G7
54 catalogue numbers from 110017402, listed by Biomet Orthopedics, United States, under Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented. 8 manufacturers in China are registered for this product code.
8manufacturers in China registered for this device type
54catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (3), Jiangsu (3), Zhejiang (1). 4 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 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Lincotek (Wuxi) Co., Ltd. | Wuxi | Jiangsu | 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 |
| Shenzhen Fox Hunting E-commerce Co., Ltd. | Shenzhen | Guangdong | Exporter | 7 |
Record
| Listed by | Biomet Orthopedics, United States |
|---|---|
| FDA product code | OQG |
| Device type | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3358 |
| 510(k) | K142882 |
| Record published | 2016-09-23 |
| Record revised | 2025-05-30 (version 10) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 110017402 | SIZE 36MM | In distribution |
| 110003451 | In distribution | |
| SSI005099 | 49mm | In distribution |
| 110004133 | 32/36/40/44MM | In distribution |
| 110017265 | SIZE 44MM I | In distribution |
| 110010308 | SIZE 36MM D | In distribution |
| 010002681 | 28 mm C 10° | In distribution |
| 010002517 | 44MM, STD NECK LENGTH | In distribution |
| 010002660 | 32 mm G | In distribution |
| 010002518 | 44MM, -3.MM NECK LENGTH | In distribution |
| 110017265 | 44 mm Size I / +5 mm | In distribution |
| 110017244 | 32 mm Size C / +5 mm | In distribution |
| 110017260 | 40 mm Size G / +5 mm | In distribution |
| 010002713 | Size A | In distribution |
| SSI005108 | 67mm | In distribution |
| 110010302 | SIZE 36MM G | In distribution |
| 010002468 | 67MM | In distribution |
| 110017252 | SIZE 36MM D | In distribution |
| 010002512 | 40MM, -6MM NECK LENGTH | In distribution |
| 010002514 | 44MM, +9MM NECK LENGTH | In distribution |
| 110017260 | SIZE 40MM G | In distribution |
| 010002508 | 40 mm / +6 mm Neck Length | In distribution |
| 010002499 | 36 mm / +12 mm Neck Length | In distribution |
| 110017245 | SIZE 32MM D | In distribution |
| SSI005105 | 61mm | In distribution |
| 010002467 | 66 mm | In distribution |
| 010002456 | 55MM | In distribution |
| SSI005097 | 43mm | In distribution |
| 010002486 | 28MM, +9MM NECK LENGTH | In distribution |
| 010002724 | 28 mm | In distribution |
| 110017249 | SIZE 32MM H | In distribution |
| 010002487 | 28 mm / +6 mm Neck Length | In distribution |
| 110017258 | 36 mm Size J / +5 mm | In distribution |
| 010002641 | 40 mm J | In distribution |
| 010002460 | 59 mm | In distribution |
| SSI005103 | 57mm | In distribution |
| 010002455 | 54 mm | In distribution |
| 110017235 | SIZE 28MM C | In distribution |
| 010002512 | 40 mm / -6 mm Neck Length | In distribution |
| 110017263 | SIZE 40MM J | In distribution |
| 010002745 | In distribution | |
| 110010313 | SIZE 36MM I | In distribution |
| 110010303 | SIZE 36MM H | In distribution |
| 010002507 | 40 mm / +9 mm Neck Length | In distribution |
| 010002695 | 32 mm H 10° | In distribution |
| 010002472 | 71MM | In distribution |
| 010002497 | 32MM, -3MM NECK LENGTH | In distribution |
| SSI005101 | 53mm | In distribution |
| 010002458 | 57MM | In distribution |
| 110003453 | In distribution | |
| XRAY000162 | In distribution | |
| 010002708 | 40 mm I 10° | In distribution |
| 110004132 | Size I | In distribution |
| SSI005107 | 65mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CS2 Acet. Cup Sys. – VitalitE | Shalby Advanced Technologies, Inc. | 169 |
| iTotal® Hip Replacement System | ConforMIS, Inc. | 131 |
| CS2 Acet. Cup Sys. – VitalitE | Consensus Orthopedics, Inc. | 124 |
| DJO Surgical | Encore Medical, L.P. | 99 |
| MobileLink Acetabular Cup System | Waldemar Link GmbH & Co. KG | 68 |
| Vitelene® | Aesculap AG | 52 |
| Conformis Hip System | ConforMIS, Inc. | 51 |
| Onvoy | Globus Medical, Inc. | 48 |
| Ringloc HIP System | Biomet Orthopedics | 35 |
| Novosource Total Hip System | Novosource, LLC | 33 |
| Prime | Microport Orthopedics Inc. | 32 |
| NovoHip Total Hip System | Novosource, LLC | 28 |
Showing 12 of 100. All products under Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
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.