G7®
61 catalogue numbers from 010002696, listed by Biomet Orthopedics, United States, under Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
61catalogue numbers in this listing
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 | Biomet Orthopedics, United States |
|---|---|
| FDA product code | OQH |
| Device type | Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3350 |
| 510(k) | K121874 |
| Record published | 2021-05-20 |
| 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 |
|---|---|---|
| 010002696 | 32 mm I 10° | In distribution |
| 010002476 | 75 mm | In distribution |
| 110017233 | 28 mm / Size A +5 mm | In distribution |
| 110010309 | SIZE 36MM E | In distribution |
| 010002626 | 32 mm G | In distribution |
| SSI005102 | 55mm | In distribution |
| 010002532 | 28MM, STD NECK LENGTH | In distribution |
| 010002454 | 53 mm | In distribution |
| 010002478 | 77 mm | In distribution |
| 110017261 | SIZE 40MM H | In distribution |
| 110017234 | 28 mm / Size B +5 mm | In distribution |
| 010002605 | 36MM E | In distribution |
| 010002662 | 32 mm I | In distribution |
| 010002727 | 40 mm | In distribution |
| 010002604 | 36MM D | In distribution |
| 010002628 | 32 mm I | In distribution |
| 010002601 | In distribution | |
| SSI005106 | 63mm | In distribution |
| 110017239 | 28 mm Size G / +5 mm | In distribution |
| 010002709 | 40 mm J 10° | In distribution |
| 010002720 | Size H | In distribution |
| 010002515 | 44 mm / +6 mm Neck Length | In distribution |
| 010002613 | 28 mm C | In distribution |
| 010002673 | 40 mm H | In distribution |
| 010002490 | 28MM, -3MM NECK LENGTH | In distribution |
| 010002664 | 36 mm D | In distribution |
| 110002771 | In distribution | |
| 010002615 | 28MM E | In distribution |
| 010002442 | 41 mm | In distribution |
| 010002668 | 36 mm H | In distribution |
| 010002671 | 40 mm F | In distribution |
| 010002683 | 28 mm E 10° | In distribution |
| 010002672 | 40 mm G | In distribution |
| SSI005104 | 59mm | In distribution |
| 010002644 | 44 mm J | In distribution |
| SSI005100 | 51mm | In distribution |
| 010002475 | 74 mm | In distribution |
| SSI005098 | 45mm | In distribution |
| 010002519 | 44MM, -6MM NECK LENGTH | In distribution |
| 010002492 | 32 mm / +12 mm Neck Length | In distribution |
| 110017255 | 36 mm Size G / +5 mm | In distribution |
| 010002648 | 28 mm D | In distribution |
| 010002699 | 36 mm E 10° | In distribution |
| SSI005096 | 41mm | In distribution |
| 010002623 | 32MM D | In distribution |
| 010002698 | 36 mm D 10° | In distribution |
| 110010311 | SIZE 36MM G | In distribution |
| 010002725 | 32 mm | In distribution |
| 110017246 | 32 mm Size E / +5 mm | In distribution |
| 010002478 | 77MM | In distribution |
| 110002770 | In distribution | |
| 010002451 | 50 mm | In distribution |
| 010002479 | 78MM | In distribution |
| 010002531 | 28 mm / +3.5 mm Neck Length | In distribution |
| 010002614 | 28MM D | In distribution |
| 110010721 | In distribution | |
| 110017247 | SIZE 32MM F | In distribution |
| 110004130 | Size A/B | In distribution |
| 010002518 | 44 mm / -3 mm Neck Length | In distribution |
| 010002611 | 28MM A | In distribution |
| 010002711 | 44 mm I 10° | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| G7 Acetabular Liner | Biomet Orthopedics | 41 |
| G7® Longevity® | Zimmer, Inc. | 20 |
| Restoris Xlve | Mako Surgical Corp. | 20 |
| Continuum® Trilogy® Allofit® | Zimmer, Inc. | 17 |
| Arcos® One-piece Revision System | Biomet Orthopedics | 16 |
| G7® Vivacit-E® | Zimmer, Inc. | 15 |
| RingLoc Hip System | Biomet Orthopedics | 15 |
| Continuum® Trilogy® Allofit® Vivacit-E® | Zimmer, Inc. | 14 |
| Restoris | Mako Surgical Corp. | 12 |
| G7® Acetabular System | Biomet Orthopedics | 11 |
| Sirius | Biomet Orthopedics | 7 |
| G7 Osseoti Acetabular Shell | Biomet Orthopedics | 6 |
Showing 12 of 42. All products under Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented
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.