CS2 Acet. Cup Sys. – VitalitE
Acet. Insert, Lat. +5mm, 20° Hood, VitalitE
8manufacturers in China registered for this device type
124catalogue 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 | Consensus Orthopedics, Inc., 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 |
| Record published | 2015-09-24 |
| Record revised | 2021-07-29 (version 3) |
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 |
| Sizes | Outer diameter 22 to 36 mm |
| Distribution end date | 2021-07-28 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1166-0-3256 | Outer Diameter 32 mm | Withdrawn |
| 1166-0-3248 | Outer Diameter 32 mm | Withdrawn |
| 1177-0-2846 | Outer Diameter 28 mm | Withdrawn |
| 1107-0-3264 | Outer Diameter 32 mm | Withdrawn |
| 1166-0-2860 | Outer Diameter 28 mm | Withdrawn |
| 1106-0-2854 | Outer Diameter 28 mm | Withdrawn |
| 1188-0-3660 | Outer Diameter 36 mm | Withdrawn |
| 1106-0-3258 | Outer Diameter 32 mm | Withdrawn |
| 1177-0-3258 | Outer Diameter 32 mm | Withdrawn |
| 1177-0-2860 | Outer Diameter 28 mm | Withdrawn |
| 1177-0-3658 | Outer Diameter 36 mm | Withdrawn |
| 1188-0-3668 | Outer Diameter 36 mm | Withdrawn |
| 1106-0-2866 | Outer Diameter 28 mm | Withdrawn |
| 1107-0-2858 | Outer Diameter 28 mm | Withdrawn |
| 1166-0-3254 | Outer Diameter 32 mm | Withdrawn |
| 1188-0-3658 | Outer Diameter 36 mm | Withdrawn |
| 1106-0-3252 | Outer Diameter 32 mm | Withdrawn |
| 1107-0-3266 | Outer Diameter 32 mm | Withdrawn |
| 1107-0-3252 | Outer Diameter 32 mm | Withdrawn |
| 1177-0-3264 | Outer Diameter 32 mm | Withdrawn |
| 1177-0-2858 | Outer Diameter 28 mm | Withdrawn |
| 1166-0-3268 | Outer Diameter 32 mm | Withdrawn |
| 1188-0-3666 | Outer Diameter 36 mm | Withdrawn |
| 1106-0-2848 | Outer Diameter 28 mm | Withdrawn |
| 1166-0-3258 | Outer Diameter 32 mm | Withdrawn |
| 1166-0-3262 | Outer Diameter 32 mm | Withdrawn |
| 1106-0-3264 | Outer Diameter 32 mm | Withdrawn |
| 1188-0-3656 | Outer Diameter 36 mm | Withdrawn |
| 1177-0-3248 | Outer Diameter 32 mm | Withdrawn |
| 1177-0-3664 | Outer Diameter 36 mm | Withdrawn |
| 1177-0-3654 | Outer Diameter 36 mm | Withdrawn |
| 1107-0-3258 | Outer Diameter 32 mm | Withdrawn |
| 1106-0-2858 | Outer Diameter 28 mm | Withdrawn |
| 1166-0-2854 | Outer Diameter 28 mm | Withdrawn |
| 1106-0-2244 | Outer Diameter 22 mm | Withdrawn |
| 1177-0-2852 | Outer Diameter 28 mm | Withdrawn |
| 1166-0-2868 | Outer Diameter 28 mm | Withdrawn |
| 1107-0-2852 | Outer Diameter 28 mm | Withdrawn |
| 1177-0-2864 | Outer Diameter 28 mm | Withdrawn |
| 1166-0-3252 | Outer Diameter 32 mm | Withdrawn |
| 1166-0-2852 | Outer Diameter 28 mm | Withdrawn |
| 1106-0-3266 | Outer Diameter 32 mm | Withdrawn |
| 1107-0-2866 | Outer Diameter 28 mm | Withdrawn |
| 1107-0-3662 | Outer Diameter 36 mm | Withdrawn |
| 1177-0-3652 | Outer Diameter 36 mm | Withdrawn |
| 1106-0-3256 | Outer Diameter 32 mm | Withdrawn |
| 1106-0-3254 | Outer Diameter 32 mm | Withdrawn |
| 1166-0-2862 | Outer Diameter 28 mm | Withdrawn |
| 1107-0-3260 | Outer Diameter 32 mm | Withdrawn |
| 1108-0-3662 | Outer Diameter 36 mm | Withdrawn |
| 1107-0-3254 | Outer Diameter 32 mm | Withdrawn |
| 1188-0-3664 | Outer Diameter 36 mm | Withdrawn |
| 1108-0-3668 | Outer Diameter 36 mm | Withdrawn |
| 1177-0-2862 | Outer Diameter 28 mm | Withdrawn |
| 1166-0-2864 | Outer Diameter 28 mm | Withdrawn |
| 1106-0-2852 | Outer Diameter 28 mm | Withdrawn |
| 1177-0-3256 | Outer Diameter 32 mm | Withdrawn |
| 1177-0-2848 | Outer Diameter 28 mm | Withdrawn |
| 1107-0-2244 | Outer Diameter 22 mm | Withdrawn |
| 1177-0-3268 | Outer Diameter 32 mm | Withdrawn |
