DJO Surgical
FOUNDATION® HIP SYSTEM Porous, Press Fit Stem Series 470 (12mm)
15manufacturers in China registered for this device type
162catalogue numbers in this listing
3510(k) clearances naming this product code
1recall
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 | Encore Medical, L.P., 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 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K083651 |
| Record published | 2017-08-07 |
| Record revised | 2020-12-15 (version 14) |
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 |
|---|---|---|
| 427-44-180 | In distribution | |
| 402-03-444 | In distribution | |
| 425-99-008 | In distribution | |
| 426-12-080 | In distribution | |
| 425-01-014 | In distribution | |
| 425-98-008 | In distribution | |
| 425-01-009 | In distribution | |
| 425-98-014 | In distribution | |
| 402-03-403 | In distribution | |
| 495-15-170 | In distribution | |
| 402-03-442 | In distribution | |
| 400-03-363 | In distribution | |
| 495-00-275 | In distribution | |
| 402-04-400 | In distribution | |
| 427-40-120 | In distribution | |
| 400-05-007 | In distribution | |
| 425-11-008 | In distribution | |
| 400-03-322 | In distribution | |
| 425-99-011 | In distribution | |
| 425-93-015 | In distribution | |
| 400-03-364 | In distribution | |
| 470-01-105 | In distribution | |
| 400-03-404 | In distribution | |
| 427-40-135 | In distribution | |
| 400-03-443 | In distribution | |
| 427-40-165 | In distribution | |
| 400-05-000 | In distribution | |
| 425-99-015 | In distribution | |
| 427-43-120 | In distribution | |
| 400-03-282 | In distribution | |
| 402-03-404 | In distribution | |
| 402-04-440 | In distribution | |
| 425-98-012 | In distribution | |
| 425-99-009 | In distribution | |
| 495-24-210 | In distribution | |
| 470-01-165 | In distribution | |
| 425-01-008 | In distribution | |
| 402-03-364 | In distribution | |
| 425-11-015 | In distribution | |
| 400-03-321 | In distribution | |
| 402-03-362 | In distribution | |
| 425-99-012 | In distribution | |
| 427-40-150 | In distribution | |
| 480-01-150 | In distribution | |
| 495-28-210 | In distribution | |
| 425-91-007 | In distribution | |
| 400-03-362 | In distribution | |
| 425-92-021 | In distribution | |
| 425-91-009 | In distribution | |
| 425-01-015 | In distribution | |
| 425-11-009 | In distribution | |
| 425-99-006 | In distribution | |
| 400-03-441 | In distribution | |
| 425-11-019 | In distribution | |
| 400-05-004 | In distribution | |
| 402-03-441 | In distribution | |
| 425-01-006 | In distribution | |
| 470-01-120 | In distribution | |
| 402-03-323 | In distribution | |
| 400-03-283 | In distribution | |
| 480-01-080 | In distribution | |
| 425-01-010 | In distribution | |
| 400-03-442 | In distribution | |
| 425-93-010 | In distribution | |
| 400-03-281 | In distribution | |
| 402-05-300 | In distribution | |
| 425-98-016 | In distribution | |
| 425-01-012 | In distribution | |
| 480-01-135 | In distribution | |
| 400-03-324 | In distribution | |
| 425-11-010 | In distribution | |
| 425-41-012 | In distribution | |
| 425-98-009 | In distribution | |
| 495-00-065 | In distribution | |
| 425-99-010 | In distribution | |
| 402-03-283 | In distribution | |
| 470-01-135 | In distribution | |
| 400-03-444 | In distribution | |
| 425-91-012 | In distribution | |
| 495-18-170 | In distribution | |
| 425-98-007 | In distribution | |
| 480-01-165 | In distribution | |
| 425-92-008 | In distribution | |
| 400-03-401 | In distribution | |
| 400-03-402 | In distribution | |
| 427-43-165 | In distribution | |
| 470-01-090 | In distribution | |
| 425-01-011 | In distribution | |
| 402-03-401 | In distribution | |
| 402-04-280 | In distribution | |
| 425-01-005 | In distribution | |
| 425-41-007 | In distribution | |
| 425-98-005 | In distribution | |
| 470-01-150 | In distribution | |
| 402-03-282 | In distribution | |
| 480-01-090 | In distribution | |
| 402-03-321 | In distribution | |
| 425-11-014 | In distribution | |
| 400-04-440 | In distribution | |
| 495-20-130 | In distribution | |
| 402-03-324 | In distribution | |
| 425-91-008 | In distribution | |
| 425-99-005 | In distribution | |
| 425-01-007 | In distribution | |
| 402-04-360 | In distribution | |
| 425-98-013 | In distribution | |
| 425-11-011 | In distribution | |
| 425-99-016 | In distribution | |
| 425-01-013 | In distribution | |
| 400-04-280 | In distribution | |
| 425-98-015 | In distribution | |
| 425-31-007 | In distribution | |
| 402-03-402 | In distribution | |
| 495-16-170 | In distribution | |
| 425-92-012 | In distribution | |
| 425-99-019 | In distribution | |
| 400-04-360 | In distribution | |
| 425-11-012 | In distribution | |
| 402-03-361 | In distribution | |
| 425-01-016 | In distribution | |
| 402-03-322 | In distribution | |
| 425-99-007 | In distribution | |
| 495-20-210 | In distribution | |
| 480-01-105 | In distribution | |
| 402-03-281 | In distribution | |
| 400-03-361 | In distribution | |
| 400-03-403 | In distribution | |
| 400-03-323 | In distribution | |
| 402-05-007 | In distribution | |
| 425-91-005 | In distribution | |
| 425-99-014 | In distribution | |
| 425-98-017 | In distribution | |
| 425-11-016 | In distribution | |
| 425-11-017 | In distribution | |
| 470-01-080 | In distribution | |
| 400-04-320 | In distribution | |
| 427-33-150 | In distribution | |
| 425-11-007 | In distribution | |
| 427-30-165 | In distribution | |
| 425-31-009 | In distribution | |
| 425-11-006 | In distribution | |
| 425-98-006 | In distribution | |
| 400-05-300 | In distribution | |
| 402-04-320 | In distribution | |
| 425-98-011 | In distribution | |
| 425-98-010 | In distribution | |
| 470-01-180 | In distribution | |
| 402-05-000 | In distribution | |
| 425-11-005 | In distribution | |
| 425-93-008 | In distribution | |
| 402-03-363 | In distribution | |
| 425-99-013 | In distribution | |
| 427-34-165 | In distribution | |
| 402-03-443 | In distribution | |
| 425-99-017 | In distribution | |
| 427-34-150 | In distribution | |
| 480-01-120 | In distribution | |
| 425-01-017 | In distribution | |
| 425-31-016 | In distribution | |
| 400-04-400 | In distribution | |
| 402-05-004 | In distribution | |
| 425-11-013 | 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 |
| 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 |
| RingLoc® Hip System | Biomet Orthopedics | 130 |
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 |
|---|---|
| K241483 | 2025-02-07 |
| K082844 | 2008-11-25 |
| K082398 | 2008-10-15 |
Recalls Naming This Product
4 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 | 10 | |
| 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 | 2018-09-21 | Class II | Other | Complaints regarding loose proximal body bolts or bolts that were found through x-ray as sitting above the proximal body and not properly seated. Patient risks may include: pain, dissociation, and possible revision surgery | 22 | 2020-09-16 |
| Encore Medical, L.P. | 510(k) number | 2018-07-10 | Class II | Process design | The retaining ring on the neck trials has a potential to fail interoperatively. | 28 (14 REF S200635 and 14 S200636) |
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.