Plasma Sprayed Shoulder
FDA 510(k) K003324 · Encore Orthopedics, Inc.
510(k) numberK003324
Submission
- Device name
- Plasma Sprayed Shoulder
- Applicant
- Encore Orthopedics, Inc.
Austin, TX, US - Received
- October 24, 2000
- Decision date
- December 6, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|
| K032905 | 3DKNEE Porous Coated Femoral ComponentMBH · Traditional | 07/06/2004SE |
| K020114 | 3D KneeJWH · Traditional | 07/12/2002SE |
| K020741 | Unicondylar KneeHRY · Traditional | 06/04/2002SE |
| K020236 | Modification to Pass Spinal SystemKWP · Special | 02/14/2002SE |
| K020170 | Keystone Hip System Calcar Replacement Body and Build UpLPH · Special | 02/11/2002SE |
| K013490 | Cemented Calcar Hip SystemLPH · