Klassic HD Low Profile Acetabular Insert With E-Link Poly
Klassic HD Low Profile Acetabular Insert with E-Link Poly is the polyethylene bearing component used in a hip replacement socket. It articulates with the femoral head within the compatible…
Klassic HD Low Profile Acetabular Insert with E-Link Poly is the polyethylene bearing component used in a hip replacement socket. It articulates with the femoral head within the compatible Klassic HD Hip System.
The material is ultra-high-molecular-weight polyethylene cross-linked by gamma irradiation and infused with vitamin E. The low-profile insert is a separate bearing option within the modular hip assembly.
Listed Item
Low Profile Acetabular Insert with E-Link Poly, 36mm head, size 58mm
Material Processing and Supply
Gamma irradiation produces the cross-linked material, while ethylene oxide gas is used to sterilize the finished insert. The implant is supplied for single use, with model dimensions matched to the specified hip-system components.
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 | Total Joint 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 | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K173104 |
| Record published | 2017-11-30 |
| Record revised | 2018-07-06 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: The Klassic HD Hip System should be stored in a clean, dry location at room temperature |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3509.58.036 | 36mm head, size 58mm | In distribution |
| 3509.56.036 | 36mm head, size 56mm | In distribution |
| 3509.52.036 | 36mm head, size 52mm | In distribution |
| 3509.46.028 | 28mm head, size 46mm | In distribution |
| 3509.56.032 | 32mm head, size 56mm | In distribution |
| 3509.54.032 | 32mm head, size 54mm | In distribution |
| 3509.52.032 | 32mm head, size 52mm | In distribution |
| 3509.60.032 | 32mm head, size 60mm | In distribution |
| 3509.44.028 | 28mm head, size 44mm | In distribution |
| 3509.50.032 | 32mm head, size 50mm | In distribution |
| 3509.44.022 | 22mm head, size 44mm | In distribution |
| 3509.48.032 | 32mm head, size 48mm | In distribution |
| 3509.64.032 | 32mm head, size 64mm | In distribution |
| 3509.62.036 | 36mm head, size 62mm | In distribution |
| 3509.60.036 | 36mm head, size 60mm | In distribution |
| 3509.62.032 | 32mm head, size 62mm | In distribution |
| 3509.58.032 | 32mm head, size 58mm | In distribution |
| 3509.46.022 | 22mm head, size 46mm | In distribution |
| 3509.64.036 | 36mm head, size 64mm | In distribution |
| 3509.54.036 | 36mm head, size 54mm | 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 |
|---|---|
| K173104 | 2017-10-27 |
| K141972 | 2014-10-09 |
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.