Mallory/Head Interlok HIP System
6 catalogue numbers from 105615, listed by Biomet Orthopedics, United States, under Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented. 13 manufacturers in China are registered for this product code.
13manufacturers in China registered for this device type
6catalogue numbers in this listing
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (6), Shanghai (3), Zhejiang (2). 9 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 |
| Canwell Medical Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 42 |
| Suzhou Elite Precision Machinery Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 35 |
| B-ONE Medical (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Stryker (Suzhou) Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Xian Airfoil Technology Co., Ltd. | Xian | Shaanxi | Contract manufacturer | 8 |
| b-ONE Medical (Beijing) Co., Ltd. | Beijing | Beijing | 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 |
Showing 12 of 13. All 13 manufacturers in China registered for Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Record
| Listed by | Biomet Orthopedics, United States |
|---|---|
| FDA product code | JDI |
| Device type | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3350 |
| 510(k) | K911684 |
| Record published | 2015-10-24 |
| 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 |
|---|---|---|
| 105615 | 15 SIZE 180 MM TYPE1 TAPER | In distribution |
| 105613 | 13 SIZE 170 MM TYPE1 TAPER | In distribution |
| 105609 | 9 SIZE 150 MM TYPE1 TAPER | In distribution |
| 105611 | 11 SIZE 160 MM TYPE1 TAPER | In distribution |
| 105607 | 7 SIZE 140 MM TYPE1 TAPER | In distribution |
| 105606 | 5/7 SIZE 135 MM TYPE1 TAPER | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Zimmer, Inc. | 836 |
| R3 | Smith & Nephew, Inc. | 497 |
| UniSyn Hip System | Shalby Advanced Technologies, Inc. | 247 |
| UniSyn® Hip System | Consensus Orthopedics, Inc. | 247 |
| Reflection | Smith & Nephew, Inc. | 170 |
| Instrument | Howmedica Osteonics Corp | 167 |
| Echelon | Smith & Nephew, Inc. | 159 |
| B-P Total HIP System | Endotec, Inc. | 151 |
| ZCA® | Zimmer, Inc. | 149 |
| Omnifit | Howmedica Osteonics Corp | 149 |
| Ringloc HIP System | Biomet Orthopedics | 139 |
| Profemur | Microport Orthopedics Inc. | 113 |
Showing 12 of 444. All products under Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253515 | 2026-08-24 |
| K023085 | 2002-10-17 |
| K020076 | 2002-01-30 |
Recalls Naming This Product
12 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 | 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 | 2015-04-16 | 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.