Novosource Total Hip System
Liner, Elevated Face Sz 54/56 x36
8manufacturers in China registered for this device type
33catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Shanghai (3), Jiangsu (3), Zhejiang (1). 4 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 |
| APS Materials Suzhou | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Lincotek (Wuxi) Co., Ltd. | Wuxi | Jiangsu | 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 |
| Shenzhen Fox Hunting E-commerce Co., Ltd. | Shenzhen | Guangdong | Exporter | 7 |
Record
| Listed by | Novosource, LLC, United States |
|---|---|
| FDA product code | OQG |
| Device type | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3358 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K140701 |
| Record published | 2018-02-27 |
| Record revised | 2025-07-22 (version 4) |
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 | Lumen/inner diameter 28 to 40 mm; outer diameter 46 to 66 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1200-5832 | Lumen/Inner Diameter 32 mm | In distribution |
| 1280-5436 | Lumen/Inner Diameter 36 mm | In distribution |
| 1215-4628 | Lumen/Inner Diameter 28 mm | In distribution |
| 1215-6228 | Lumen/Inner Diameter 28 mm | In distribution |
| 1280-6236 | Lumen/Inner Diameter 36 mm | In distribution |
| 1215-5832 | Lumen/Inner Diameter 32 mm | In distribution |
| 1215-5428 | Lumen/Inner Diameter 28 mm | In distribution |
| 1280-5236 | Lumen/Inner Diameter 36 mm | In distribution |
| 1215-5436 | Lumen/Inner Diameter 36 mm | In distribution |
| 1215-5232 | Lumen/Inner Diameter 32 mm | In distribution |
| 1200-5436 | Lumen/Inner Diameter 36 mm | In distribution |
| 1200-4628 | Lumen/Inner Diameter 28 mm | In distribution |
| 1260-5836 | Outer Diameter 58 mm | In distribution |
| 1200-6240 | Lumen/Inner Diameter 40 mm | In distribution |
| 1280-5836 | Lumen/Inner Diameter 36 mm | In distribution |
| 1280-5032 | Lumen/Inner Diameter 32 mm | In distribution |
| 1260-5436 | Outer Diameter 54 mm | In distribution |
| 1200-5032 | Lumen/Inner Diameter 32 mm | In distribution |
| 1200-6632 | Lumen/Inner Diameter 32 mm | In distribution |
| 1260-5032 | Outer Diameter 50 mm | In distribution |
| 1260-5232 | Lumen/Inner Diameter 32 mm | In distribution |
| 1215-6632 | Lumen/Inner Diameter 32 mm | In distribution |
| 1280-5232 | Lumen/Inner Diameter 32 mm | In distribution |
| 1200-6228 | Lumen/Inner Diameter 28 mm | In distribution |
| 1215-6240 | Lumen/Inner Diameter 40 mm | In distribution |
| 1200-5232 | Lumen/Inner Diameter 32 mm | In distribution |
| 1200-5428 | Lumen/Inner Diameter 28 mm | In distribution |
| 1215-5032 | Lumen/Inner Diameter 32 mm | In distribution |
| 1260-6236 | Outer Diameter 62 mm | In distribution |
| 1260-4628 | Lumen/Inner Diameter 28 mm | In distribution |
| 1280-6636 | Lumen/Inner Diameter 36 mm | In distribution |
| 1280-4628 | Outer Diameter 46 mm | In distribution |
| 1260-6636 | Outer Diameter 66 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CS2 Acet. Cup Sys. – VitalitE | Shalby Advanced Technologies, Inc. | 169 |
| iTotal® Hip Replacement System | ConforMIS, Inc. | 131 |
| CS2 Acet. Cup Sys. – VitalitE | Consensus Orthopedics, Inc. | 124 |
| DJO Surgical | Encore Medical, L.P. | 99 |
| MobileLink Acetabular Cup System | Waldemar Link GmbH & Co. KG | 68 |
| G7 | Biomet Orthopedics | 54 |
| Vitelene® | Aesculap AG | 52 |
| Conformis Hip System | ConforMIS, Inc. | 51 |
| Onvoy | Globus Medical, Inc. | 48 |
| Ringloc HIP System | Biomet Orthopedics | 35 |
| Prime | Microport Orthopedics Inc. | 32 |
| NovoHip Total Hip System | Novosource, LLC | 28 |
Showing 12 of 100. All products under Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K140701 | 2014-06-27 |
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.