DJO Surgical
Shell, Bipolar, Modular, Encore, SIZE41
14manufacturers in China registered for this device type
11catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (7), 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 |
| 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 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
Showing 12 of 14. All 14 manufacturers in China registered for Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Record
| Listed by | DJO, LLC, United States |
|---|---|
| FDA product code | KWY |
| Device type | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3390 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K953510 |
| Record published | 2016-05-25 |
| Record revised | 2020-04-06 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 412-01-046 | In distribution | |
| 412-01-042 | In distribution | |
| 412-01-053 | In distribution | |
| 412-01-054 | In distribution | |
| 412-01-050 | In distribution | |
| 412-02-041 | In distribution | |
| 412-01-051 | In distribution | |
| 412-01-056 | In distribution | |
| 412-01-044 | In distribution | |
| 412-01-048 | In distribution | |
| 412-01-052 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Resolve Modular Revision Hip Stem | United Orthopedic Corp. | 196 |
| Corin Bipolar Prosthesis | Corin Limited | 182 |
| Consensus® Hip System | Consensus Orthopedics, Inc. | 177 |
| Consensus Hip System | Shalby Advanced Technologies, Inc. | 177 |
| Instrument | Howmedica Osteonics Corp | 130 |
| Bencox Hip System | Corentec Co., Ltd. | 126 |
| United Hip System, U2 Bipolar Implant | United Orthopedic Corp. | 123 |
| MultiPolar® | Zimmer, Inc. | 100 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | Zimmer, Inc. | 96 |
| Fitmore® Hip Stem | Zimmer, Inc. | 75 |
| Arcos® Modular Revision System | Biomet Orthopedics | 67 |
| Acumatch L-Series | Exactech, Inc. | 67 |
Showing 12 of 352. All products under Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Recalls Naming This Product
18 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 | 2007-08-02 | Not classified | Packaging change control | Device mislabeled. Hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date. | 76 units. | 2008-01-09 |
| Encore Medical, L.P. | 510(k) number | 2007-08-02 | Not classified | Packaging change control | Device mislabeled. Hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date. | 111 units. | 2008-01-09 |
| Encore Medical, L.P. | 510(k) number | 2007-08-02 | Not classified | Packaging change control | Device mislabeled. Hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date. | 382 units. | 2008-01-09 |
| Encore Medical, L.P. | 510(k) number | 2007-08-02 | Not classified | Packaging change control | Device mislabeled. Hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date. | 479 units. | 2008-01-09 |
| Encore Medical, L.P. | 510(k) number | 2007-08-02 | Not classified | Packaging change control | Device mislabeled. Hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date. | 776 units. | 2008-01-09 |
| Encore Medical, L.P. | 510(k) number | 2007-08-02 | Not classified | Packaging change control | Device mislabeled; hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date. | 632 units. | 2008-01-09 |
| Encore Medical, L.P. | 510(k) number | 2007-08-02 | Not classified | Packaging change control | Device mislabeled; hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date. | 605 units. | 2008-01-09 |
| Encore Medical, L.P. | 510(k) number | 2007-08-02 | Not classified | Packaging change control | Device mislabeled; hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date. | 478 units. | 2008-01-09 |
| Encore Medical, L.P. | 510(k) number | 2007-08-02 | Not classified | Packaging change control | Device mislabeled; hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date. | 377 units. | 2008-01-09 |
| Encore Medical, L.P. | 510(k) number | 2007-08-02 | Not classified | Packaging change control | Device mislabeled; hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date. | 304 units. | 2008-01-09 |
| Encore Medical, L.P. | 510(k) number | 2007-08-02 | Not classified | Packaging change control | Device mislabeled; hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date. | 225 units. | 2008-01-09 |
| Encore Medical, L.P. | 510(k) number | 2007-08-02 | Not classified | Packaging change control | Device mislabeled; hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date. | 185 units. | 2008-01-09 |
| Encore Medical, L.P. | 510(k) number | 2007-08-02 | Not classified | Packaging change control | Device mislabeled; hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date. | 171 units. | 2008-01-09 |
| Encore Medical, L.P. | 510(k) number | 2007-08-02 | Not classified | Packaging change control | Device mislabeled; hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date. | 137 units. | 2008-01-09 |
| Encore Medical, L.P. | 510(k) number | 2007-08-02 | Not classified | Packaging change control | Device mislabeled; hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date. | 137 units. | 2008-01-09 |
| Encore Medical, L.P. | 510(k) number | 2007-08-02 | Not classified | Packaging change control | Device mislabeled; hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date. | 86 units. | 2008-01-09 |
| Encore Medical, L.P. | 510(k) number | 2007-08-02 | Not classified | Packaging change control | Device mislabeled; hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date. | 2008-01-09 | |
| Encore Medical, L.P. | 510(k) number | 2007-08-02 | Not classified | Packaging change control | Device mislabeled; hip prosthesis components validated for 5 years were labeled as having a 6 year expiration date. | 13 units. | 2008-01-09 |
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.