DJO Surgical
HIP, Stem, CLP, Revision, SIZE#12, Implant, Polished Neck
4manufacturers in China registered for this device type
48catalogue numbers in this listing
5510(k) clearances naming this product code
2recalls on this code
Who Else Makes It
Concentrated in Shanghai (2), Zhejiang (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
Record
| Listed by | Encore Medical, L.P., United States |
|---|---|
| FDA product code | KWA |
| Device type | Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) |
| Device class | Class 3 |
| Regulation | 21 CFR 888.3330 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K092331 |
| Record published | 2017-08-07 |
| Record revised | 2024-06-27 (version 5) |
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 |
|---|---|---|
| 428-24-200 | In distribution | |
| 428-00-110 | In distribution | |
| 428-00-080 | In distribution | |
| 427-04-120 | In distribution | |
| 428-00-050 | In distribution | |
| 428-16-140 | In distribution | |
| 427-43-150 | In distribution | |
| 428-00-060 | In distribution | |
| 427-43-090 | In distribution | |
| 428-00-070 | In distribution | |
| 428-16-200 | In distribution | |
| 428-24-140 | In distribution | |
| 428-18-200 | In distribution | |
| 426-12-090 | In distribution | |
| 428-01-090 | In distribution | |
| 426-12-060 | In distribution | |
| 427-30-105 | In distribution | |
| 428-18-140 | In distribution | |
| 427-43-135 | In distribution | |
| 427-34-105 | In distribution | |
| 426-12-120 | In distribution | |
| 428-22-140 | In distribution | |
| 428-22-200 | In distribution | |
| 427-04-150 | In distribution | |
| 427-33-105 | In distribution | |
| 427-03-080 | In distribution | |
| 428-01-060 | In distribution | |
| 427-33-080 | In distribution | |
| 428-01-100 | In distribution | |
| 428-01-070 | In distribution | |
| 427-40-090 | In distribution | |
| 428-14-200 | In distribution | |
| 428-01-080 | In distribution | |
| 428-20-140 | In distribution | |
| 428-01-110 | In distribution | |
| 427-33-180 | In distribution | |
| 426-12-100 | In distribution | |
| 427-44-135 | In distribution | |
| 428-00-090 | In distribution | |
| 426-12-010 | In distribution | |
| 428-20-200 | In distribution | |
| 427-33-165 | In distribution | |
| 427-43-180 | In distribution | |
| 427-44-105 | In distribution | |
| 428-00-100 | In distribution | |
| 428-01-050 | In distribution | |
| 427-30-135 | In distribution | |
| 428-14-140 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Conserve® | Microport Orthopedics Inc. | 24 |
| RingLoc+ Hip System | Biomet Orthopedics | 21 |
| Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | Zimmer, Inc. | 17 |
| Fitmore® Hip Stem | Zimmer, Inc. | 17 |
| Dynasty | Microport Orthopedics Inc. | 12 |
| Asphere | Depuy (Ireland) | 10 |
| Taperloc Complete Micro Primary Femoral | Biomet Orthopedics | 9 |
| Arcos Modular Revision Hip System | Biomet Orthopedics | 7 |
| Kinectiv® | Zimmer, Inc. | 7 |
| M2A – Modular Head HIP System | Biomet Orthopedics | 6 |
| Transcend® | Microport Orthopedics Inc. | 5 |
| Biolox Delta | Depuy Orthopaedics, Inc. | 4 |
Showing 12 of 20. All products under Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K092331 | 2010-03-03 |
| K083651 | 2009-03-13 |
| K070221 | 2007-04-04 |
| K063414 | 2006-12-12 |
| K040354 | 2004-11-04 |
Recalls Naming This Product
2 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 | 2017-01-10 | Class II | Nonconforming Material/Component | Lima Proximal Bodies were inadvertently re-sterilized. The safety screw which affixes the distal and proximal bodies of the stem includes a thread-locking plug made from UHMWPE, which is not approved for repeated gamma sterilization. | 13 devices | 2017-03-31 |
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.