Cermet Series III
Acetabular Liner for Acetabular Shell ( 28mm Head) (UHMWPE) Neutral 58/60/62 x 48mm - 28mm Head
14manufacturers in China registered for this device type
45catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (8), Shanghai (2), Zhejiang (2). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Shanghai JPY ION-Tech Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 70 |
| Changzhou Biomet Medical Devices Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 54 |
Showing 12 of 14. All 14 manufacturers in China registered for Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
Record
| Listed by | Implants Intl. Ltd., United Kingdom |
|---|---|
| FDA product code | MEH |
| Device type | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3353 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K071583 |
| Record published | 2016-07-31 |
| Record revised | 2024-04-08 (version 4) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Special storage condition: Room temperature and Dry |
| Sizes | Outer diameter 46 to 66 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10 Deg. Hood Acetabular Liner 64/66 x 52mm – 28mm Head | Outer Diameter 66 mm | In distribution |
| 10 Deg. Hood Acetabular Liner 46/48/50 x 39mm – 28mm Head | Outer Diameter 50 mm | In distribution |
| Neutral Acetabular Liner 64/66 x 48mm – 28mm Head | Outer Diameter 66 mm | In distribution |
| Neutral Acetabular Liner 52 x 41mm – 28mm Head | Outer Diameter 52 mm | In distribution |
| Bi-Coated Acetabular Cup 48mm | Outer Diameter 48 mm | In distribution |
| Ceramic Liner 54/56 x 44mm – 32mm Head | Outer Diameter 56 mm | In distribution |
| 10 Deg. Hood Acetabular Liner 64/66 x 52mm – 36mm Head | Outer Diameter 66 mm | In distribution |
| Cermic Liner 52 x 41mm- 28mm Head | Outer Diameter 52 mm | In distribution |
| Neutral Acetabular Liner 58/60/62 x 48mm – 28mm Head | Outer Diameter 62 mm | In distribution |
| 10 Deg. Hood Acetabular Liner 64/66 x 52mm – 32mm Head | Outer Diameter 66 mm | In distribution |
| Ceramic Liner 58/60/62 x 48mm – 32mm Head | Outer Diameter 62 mm | In distribution |
| Bi-Coated Acetabular Cup 60mm | Outer Diameter 60 mm | In distribution |
| Neutral Acetabular Liner 52 x 41mm – 32mm Head | Outer Diameter 52 mm | In distribution |
| 10 Deg. Hood Acetabular Liner 52 x 41mm – 32mm Head | Outer Diameter 52 mm | In distribution |
| 10 Deg. Hood Acetabular Liner 58/60/62 x 48mm – 36mm Head | Outer Diameter 62 mm | In distribution |
| Bi-Coated Acetabular Cup 56mm | Outer Diameter 56 mm | In distribution |
| Ceramic Liner 58/60/62 x 48mm – 28mm Head | Outer Diameter 62 mm | In distribution |
| Neutral Acetabular Liner 58/60/62 x 48mm – 32mm Head | Outer Diameter 62 mm | In distribution |
| 10 Deg. Hood Acetabular Liner 58/60/62 x 48mm – 28mm Head | Outer Diameter 62 mm | In distribution |
| 10 Deg. Hood Acetabular Liner 54/56 x 39mm – 44mm Head | Outer Diameter 56 mm | In distribution |
| Neutral Acetabular Liner 54/56 x 44mm – 32mm Head | Outer Diameter 56 mm | In distribution |
| Neutral Acetabular Liner 46/48/50 x 39mm – 28mm Head | Outer Diameter 50 mm | In distribution |
| Neutral Acetabular Liner 64/66 x 52mm – 36mm Head | Outer Diameter 66 mm | In distribution |
| Bi-Coated Acetabular Cup 62mm | Outer Diameter 62 mm | In distribution |
| Cermic Liner 64/66 x 52mm – 28mm Head | Outer Diameter 66 mm | In distribution |
| Ceramic Liner 64/66 x 52mm – 32mm Head | Outer Diameter 66 mm | In distribution |
| 10 Deg. Hood Acetabular Liner 58/60/62 x 48mm – 32mm Head | Outer Diameter 62 mm | In distribution |
| Ceramic Liner 54/56 x 44mm – 36mm Head | Outer Diameter 56 mm | In distribution |
| Ceramic Liner 52 x 41mm – 32mm Head | Outer Diameter 52 mm | In distribution |
| Neutral Acetabular Liner 54/56 x44mm – 28mm Head | Outer Diameter 56 mm | In distribution |
| Ceramic Liner 46/48/50 x 39mm – 28mm Head | Outer Diameter 46 mm | In distribution |
| Bi-Coated Acetabular Cup 52mm | Outer Diameter 52 mm | In distribution |
| 10 Deg. Hood Acetabular Liner 52 x 41mm – 28mm Head | Outer Diameter 52 mm | In distribution |
| Bi-Coated Acetabular Cup 50mm | Outer Diameter 50 mm | In distribution |
| Bi-Coated Acetabular Cup 58mm | Outer Diameter 58 mm | In distribution |
| Neutral Acetabular Liner 64/66 x 52mm – 32mm Head | Outer Diameter 66 mm | In distribution |
| Bi-Coated Acetabular Cup 54mm | Outer Diameter 54 mm | In distribution |
| Ceramic Liner 58/60/62 x 48mm – 36mm Head | Outer Diameter 62 mm | In distribution |
| Bi-Coated Acetabular Cup 46mm | Outer Diameter 46 mm | In distribution |
| Ceramic Liner 54/56 x 44mm – 28mm Head | Outer Diameter 56 mm | In distribution |
| Neutral Acetabular Liner 58/60/62 x 48mm – 36mm Head | Outer Diameter 62 mm | In distribution |
| 10 Deg. Hood Acetabular Liner 54/56 x 44mm – 32mm Head | Outer Diameter 56 mm | In distribution |
| Ceramic Liner 64/66 x 52mm – 36mm Head | Outer Diameter 66 mm | In distribution |
| Bi-Coated Acetabular Cup 66mm | Outer Diameter 66 mm | In distribution |
| Bi-Coated Acetabular Cup 64mm | Outer Diameter 64 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Alteon | Exactech, Inc. | 326 |
| Novation | Exactech, Inc. | 317 |
| Pinnacle | Depuy Orthopaedics, Inc. | 305 |
| SP-CL Hip Stem | Waldemar Link GmbH & Co. KG | 219 |
| Emperion | Smith & Nephew, Inc. | 201 |
| MobileLink Acetabular Cup System | Waldemar Link GmbH & Co. KG | 154 |
| Instrument | Howmedica Osteonics Corp | 145 |
| Restoration | Howmedica Osteonics Corp | 144 |
| Mfinity Femoral System | Medacta International SA | 138 |
| Echelon | Smith & Nephew, Inc. | 134 |
| Trinity Acetabular Hip System | Corin Limited | 128 |
| Redapt | Smith & Nephew, Inc. | 127 |
Showing 12 of 805. All products under Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K071583 | 2007-07-25 |
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.