G7®
45 catalogue numbers from 010002504, listed by Biomet Orthopedics, United States, under Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
45catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Jiangsu (2), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| 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 | PBI |
| Device type | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3310 |
| 510(k) | K121874 |
| Record published | 2021-04-16 |
| Record revised | 2025-05-30 (version 9) |
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 |
|---|---|---|
| 010002504 | 36 mm / -3 mm Neck Length | In distribution |
| 010002606 | 36MM F | In distribution |
| 010002721 | Size I | In distribution |
| 010002609 | 36MM I | In distribution |
| 110010306 | SIZE 32MM B | In distribution |
| 110002768 | 28mm-40 mm | In distribution |
| 010002651 | 28 mm G | In distribution |
| 010002479 | 78 mm | In distribution |
| 110017250 | 32 mm Size I / +5 mm | In distribution |
| 110010717 | In distribution | |
| 110017233 | SIZE 28MM A | In distribution |
| 010002448 | 47MM | In distribution |
| 010002692 | 32 mm E 10° | In distribution |
| 110003450 | In distribution | |
| 010002710 | 44 mm H 10° | In distribution |
| 110010301 | SIZE 36MM F | In distribution |
| 010002736 | In distribution | |
| 010002472 | 71 mm | In distribution |
| 010002515 | 44MM, +6MM NECK LENGTH | In distribution |
| SSI005095 | 47mm | In distribution |
| 110017234 | SIZE 28MM B | In distribution |
| 010002496 | 32 mm / Standard Neck Length | In distribution |
| 010002443 | 42 mm | In distribution |
| 010002533 | 28MM, -3.5MM NECK LENGTH | In distribution |
| 010002703 | 36 mm I 10° | In distribution |
| 010002493 | 32 mm / +9 mm Neck Length | In distribution |
| 010002678 | 44 mm J | In distribution |
| 010002633 | 36 mm G | In distribution |
| 010002493 | 32MM, +9MM NECK LENGTH | In distribution |
| 010002495 | 32 mm / +3 mm Neck Length | In distribution |
| 010002503 | 36 mm / Standard Neck Length | In distribution |
| 010002613 | 28MM C | In distribution |
| 110010305 | SIZE 36MM J | In distribution |
| 010002502 | 36MM, +3MM NECK LENGTH | In distribution |
| 010002706 | 40 mm G 10° | In distribution |
| 010002693 | 32 mm F 10° | In distribution |
| 010002502 | 36 mm / +3 mm Neck Length | In distribution |
| 010002505 | 36MM, -6MM NECK LENGTH | In distribution |
| 010002496 | 32MM, STD NECK LENGTH | In distribution |
| 010002612 | 28 mm B | In distribution |
| 010002481 | 80MM | In distribution |
| 110017248 | 32 mm Size G / +5 mm | In distribution |
| 010002465 | 64 mm | In distribution |
| 110017261 | 40 mm Size H / +5 mm | In distribution |
| 110002765 | Size E | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| G7 Acetabular Liner | Biomet Orthopedics | 37 |
| Arcos® One-Piece Revision System | Biomet Orthopedics | 17 |
| G7® Acetabular System | Biomet Orthopedics | 13 |
| G7 Osseoti Acetabular Shell | Biomet Orthopedics | 8 |
| Sirius® | Biomet Orthopedics | 6 |
| G7® Revision Acetabular System | Zimmer, Inc. | 5 |
| G7 Provisional Neutral Liner | Biomet Orthopedics | 4 |
| Echo BI-Metric Microplasty HIP Stem | Biomet Orthopedics | 4 |
| G7® Freedom® Vivacit-E® | Zimmer, Inc. | 4 |
| Sirius HIP System | Biomet Orthopedics | 3 |
| G7 Type 12 / 14 Provisional Head | Biomet Orthopedics | 3 |
| Echo BI-Metric Microplasty HIP System | Biomet Orthopedics | 3 |
Showing 12 of 34. All products under Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer, + Additive
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.