---|---|
| XL-223250 | 32MM HEAD SIZE 50MM REAM | In distribution |
| XL-213658 | 36MM HEAD SIZE 58MM REAM | In distribution |
| XL-212846 | 28mm Head Size 46mm Ream | In distribution |
| XL-212844 | 28mm Head Size 44mm Ream | In distribution |
| XL-213666 | 36mm Head Size 66mm Ream | In distribution |
| XL-213660 | 36MM HEAD SIZE 60MM REAM | In distribution |
| XL-223664 | 36MM HEAD SIZE 64MM REAM | In distribution |
| XL-223664 | 36mm Head Size 64mm Ream | In distribution |
| XL-223666 | 36MM HEAD SIZE 66MM REAM | In distribution |
| XL-213664 | 36MM HEAD SIZE 64MM REAM | In distribution |
| XL-223250 | 32mm Head Size 50mm Ream | In distribution |
| XL-222844 | 28MM HEAD SIZE 44MM REAM | In distribution |
| XL-212642 | 26MM HEAD SIZE 42MM REAM | In distribution |
| XL-213654 | 36MM HEAD SIZE 54MM REAM | In distribution |
| XL-213662 | 36MM HEAD SIZE 62MM REAM | In distribution |
| XL-222846 | 28MM HEAD SIZE 46MM REAM | In distribution |
| XL-213658 | 36mm Head Size 58mm Ream | In distribution |
| XL-223662 | 36MM HEAD SIZE 62MM REAM | In distribution |
| XL-213664 | 36mm Head Size 64mm Ream | In distribution |
| XL-223652 | 36MM HEAD SIZE 52MM REAM | In distribution |
| XL-222642 | 26MM HEAD SIZE 42MM REAM | In distribution |
| XL-223656 | 36MM HEAD SIZE 56MM REAM | In distribution |
| XL-213654 | 36mm Head Size 54mm Ream | In distribution |
| XL-213666 | 36MM HEAD SIZE 66MM REAM | In distribution |
| XL-223248 | 32mm Head Size 48mm Ream | In distribution |
| XL-222844 | 28mm Head Size 44mm Ream | In distribution |
| XL-223660 | 36MM HEAD SIZE 60MM REAM | In distribution |
| XL-223652 | 36mm Head Size 52mm Ream | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Zimmer, Inc. | 836 |
| R3 | Smith & Nephew, Inc. | 497 |
| UniSyn Hip System | Shalby Advanced Technologies, Inc. | 247 |
| UniSyn® Hip System | Consensus Orthopedics, Inc. | 247 |
| Reflection | Smith & Nephew, Inc. | 170 |
| Instrument | Howmedica Osteonics Corp | 167 |
| Echelon | Smith & Nephew, Inc. | 159 |
| B-P Total HIP System | Endotec, Inc. | 151 |
| ZCA® | Zimmer, Inc. | 149 |
| Omnifit | Howmedica Osteonics Corp | 149 |
| Ringloc HIP System | Biomet Orthopedics | 139 |
| Profemur | Microport Orthopedics Inc. | 113 |
Showing 12 of 444. All products under Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253515 | 2026-08-24 |
| K023085 | 2002-10-17 |
| K020076 | 2002-01-30 |
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 |
|---|---|---|---|---|---|---|---|
| Biomet, Inc. | 510(k) number | 2017-02-17 | Class II | Process design | Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components. | 28,253 in total | 2018-01-29 |
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.