G7® Acetabular System
13 catalogue numbers from 110017101, 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
13catalogue 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) | K142746 |
| Record published | 2015-10-24 |
| Record revised | 2025-05-30 (version 8) |
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, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 110017101 | 48 mm Shell Size Liner Size C | In distribution |
| 110017110 | 66 mm Shell Size Liner Size I | In distribution |
| 110017100 | 46 mm Shell Size Liner Size B | In distribution |
| 110010266 | 56 mm Shell Size Liner Size F | In distribution |
| 110017102 | 50 mm Shell Size Liner Size D | In distribution |
| 110010273 | 70 mm Shell Size Liner Size I | In distribution |
| 110010263 | 50 mm Shell Size Liner Size D | In distribution |
| 110017106 | 58 mm Shell Size Liner Size G | In distribution |
| 110010244 | 52 mm Shell Size Liner Size E | In distribution |
| 110017111 | 68 mm Shell Size Liner Size I | In distribution |
| 010000665 | 56 mm Shell Size Liner Size F | In distribution |
| 010000668 | 62 mm Shell Size Liner Size H | In distribution |
| 010000669 | 64 mm Shell Size Liner Size H | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| G7® | Biomet Orthopedics | 45 |
| G7 Acetabular Liner | Biomet Orthopedics | 37 |
| Arcos® One-Piece Revision System | Biomet Orthopedics | 17 |
| 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.