Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
16 catalogue numbers from 802302203, listed by Zimmer, Inc., United States, under Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented. 8 manufacturers in China are registered for this product code.
8manufacturers in China registered for this device type
16catalogue 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 | Zimmer, 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 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K181171 |
| Record published | 2019-06-07 |
| Record revised | 2020-03-20 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 802302203 | 22.2 mm Diameter, +3 mm Neck Length | In distribution |
| 802303604 | 36 mm Diameter, +7 mm Neck Length | In distribution |
| 802204002 | 12/14 Taper, 40 mm Diameter, +0 mm, Neck Length | In distribution |
| 802304004 | 40 mm Diameter, +7 mm Neck Length | In distribution |
| 802203202 | 12/14 Taper, 32 mm Diameter, +0 mm, Neck Length | In distribution |
| 802203203 | 12/14 Taper, 32 mm Diameter, +3.5 mm, Neck Length | In distribution |
| 802302202 | 22.2 mm Diameter, +0 mm Neck Length | In distribution |
| 802202803 | 12/14 Taper, 28 mm Diameter, +3.5 mm, Neck Length | In distribution |
| 802304003 | 40 mm Diameter, +3.5 mm Neck Length | In distribution |
| 802203605 | 12/14 Taper Skirted, 36 mm Diameter, +10.5 mm, Neck Length | In distribution |
| 802302802 | 28 mm Diameter, +0 mm Neck Length | In distribution |
| 802503602 | 36 mm Diameter, -3 mm Neck Length | In distribution |
| 802303602 | 36 mm Diameter, +0 mm Neck Length | In distribution |
| 802304404 | 44 mm Diameter, +7 mm Neck Length | In distribution |
| 802203201 | 12/14 Taper, 32 mm Diameter, -3.5 mm, Neck Length | In distribution |
| 802304402 | 44 mm Diameter, +0 mm Neck Length | 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 |
| Novosource Total Hip System | Novosource, LLC | 33 |
| Prime | Microport Orthopedics Inc. | 32 |
Showing 12 of 100. All products under Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K120370 | 2012-06-04 |
Recalls Naming This Product
5 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 |
|---|---|---|---|---|---|---|
| Zimmer, Inc. | 510(k) number | 2025-03-24 | Class II | Under Investigation by firm | The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems. | 416 units |
| Zimmer, Inc. | 510(k) number | 2025-03-24 | Class II | Under Investigation by firm | The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems. | 215 units |
| Zimmer, Inc. | 510(k) number | 2025-03-24 | Class II | Under Investigation by firm | The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems. | 167 units |
| Zimmer, Inc. | 510(k) number | 2025-03-24 | Class II | Under Investigation by firm | The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems. | 158 units |
| Zimmer, Inc. | 510(k) number | 2025-03-24 | Class II | Under Investigation by firm | The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems. | 160 units |
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.