Cofied Modular Shoulder System
FDA 510(k) K955767 · Smith & Nephew Richards, Inc.
510(k) numberK955767
Submission
- Device name
- Cofied Modular Shoulder System
- Applicant
- Smith & Nephew Richards, Inc.
Memphis, TN, US - Received
- December 21, 1995
- Decision date
- April 8, 1996
- Decision
- Substantially Equivalent for Some Indications (SN)
- Type
- Traditional 510(k)
Device classification
- Product code
- KWS – Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3660
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KWS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260721 | Tornier Perform Advanced GlenoidKWS · Traditional | Tornier, Inc. | 07/22/2026SE |
| K254084 | AETOS Shoulder System - CONCELOC GlenoidsKWS · Traditional | Smith & Nephew, Inc. | 04/06/2026SE |
| K252418 | Catalyst F1x Shoulder SystemKWS · Traditional | Catalyst Orthoscience, Inc. | 11/06/2025SE |
| K252416 | AETOS Shoulder System Meta Humeral Prosthesis Size 0KWS · Traditional | Smith & Nephew, Inc. | 10/29/2025SE |
| K241292 | MyShoulder Planner (5.3SSWPL)KWS · Traditional | Medacta International S.A. | 01/30/2025SE |
| K241878 | Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System -…KWS · Traditional | Stryker Corporation (Tornier, Inc.) | 12/06/2024SE |
| K241609 | Tornier Humeral Reconstruction System (Tornier HRS)KWS · Traditional | Stryker Corporation (Tornier, Inc.) | 09/10/2024SE |
| K230513 | Arthrex Univers Apex OptiFit Humeral StemKWS · Traditional | Arthrex, Inc. | 09/26/2023SE |
| K222592 | AltiVate® Anatomic Shoulder AG e+ with MarkersKWS · Abbreviated | Encore Medical L.P. | 06/23/2023SE |
| K230572 | AETOS Shoulder SystemKWS · Traditional | Smith & Nephew, Inc. | 06/07/2023SE |
More from Smith & Nephew, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K965224 | Empower Anterior Direct ScrewsKWP · Traditional | 05/08/1997SE |
| K963509 | Global Taper Tapered Hip System, GT SpectronLPH · Traditional | 01/27/1997SE |
| K960444 | Finn Rod to Rod ConnectorKWP · Traditional | 01/24/1997SE |
| K964163 | Trimax Nail SystemHSB · Traditional | 12/27/1996SE |
| K962557 | Genesis II Zirconium Femoral Component/Profix Zirconium Femoral ComponentJWH · Traditional | 12/05/1996SN |
| K963486 | Revision Hip SystemJDI · Traditional | 11/27/1996SE |
| K962541 | Reflection Acetabular Reinforcement RingsJDJ · Traditional | 09/17/1996SE |
| K962808 | Ilizarov External Fixation SystemKTT · Traditional | 08/19/1996SE |
| K962137 | Genesis II Constrained SystemJWH · Traditional | 08/02/1996SE |
| K960094 | Reflection Dual Dimension ShellMBL · Traditional | 03/27/1996SE |
Questions and answers
When was Cofied Modular Shoulder System cleared by the FDA?
Cofied Modular Shoulder System (K955767) received a 510(k) decision of Substantially Equivalent for Some Indications on April 8, 1996, 109 days after the submission was received.
What is the product code of K955767?
The FDA product code is KWS – Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented, a Class II (moderate risk) device regulated under 21 CFR 888.3660.