Novosource Total Hip System
Acetabular Shell, Cluster Hole Sz 68
15manufacturers in China registered for this device type
88catalogue numbers in this listing
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 | Novosource, LLC, 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 | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K132158 |
| Record published | 2018-02-27 |
| Record revised | 2025-07-22 (version 5) |
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 |
| Sizes | Outer diameter 6.5 to 68 mm; lumen/inner diameter 28 to 40 mm; length 15 to 35 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1325-3203 | Outer Diameter 32 mm | In distribution |
| 2200-4628 | Lumen/Inner Diameter 28 mm | In distribution |
| 1100-1375 | Outer Diameter 13.75 mm | In distribution |
| 1325-4003 | Outer Diameter 40 mm | In distribution |
| 1215-5236 | Outer Diameter 52 mm | In distribution |
| 1215-6628 | Outer Diameter 66 mm | In distribution |
| 1204-5840 | Outer Diameter 58 mm | In distribution |
| 1220-0056 | Outer Diameter 56 mm | In distribution |
| 1260-5236 | Outer Diameter 52 mm | In distribution |
| 1300-2804 | Outer Diameter 28 mm | In distribution |
| 1210-0068 | Outer Diameter 68 mm | In distribution |
| 1300-3202 | Outer Diameter 32 mm | In distribution |
| 1125-1125 | Outer Diameter 11.25 mm | In distribution |
| 1325-3603 | Outer Diameter 36 mm | In distribution |
| 1200-0068 | Outer Diameter 68 mm | In distribution |
| 1200-5840 | Outer Diameter 58 mm | In distribution |
| EBS-6535 | Length 35 mm | In distribution |
| 1335-2802 | 16/18-12/14 M | In distribution |
| 1210-0056 | Outer Diameter 56 mm | In distribution |
| 2215-5032 | Outer Diameter 50 mm | In distribution |
| 1100-2250 | Outer Diameter 22.5 mm | In distribution |
| 2200-6640 | Outer Diameter 66 mm | In distribution |
| 1215-5828 | Outer Diameter 58 mm | In distribution |
| 1300-3204 | Outer Diameter 32 mm | In distribution |
| 1204-5828 | Outer Diameter 58 mm | In distribution |
| 1200-0052 | Outer Diameter 52 mm | In distribution |
| 1210-0060 | Outer Diameter 60 mm | In distribution |
| 1204-6628 | Outer Diameter 66 mm | In distribution |
| 2200-5236 | Outer Diameter 52 mm | In distribution |
| 1300-2802 | Outer Diameter 28 mm | In distribution |
| 1310-3200 | Outer Diameter 32 mm | In distribution |
| 1310-4000 | Outer Diameter 40 mm | In distribution |
| 1200-6232 | Outer Diameter 62 mm | In distribution |
| 1200-5828 | Outer Diameter 58 mm | In distribution |
| 1335-2800 | Outer Diameter 28 mm | In distribution |
| EBS-6525 | Length 25 mm | In distribution |
| 1210-0048 | Outer Diameter 48 mm | In distribution |
| 1200-6640 | Outer Diameter 66 mm | In distribution |
| 1204-6640 | Outer Diameter 66 mm | In distribution |
| 1325-2802 | Outer Diameter 28 mm | In distribution |
| 1100-1125 | Outer Diameter 11.25 mm | In distribution |
| 1100-0875 | Outer Diameter 8.75 mm | In distribution |
| 1215-5840 | Outer Diameter 58 mm | In distribution |
| 1125-1775 | Outer Diameter 17.75 mm | In distribution |
| 1325-3201 | Outer Diameter 32 mm | In distribution |
| 2200-5032 | Outer Diameter 50 mm | In distribution |
| 1204-5236 | Outer Diameter 52 mm | In distribution |
| 1200-5236 | Outer Diameter 52 mm | In distribution |
| 1215-6640 | Outer Diameter 66 mm | In distribution |
| 1204-6232 | Outer Diameter 62 mm | In distribution |
| 1220-0064 | Outer Diameter 64 mm | In distribution |
| 1325-3601 | Outer Diameter 36 mm | In distribution |
| 1325-4001 | Outer Diameter 40 mm | In distribution |
| EBS-6515 | Length 15 mm | In distribution |
| 1200-6628 | Outer Diameter 66 mm | In distribution |
| 1125-1375 | Outer Diameter 13.75 mm | In distribution |
| 1220-0052 | Outer Diameter 52 mm | In distribution |
| 1215-5028 | Outer Diameter 50 mm | In distribution |
| 1204-5028 | Outer Diameter 50 mm | In distribution |
| 1200-0048 | Outer Diameter 48 mm | In distribution |
| 2200-5840 | Outer Diameter 58 mm | In distribution |
| 1210-0052 | Outer Diameter 52 mm | In distribution |
| 1200-0056 | Outer Diameter 56 mm | In distribution |
| 1100-0750 | Outer Diameter 7.5 mm | In distribution |
| 1125-0875 | Outer Diameter 8.75 mm | In distribution |
| 1204-5228 | Outer Diameter 52 mm | In distribution |
| 1210-0064 | Outer Diameter 64 mm | In distribution |
| 2215-5236 | Outer Diameter 52 mm | In distribution |
| 1215-5432 | Outer Diameter 54 mm | In distribution |
| 1200-0060 | Outer Diameter 60 mm | In distribution |
| 1335-2804 | 16/18-12/14 XL | In distribution |
| 1200-0064 | Outer Diameter 64 mm | In distribution |
| 1100-1775 | Outer Diameter 17.75 mm | In distribution |
| 1200-5028 | Outer Diameter 50 mm | In distribution |
| 1220-0060 | Outer Diameter 60 mm | In distribution |
| 1125-2250 | Outer Diameter 22.5 mm | In distribution |
| 1200-5228 | Outer Diameter 52 mm | In distribution |
| 1300-3602 | Outer Diameter 36 mm | In distribution |
| 1215-6232 | Outer Diameter 62 mm | In distribution |
| 1220-0068 | Outer Diameter 68 mm | In distribution |
| 1300-4002 | Outer Diameter 40 mm | In distribution |
| 1200-5432 | Outer Diameter 54 mm | In distribution |
| 1215-5228 | Outer Diameter 52 mm | In distribution |
| 1335-3600 | Outer Diameter 36 mm | In distribution |
| 2215-6240 | Outer Diameter 62 mm | In distribution |
| 1300-4004 | Outer Diameter 40 mm | In distribution |
| 1204-5432 | Outer Diameter 54 mm | In distribution |
| 1300-3604 | Outer Diameter 36 mm | 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
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Novosource, LLC | 510(k) number | 2024-09-19 | Class II | Mixed-up of materials/components | Mislabeled: Packaged in a box labeled as 32 long but containing a 28 long head by physical marking, may result in joint instability if implanted | 1 unit |
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.