Biomet® Hip System
15 catalogue numbers from 163626, listed by Biomet Orthopedics, United States, under Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer. 7 manufacturers in China are registered for this product code.
7manufacturers in China registered for this device type
15catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (2), Zhejiang (2). 4 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 |
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| 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 | KRO |
| Device type | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3510 |
| 510(k) | K974558 |
| Record published | 2019-02-15 |
| Record revised | 2025-05-30 (version 5) |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 163626 | 26mm Ø Type1 Taper | In distribution |
| 163638 | 28mm Ø Type1 Taper | In distribution |
| 163621 | 26mm Ø Type1 Taper | In distribution |
| 163627 | 26mm Ø Type1 Taper | In distribution |
| 163662 | 28mm Ø Type1 Taper | In distribution |
| 163622 | 26MM Ø TYPE1 TAPER | In distribution |
| 163665 | 28mm Ø Type1 Taper | In distribution |
| 163626 | 26MM Ø TYPE1 TAPER | In distribution |
| 163653 | 22mm Ø Type1 Taper | In distribution |
| 163674 | 32mm Ø Type1 Taper | In distribution |
| 163622 | 26mm Ø Type1 Taper | In distribution |
| 163662 | 28mm Ø Type1 Taper | In distribution |
| 163625 | 26mm Ø Type1 Taper | In distribution |
| 163637 | 28MM Ø TYPE1 TAPER | In distribution |
| 163624 | 26mm Ø Type1 Taper | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Link Endo-Model EVO Knee System | Waldemar Link GmbH & Co. KG | 324 |
| Endo-Model Modular Knee Prosthesis System | Waldemar Link GmbH & Co. KG | 291 |
| LinkSymphoKnee | Waldemar Link GmbH & Co. KG | 263 |
| Evolution | Microport Orthopedics Inc. | 223 |
| Legion | Smith & Nephew, Inc. | 222 |
| OSS™ Orthopedic Salvage System | Biomet Orthopedics | 211 |
| Ustar II Knee System | United Orthopedic Corp. | 185 |
| “united” Ustar II Knee System | United Orthopedic Corp. | 162 |
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | Zimmer, Inc. | 157 |
| Finn Knee System | Biomet Orthopedics | 138 |
| NexGen | Zimmer, Inc. | 119 |
| Triathlon | Howmedica Osteonics Corp | 106 |
Showing 12 of 109. All products under Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K131393 | 2013-10-24 |
| K020381 | 2002-05-06 |
Recalls Naming This Product
14 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 |
|---|---|---|---|---|---|---|---|
| Biomet, Inc. | 510(k) number | 2020-11-25 | Class II | Process control | Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device. | 7428 | 2024-05-08 |
| Biomet, Inc. | 510(k) number | 2018-04-02 | Class II | Nonconforming Material/Component | Two lots of different sized modular heads potentially commingled. Risks include delay in surgery and dislocation due to use of an incorrect sized head. | 30 | 2020-05-12 |
| Biomet, Inc. | 510(k) number | 2015-11-17 | Class II | Labeling Change Control | PMMA is listed as a material on the label but the product does not contain PMMA. | 21 | 2016-07-05 |
| Biomet, Inc. | 510(k) number | 2015-04-16 | Class III | Labeling mix-ups | Biomet hip joint, knee joint and shoulder joint replacement components device labeling contains incorrect GTIN (Global Trade Identification Number) codes. | 1315 | 2016-05-16 |
| Biomet, Inc. | 510(k) number | 2003-06-18 | Not classified | Other | The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place. | 16 | 2003-09-23 |
| Biomet, Inc. | 510(k) number | 2003-06-18 | Not classified | Other | The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place. | 5 | 2003-09-23 |
| Biomet, Inc. | 510(k) number | 2003-06-18 | Not classified | Other | The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place. | 12 | 2003-09-23 |
| Biomet, Inc. | 510(k) number | 2003-06-18 | Not classified | Other | The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place. | 33 | 2003-09-23 |
| Biomet, Inc. | 510(k) number | 2003-06-18 | Not classified | Other | The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place. | 30 | 2003-09-23 |
| Biomet, Inc. | 510(k) number | 2003-06-18 | Not classified | Other | The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place. | 28 | 2003-09-23 |
| Biomet, Inc. | 510(k) number | 2003-06-18 | Not classified | Other | The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place. | 16 | 2003-09-23 |
| Biomet, Inc. | 510(k) number | 2003-06-18 | Not classified | Other | The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place. | 25 | 2003-09-23 |
| Biomet, Inc. | 510(k) number | 2003-06-18 | Not classified | Other | The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place. | 35 | 2003-09-23 |
| Biomet, Inc. | 510(k) number | 2003-06-18 | Not classified | Other | The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place. | 31 | 2003-09-23 |
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.