Prime
The Prime Additive Manufacturing Shell is a titanium-alloy acetabular shell and a line extension of the existing Prime Acetabular System. It is made from Ti-6Al-4V powder through additive…
The Prime Additive Manufacturing Shell is a titanium-alloy acetabular shell and a line extension of the existing Prime Acetabular System.
It is made from Ti-6Al-4V powder through additive manufacturing and is designed for cementless use at the bone-interfacing surface. The filing describes its use in total hip arthroplasty for skeletally mature patients.
Listed Item
Prime AM Quad Shell 64 MM Group F
Device Evaluation
The filing reports bench evaluations of the finished shell for deformation, frictional torque, electrochemical corrosion and shell fatigue.
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 | Microport 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 |
| Establishment | Contract manufacturer, Reprocessor, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K202705 |
| Record published | 2018-10-05 |
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, manufacturing date |
| Sizes | Outer diameter 22 to 44 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| P2LESG44 | Outer Diameter 44 mm | In distribution |
| P2LESA28 | Outer Diameter 28 mm | In distribution |
| P2LESC28 | Outer Diameter 28 mm | In distribution |
| P3SAQF64 | In distribution | |
| P2LESD36 | Outer Diameter 36 mm | In distribution |
| P2LESF36 | Outer Diameter 36 mm | In distribution |
| P2LELG32 | Outer Diameter 32 mm | In distribution |
| P2LELE32 | Outer Diameter 32 mm | In distribution |
| P2LEFF32 | Outer Diameter 32 mm | In distribution |
| P2LELF40 | Outer Diameter 40 mm | In distribution |
| P2LELC28 | Outer Diameter 28 mm | In distribution |
| P2LESD32 | Outer Diameter 32 mm | In distribution |
| P2LESF40 | Outer Diameter 40 mm | In distribution |
| P2LESD28 | Outer Diameter 28 mm | In distribution |
| P2LELG40 | Outer Diameter 40 mm | In distribution |
| P2LELC36 | Outer Diameter 36 mm | In distribution |
| P3SAQF62 | In distribution | |
| P2LEFG36 | Outer Diameter 36 mm | In distribution |
| P2LEFE40 | Outer Diameter 40 mm | In distribution |
| P2LELA22 | Outer Diameter 22 mm | In distribution |
| P2LEFE32 | Outer Diameter 32 mm | In distribution |
| P2LELA28 | Outer Diameter 28 mm | In distribution |
| P3SAQC50 | In distribution | |
| P2LESE32 | Outer Diameter 32 mm | In distribution |
| P2LELF32 | Outer Diameter 32 mm | In distribution |
| P2LESG40 | Outer Diameter 40 mm | In distribution |
| P3SAQA42 | In distribution | |
| P3SAQB46 | In distribution | |
| P2LELE36 | Outer Diameter 36 mm | In distribution |
| P2LEFC36 | Outer Diameter 36 mm | In distribution |
| P2LELG44 | Outer Diameter 44 mm | In distribution |
| P2LESC32 | Outer Diameter 32 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 |
| Novosource Total Hip System | Novosource, LLC | 33 |
| 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 |
|---|---|
| K202705 | 2021-08-20 |
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.