| 1107-0-3262 | Outer Diameter 32 mm | Withdrawn |
| 1107-0-2850 | Outer Diameter 28 mm | Withdrawn |
| 1166-0-3260 | Outer Diameter 32 mm | Withdrawn |
| 1177-0-3252 | Outer Diameter 32 mm | Withdrawn |
| 1177-0-2866 | Outer Diameter 28 mm | Withdrawn |
| 1107-0-3658 | Outer Diameter 36 mm | Withdrawn |
| 1106-0-3262 | Outer Diameter 32 mm | Withdrawn |
| 1166-0-2858 | Outer Diameter 28 mm | Withdrawn |
| 1106-0-2846 | Outer Diameter 28 mm | Withdrawn |
| 1106-0-2864 | Outer Diameter 28 mm | Withdrawn |
| 1107-0-3268 | Outer Diameter 32 mm | Withdrawn |
| 1177-0-3666 | Outer Diameter 36 mm | Withdrawn |
| 1107-0-2868 | Outer Diameter 28 mm | Withdrawn |
| 1107-0-3660 | Outer Diameter 36 mm | Withdrawn |
| 1108-0-3660 | Outer Diameter 36 mm | Withdrawn |
| 1107-0-2854 | Outer Diameter 28 mm | Withdrawn |
| 1106-0-3268 | Outer Diameter 32 mm | Withdrawn |
| 1177-0-3656 | Outer Diameter 36 mm | Withdrawn |
| 1177-0-3668 | Outer Diameter 36 mm | Withdrawn |
| 1107-0-2864 | Outer Diameter 28 mm | Withdrawn |
| 1108-0-3656 | Outer Diameter 36 mm | Withdrawn |
| 1166-0-3250 | Outer Diameter 32 mm | Withdrawn |
| 1188-0-3652 | Outer Diameter 36 mm | Withdrawn |
| 1107-0-3664 | Outer Diameter 36 mm | Withdrawn |
| 1166-0-2848 | Outer Diameter 28 mm | Withdrawn |
| 1177-0-3662 | Outer Diameter 36 mm | Withdrawn |
| 1166-0-2850 | Outer Diameter 28 mm | Withdrawn |
| 1107-0-2242 | Outer Diameter 22 mm | Withdrawn |
| 1188-0-3662 | Outer Diameter 36 mm | Withdrawn |
| 1108-0-3658 | Outer Diameter 36 mm | Withdrawn |
| 1107-0-3666 | Outer Diameter 36 mm | Withdrawn |
| 1106-0-2862 | Outer Diameter 28 mm | Withdrawn |
| 1177-0-2856 | Outer Diameter 28 mm | Withdrawn |
| 1108-0-3666 | Outer Diameter 36 mm | Withdrawn |
| 1106-0-3260 | Outer Diameter 32 mm | Withdrawn |
| 1177-0-3266 | Outer Diameter 32 mm | Withdrawn |
| 1106-0-2868 | Outer Diameter 28 mm | Withdrawn |
| 1166-0-2866 | Outer Diameter 28 mm | Withdrawn |
| 1166-0-2846 | Outer Diameter 28 mm | Withdrawn |
| 1166-0-3266 | Outer Diameter 32 mm | Withdrawn |
| 1177-0-2850 | Outer Diameter 28 mm | Withdrawn |
| 1106-0-2850 | Outer Diameter 28 mm | Withdrawn |
| 1106-0-2860 | Outer Diameter 28 mm | Withdrawn |
| 1107-0-2846 | Outer Diameter 28 mm | Withdrawn |
| 1107-0-2862 | Outer Diameter 28 mm | Withdrawn |
| 1107-0-3656 | Outer Diameter 36 mm | Withdrawn |
| 1177-0-3260 | Outer Diameter 32 mm | Withdrawn |
| 1107-0-2856 | Outer Diameter 28 mm | Withdrawn |
| 1188-0-3654 | Outer Diameter 36 mm | Withdrawn |
| 1107-0-3256 | Outer Diameter 32 mm | Withdrawn |
| 1166-0-2856 | Outer Diameter 28 mm | Withdrawn |
| 1166-0-3264 | Outer Diameter 32 mm | Withdrawn |
| 1107-0-2848 | Outer Diameter 28 mm | Withdrawn |
| 1107-0-2860 | Outer Diameter 28 mm | Withdrawn |
| 1177-0-2854 | Outer Diameter 28 mm | Withdrawn |
| 1177-0-3660 | Outer Diameter 36 mm | Withdrawn |
| 1177-0-3254 | Outer Diameter 32 mm | Withdrawn |
| 1106-0-2242 | Outer Diameter 22 mm | Withdrawn |
| 1177-0-3250 | Outer Diameter 32 mm | Withdrawn |
| 1177-0-3262 | Outer Diameter 32 mm | Withdrawn |
| 1177-0-2868 | Outer Diameter 28 mm | Withdrawn |
| 1108-0-3664 | Outer Diameter 36 mm | Withdrawn |
| 1106-0-2856 | Outer Diameter 28 mm | Withdrawn |
| 1107-0-3668 | Outer Diameter 36 mm | Withdrawn |
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 |
| 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 |
| Novosource Total Hip System | Novosource, LLC | 33 |
| 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 |
|---|---|
| K130652 | 2013-12-17 |
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.