G7
51 catalogue numbers from 110017239, listed by Biomet Orthopedics, United States, under Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented. 15 manufacturers in China are registered for this product code.
15manufacturers in China registered for this device type
51catalogue numbers in this listing
1510(k) clearance
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 | Biomet Orthopedics, United States |
|---|---|
| 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 |
| 510(k) | K121874 |
| Record published | 2016-09-23 |
| Record revised | 2025-05-30 (version 9) |
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 |
|---|---|---|
| 110017239 | SIZE 28MM G | In distribution |
| 010002723 | In distribution | |
| SSI005110 | 71mm | In distribution |
| 010002642 | 44 mm H | In distribution |
| 010002507 | 40MM, +9MM NECK LENGTH | In distribution |
| 110002767 | Size G | In distribution |
| 110003454 | In distribution | |
| 010002473 | 72 mm | In distribution |
| 010002690 | 32 mm C 10° | In distribution |
| 010002728 | 44 mm | In distribution |
| 010002751 | In distribution | |
| 010002506 | 40 mm / +12 mm Neck Length | In distribution |
| 010002448 | 47 mm | In distribution |
| 010002657 | 32 mm D | In distribution |
| SSI005114 | 77mm | In distribution |
| 110010300 | SIZE 36MM E | In distribution |
| 010002449 | 48 mm | In distribution |
| 010002624 | 32 mm E | In distribution |
| 010002650 | 28 mm F | In distribution |
| 010002715 | Size C | In distribution |
| 010002707 | 40 mm H 10° | In distribution |
| 010002442 | 41MM | In distribution |
| 010002675 | 40 mm J | In distribution |
| 010002464 | 63MM | In distribution |
| 010002622 | 32 mm C | In distribution |
| SSI005112 | 75mm | In distribution |
| 010002530 | 28MM, +7MM NECK LENGTH | In distribution |
| 010002691 | 32 mm D 10° | In distribution |
| 110017236 | SIZE 28MM D | In distribution |
| 010002722 | Size J | In distribution |
| 110002763 | Size C | In distribution |
| 010002480 | 79 mm | In distribution |
| 110017241 | SIZE 28MM I | In distribution |
| 010002717 | Size E | In distribution |
| 010002637 | 40 mm F | In distribution |
| 010002445 | 44 mm | In distribution |
| 010002444 | 43 mm | In distribution |
| SSI005109 | 69mm | In distribution |
| 010002503 | 36MM, STD NECK LENGTH | In distribution |
| 110003455 | In distribution | |
| 010002506 | 40MM, +12MM NECK LENGTH | In distribution |
| 010002494 | 32 mm / +6 mm Neck Length | In distribution |
| 010002716 | Size D | In distribution |
| 110017236 | 28 mm / Size D +5 mm | In distribution |
| 010002726 | 36 mm | In distribution |
| 010002684 | 28 mm F 10° | In distribution |
| 010002488 | 28MM, +3MM NECK LENGTH | In distribution |
| 010002694 | 32 mm G 10° | In distribution |
| 110017238 | SIZE 28MM F | In distribution |
| 010002514 | 44 mm / +9 mm Neck Length | In distribution |
| 010002750 | 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 |
|---|---|
| K200196 | 2020-12-08 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Zimmer, Inc. | 510(k) number | 2022-08-25 | Class II | Under Investigation by firm | The outer sterile package cavity has a corner wall thickness that is below the specification. The thin corner wall could potentially crack during transit. Potential risks include non-clinically or clinically significant extension of surgery | 56 US | |
| Biomet, Inc. | 510(k) number | 2014-05-07 | Class II | Use error | Guide rod may fracture during impaction of the acetabular shell and be retained in the inserter or the patient and could result in a delay in surgery. | 1047 total | 2015-10-30 |
| Biomet, Inc. | 510(k) number | 2014-05-07 | Class II | Use error | Guide rod may fracture during impaction of the acetabular shell and be retained in the inserter or the patient and could result in a delay in surgery. | 1047 total | 2015-10-30 |
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.