Mallory/Head Calcar HIP System
18 catalogue numbers from 11-104915, 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
18catalogue 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) | K031693 |
| Record published | 2015-10-24 |
| Record revised | 2025-05-30 (version 6) |
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 |
|---|---|---|
| 11-104915 | 55 – 65 MM | In distribution |
| 108155 | 55C SIZE TYPE1 TAPER | In distribution |
| 11-104913 | 60 – 70 MM | In distribution |
| 108115 | 34C SIZE TYPE1 TAPER | In distribution |
| 11-135162 | 13 SIZE 165 MM | In distribution |
| 108159 | 55E SIZE TYPE1 TAPER | In distribution |
| 11-105009 | 60 – 70 MM | In distribution |
| 11-105007 | 50 – 60 MM | In distribution |
| 11-105021 | LARGE SIZE 73 MM | In distribution |
| 11-135165 | 16 SIZE 165 MM | In distribution |
| CP155932 | 13.0 MM 170 MM | In distribution |
| 11-135169 | 20 SIZE 165 MM | In distribution |
| 11-105020 | MEDIUM SIZE 53 MM | In distribution |
| 11-135164 | 15 SIZE 165 MM | In distribution |
| 108117 | 34D SIZE TYPE1 TAPER | In distribution |
| 11-104910 | In distribution | |
| 11-135160 | 11 SIZE 165 MM | In distribution |
| 108139 | 45E SIZE 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
16 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 | 2010-03-10 | Not classified | Process change control | The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep. | 3 | 2010-10-18 |
| Biomet, Inc. | 510(k) number | 2010-03-10 | Not classified | Process change control | The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep. | 6 | 2010-10-18 |
| Biomet, Inc. | 510(k) number | 2010-03-10 | Not classified | Process change control | The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep. | 10 | 2010-10-18 |
| Biomet, Inc. | 510(k) number | 2010-03-10 | Not classified | Process change control | The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep. | 6 | 2010-10-18 |
| Biomet, Inc. | 510(k) number | 2010-03-10 | Not classified | Process change control | The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep. | 21 | 2010-10-18 |
| Biomet, Inc. | 510(k) number | 2010-03-10 | Not classified | Process change control | The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep. | 5 | 2010-10-18 |
| Biomet, Inc. | 510(k) number | 2010-03-10 | Not classified | Process change control | The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep. | 6 | 2010-10-18 |
| Biomet, Inc. | 510(k) number | 2010-03-10 | Not classified | Process change control | The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep. | 6 | 2010-10-18 |
| Biomet, Inc. | 510(k) number | 2010-03-10 | Not classified | Process change control | The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep. | 6 | 2010-10-18 |
| Biomet, Inc. | 510(k) number | 2010-03-10 | Not classified | Process change control | The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep. | 6 | 2010-10-18 |
| Biomet, Inc. | 510(k) number | 2010-03-10 | Not classified | Process change control | The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep. | 6 | 2010-10-18 |
| Biomet, Inc. | 510(k) number | 2010-03-10 | Not classified | Process change control | The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep. | 11 | 2010-10-18 |
| Biomet, Inc. | 510(k) number | 2010-03-10 | Not classified | Process change control | The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep. | 4 | 2010-10-18 |
| Biomet, Inc. | 510(k) number | 2010-03-10 | Not classified | Process change control | The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep. | 3 | 2010-10-18 |
| Biomet, Inc. | 510(k) number | 2010-03-10 | Not classified | Process change control | The firm has found that some lots of Mallory Head Revision Stems had flute geometry that was out of specification. The flute geometry was too deep. | 6 | 2010-10-18 |
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.