Klassic HD Hooded Acetabular Insert With E-Link Poly
The Klassic HD Hooded Acetabular Insert with E-Link Poly is an implanted bearing for total hip replacement. It fits the Klassic HD hip system and provides the acetabular surface against…
The Klassic HD Hooded Acetabular Insert with E-Link Poly is an implanted bearing for total hip replacement. It fits the Klassic HD hip system and provides the acetabular surface against which the replacement femoral head articulates.
The insert is made from ultra-high molecular weight polyethylene that has been crosslinked using gamma irradiation and infused with vitamin E. The hooded insert is a distinct option alongside the low profile insert in the same system.
Listed Item
Hooded Acetabular Insert with E-Link Poly, 36mm head, size 60mm
Supply and Use
These inserts are supplied sterilized with ethylene oxide and are intended for single use. Component selection must match the compatible Klassic HD hip system configuration.
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 |
|---|---|---|
| 3507.60.036 | 36mm head, size 60mm | In distribution |
| 3507.44.028 | 28mm head, size 44mm | In distribution |
| 3507.44.022 | 22mm head, size 44mm | In distribution |
| 3507.56.032 | 32mm head, size 56mm | In distribution |
| 3507.48.032 | 32mm head, size 48mm | In distribution |
| 3507.62.036 | 36mm head, size 62mm | In distribution |
| 3507.58.036 | 36mm head, size 58mm | In distribution |
| 3507.60.032 | 32mm head, size 60mm | In distribution |
| 3507.58.032 | 32mm head, size 58mm | In distribution |
| 3507.64.032 | 32mm head, size 64mm | In distribution |
| 3507.54.036 | 36mm head, size 54mm | In distribution |
| 3507.52.036 | 36mm head, size 52mm | In distribution |
| 3507.46.022 | 22mm head, size 46mm | In distribution |
| 3507.52.032 | 32mm head, size 52mm | In distribution |
| 3507.56.036 | 36mm head, size 56mm | In distribution |
| 3507.54.032 | 32mm head, size 54mm | In distribution |
| 3507.46.028 | 28mm head, size 46mm | In distribution |
| 3507.62.032 | 32mm head, size 62mm | In distribution |
| 3507.64.036 | 36mm head, size 64mm | In distribution |
| 3507.50.032 | 32mm head, size 50mm | 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.