CSR Shoulder System
The CSR augmented glenoid is a polyethylene shoulder-replacement component with a 10-degree posterior wedge on its fixation surface. It articulates with a compatible humeral component in…
The CSR augmented glenoid is a polyethylene shoulder-replacement component with a 10-degree posterior wedge on its fixation surface. It articulates with a compatible humeral component in the Catalyst CSR shoulder system.
Three pegs on the back provide fixation within the glenoid bone. The bearing surface has a symmetrical oval profile, allowing the selected component to be used on either the right or left side.
Listed Item
Augmented 3-Peg Glenoid Implant – 10°, Size: Medium
Component Configuration
The augmented glenoid is made from ultra-high molecular weight polyethylene and is offered in three sizes. It is compatible with specified CSR and CSR Press-Fit humeral components. The glenoid is intended for cemented use in patients with sufficient bone stock and an intact or reconstructable rotator cuff.
Who Else Makes It
Concentrated in Jiangsu (3), Shanghai (2), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Paragon Medical Device (Changzhou) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 53 |
| 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 |
| Johnson & Johnson Medical (Depuy – Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 34 |
Record
| Listed by | Catalyst Orthoscience Inc, United States |
|---|---|
| FDA product code | KWT |
| Device type | Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented |
| Device class | Class 2 |
| Regulation | 21 CFR 888.3650 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K191811 |
| Record published | 2019-09-19 |
| Record revised | 2019-12-23 (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 |
| Storage | Special storage condition: Sterile instruments should be stored in a limited access area that is well ventilated and provides protection from dust, |
| Distribution end date | 2019-02-11 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1227-4125-003 | In distribution | |
| 1227-7003-001 | In distribution | |
| 1226-5038-002 | In distribution | |
| 1226-5038-001 | In distribution | |
| 1227-7003-002 | In distribution | |
| 1227-4126 | In distribution | |
| 1227-7003-003 | In distribution | |
| 1227-4125-001 | In distribution | |
| 1226-5038-003 | In distribution | |
| 1227-4125-002 | In distribution | |
| 1226-4117 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Equinoxe | Exactech, Inc. | 336 |
| SMR Shoulder | Limacorporate | 289 |
| Tornier Perform Humeral System | Tornier Inc. | 119 |
| Bigliani/Flatow® | Zimmer, Inc. | 119 |
| Trabecular Metal® | Zimmer, Inc. | 115 |
| Jarvis Glenoid Rerverse Shoulder Prosthesis | Fournitures Hospitalieres Industrie | 103 |
| Comprehensive® Shoulder System | Biomet Orthopedics | 86 |
| Alliance® | Zimmer, Inc. | 68 |
| Anatomical Shoulder™ | Zimmer, Inc. | 54 |
| Aetos Shoulder System | Smith & Nephew, Inc. | 53 |
| Perform™ Humeral System | Tornier Inc. | 47 |
| Bio-Modular® Shoulder System | Biomet Orthopedics | 43 |
Showing 12 of 164. All products under Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K191811 | 2019-09-11 |
| K182500 | 2019-01-11 |
| K181287 | 2018-07-12 |
| K173812 | 2018-03-09 |
| K152825 | 2016-05-11 |
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.