Cofield Shoulder System
FDA 510(k) K843624 · Richards Medical Co., Inc.
510(k) numberK843624
Submission
- Device name
- Cofield Shoulder System
- Applicant
- Richards Medical Co., Inc.
Memphis, TN, US - Received
- September 10, 1984
- Decision date
- January 10, 1985
- Decision
- Substantially Equivalent (SESE)
- 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 |
|---|---|---|
| K896106 | Rogozinski Spinal System, Add'L ComponentsKWP · Traditional | 06/25/1990SN |
| K900628 | Modular Hip SystemLZO · Traditional | 05/09/1990SN |
| K896580 | Uni-Polar HeadLZY · Traditional | 02/15/1990SE |
| K895241 | Intramedullary Hip ScrewKTT · Traditional | 01/04/1990SE |
| K884824 | Tricon-M Total Knee SystemMBV · Traditional | 11/21/1989SN |
| K896204 | Zirconia Ceramic Head Add'L SizesLZO · Traditional | 11/20/1989SN |
| K895242 | Pappas Tri-Flange Ventilation TubeETD · Traditional | 11/17/1989SE |
| K893377 | Russell-Taylor Intramedullary Knee Fusion NailsHSB · Traditional | 11/16/1989SE |
| K885069 | Zirconia Ceramic Head (Yitria Stabilized)LZO · Traditional | 09/01/1989SN |
| K892366 | Porous Genesis Stemmed Tibial ComponentJWH · Traditional | 07/19/1989SN |
Questions and answers
When was Cofield Shoulder System cleared by the FDA?
Cofield Shoulder System (K843624) received a 510(k) decision of Substantially Equivalent on January 10, 1985, 122 days after the submission was received.
What is the product code of K843624?
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.