DJO Surgical
HIP, Stem, CLP, Standard, SIZE#12, Implant, Polished Neck
13manufacturers in China registered for this device type
42catalogue numbers in this listing
7recalls on this 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 | Encore Medical, L.P., United States |
|---|---|
| FDA product code | JDI |
| Device type | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3350 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K052320 |
| Record published | 2017-08-07 |
| Record revised | 2020-12-29 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 426-12-030 | In distribution | |
| 426-10-120 | In distribution | |
| 426-10-060 | In distribution | |
| 400-01-223 | In distribution | |
| 440-00-150 | In distribution | |
| 440-01-105 | In distribution | |
| 400-32-800 | In distribution | |
| 497-36-000 | In distribution | |
| 400-01-222 | In distribution | |
| 440-01-150 | In distribution | |
| 440-01-120 | In distribution | |
| 440-01-090 | In distribution | |
| 400-32-120 | In distribution | |
| 440-00-120 | In distribution | |
| 426-10-000 | In distribution | |
| 410-35-108 | In distribution | |
| 400-01-221 | In distribution | |
| 400-32-004 | In distribution | |
| 426-10-020 | In distribution | |
| 426-10-040 | In distribution | |
| 426-10-010 | In distribution | |
| 426-10-001 | In distribution | |
| 440-00-090 | In distribution | |
| 410-38-108 | In distribution | |
| 440-01-165 | In distribution | |
| 426-10-030 | In distribution | |
| 426-10-050 | In distribution | |
| 426-10-090 | In distribution | |
| 440-00-135 | In distribution | |
| 410-32-108 | In distribution | |
| 440-01-135 | In distribution | |
| 400-32-000 | In distribution | |
| 426-12-070 | In distribution | |
| 410-38-112 | In distribution | |
| 426-10-110 | In distribution | |
| 440-00-165 | In distribution | |
| 426-10-070 | In distribution | |
| 400-32-400 | In distribution | |
| 497-28-350 | In distribution | |
| 426-10-080 | In distribution | |
| 440-00-105 | In distribution | |
| 426-10-100 | 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
Recalls Naming This Product
6 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 |
|---|---|---|---|---|---|---|---|
| Encore Medical, L.P. | 510(k) number | 2023-08-04 | Class II | Nonconforming Material/Component | Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to revision surgery | 0 | |
| Encore Medical, L.P. | 510(k) number | 2008-05-08 | Not classified | Nonconforming Material/Component | Product not manufactured to specifications; modular femoral necks found to contain 24 scallops, instead of the standard 12. | 20 units | 2009-09-08 |
| Encore Medical, L.P. | 510(k) number | 2007-04-12 | Not classified | Other | Sterility/Package Integrity : Device packaging may potentially be unable to ensure sterility when exposed to shipping conditions. | 3 units. | 2007-07-25 |
| Encore Medical, L.P. | 510(k) number | 2007-04-12 | Not classified | Other | Sterility/Package Integrity : Device packaging may potentially be unable to ensure sterility when exposed to shipping conditions. | 3 units. | 2007-07-25 |
| Encore Medical, L.P. | 510(k) number | 2007-04-12 | Not classified | Other | Sterility/Package Integrity: Device packaging may potentially be unable to ensure sterility when exposed to shipping conditions. | 2 units. | 2007-07-25 |
| Encore Medical, L.P. | 510(k) number | 2007-04-12 | Not classified | Other | Sterility/Package Integrity: Device packaging may potentially be unable to ensure sterility when exposed to shipping conditions. | 2 units. | 2007-07-25 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2011-08-17 | Not classified | Packaging | The sterility has the potential to be compromised. | 169 units | 2012-05-11 |
| 2004-06-30 | Not classified | Other | Hip stem product was mis-labeled with wrong size. | 3 units | 2004-10-21 |
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.