Biolox® Delta Hip System
28 catalogue numbers from 650-1056, listed by Biomet Orthopedics, United States, under Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented. 15 manufacturers in China are registered for this product code.
15manufacturers in China registered for this device type
28catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (8), Shanghai (3), Zhejiang (2). 10 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 |
| Lincotek (Wuxi) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 7 |
| 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 |
Showing 12 of 15. All 15 manufacturers in China registered for Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Record
| Listed by | Biomet Orthopedics, United States |
|---|---|
| FDA product code | LZO |
| Device type | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3353 |
| 510(k) | K082996 |
| Record published | 2018-11-13 |
| 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 |
|---|---|---|
| 650-1056 | Type 16/18 Taper 32mm Head Ø | In distribution |
| 12-115122 | 36 HEAD Ø TYPE I TAPER | In distribution |
| 12-115123 | 36 HEAD Ø TYPE I TAPER | In distribution |
| 12-115114 | 32 HEAD Ø TYPE I TAPER | In distribution |
| 12-115116 | 32 HEAD Ø TYPE I TAPER | In distribution |
| 12-115122 | Type I Taper 36mm Head Ø | In distribution |
| 650-1058 | 40 HEAD Ø TYPE 16/18 TAPER | In distribution |
| 12-115111 | Type I Taper 28mm Head Ø | In distribution |
| 12-115115 | Type I Taper 32mm Head Ø | In distribution |
| 650-1056 | 32 HEAD Ø TYPE 16/18 TAPER | In distribution |
| 12-115109 | Type I Taper 28mm Head Ø | In distribution |
| 12-115120 | Type I Taper 36mm Head Ø | In distribution |
| 12-115117 | 32 HEAD Ø TYPE I TAPER | In distribution |
| 12-115123 | Type I Taper 36mm Head Ø | In distribution |
| 12-115120 | 36 HEAD Ø TYPE I TAPER | In distribution |
| 12-115117 | Type I Taper 32mm Head Ø | In distribution |
| 12-115114 | Type I Taper 32mm Head Ø | In distribution |
| 12-115110 | 28 HEAD Ø TYPE I TAPER | In distribution |
| 650-1057 | 36 HEAD Ø TYPE 16/18 TAPER | In distribution |
| 650-1057 | Type 16/18 Taper 36mm Head Ø | In distribution |
| 12-115121 | 36 HEAD Ø TYPE I TAPER | In distribution |
| 12-115116 | Type I Taper 32mm Head Ø | In distribution |
| 12-115115 | 32 HEAD Ø TYPE I TAPER | In distribution |
| 650-1058 | Type 16/18 Taper 40mm Head Ø | In distribution |
| 12-115109 | 28 HEAD Ø TYPE I TAPER | In distribution |
| 12-115111 | 28 HEAD Ø TYPE I TAPER | In distribution |
| 12-115110 | Type I Taper 28mm Head Ø | In distribution |
| 12-115121 | Type I Taper 36mm Head Ø | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Libertas | Maxx Orthopedics Inc. | 1,832 |
| Redapt | Smith & Nephew, Inc. | 326 |
| Bencox Hip System | Corentec Co., Ltd. | 295 |
| M-Vizion Femoral Revision System | Medacta International SA | 289 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Zimmer, Inc. | 280 |
| Profemur® | Microport Orthopedics Inc. | 229 |
| DJO Surgical | Encore Medical, L.P. | 162 |
| Instrument | Howmedica Osteonics Corp | 152 |
| Alteon | Exactech, Inc. | 151 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Exactech, Inc. | 136 |
| Resolve Modular Revision Hip Stem | United Orthopedic Corp. | 136 |
| Wagner SL Revision® | Zimmer, Inc. | 133 |
Showing 12 of 691. All products under Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K200196 | 2020-12-08 |
Recalls Naming This Product
7 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 | 2024-08-08 | Class II | Under Investigation by firm | Mislabeled: Incorrect sleeve in the packaging. The outer packaging is labeled as a standard neck sleeve, however, the product within the box is a -6mm neck sleeve, and vice versa. The neck of the sleeve can be identified by the device etchi | 69 units | |
| Zimmer, Inc. | 510(k) number | 2024-08-08 | Class II | Under Investigation by firm | Mislabeled: Incorrect sleeve in the packaging. The outer packaging is labeled as a standard neck sleeve, however, the product within the box is a -6mm neck sleeve, and vice versa. The neck of the sleeve can be identified by the device etchi | 58 units | |
| Biomet, Inc. | 510(k) number | 2020-04-17 | Class II | Process control | Potential presence of elevated endotoxin levels that exceed the specification limit | 58 units | 2021-06-25 |
| Biomet, Inc. | 510(k) number | 2017-06-05 | Class II | Labeling False and Misleading | Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect. | 2018-03-06 | |
| Biomet, Inc. | 510(k) number | 2017-06-05 | Class II | Labeling False and Misleading | Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect. | 2018-03-06 | |
| Biomet, Inc. | 510(k) number | 2009-03-16 | Not classified | Process control | The firm has received reports of fractured heads, requiring revision surgery. | 174 | 2010-10-06 |
| Biomet, Inc. | 510(k) number | 2009-03-16 | Not classified | Process control | The firm has received reports of fractured heads, requiring revision surgery. | 161 | 2010-10-06 |
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.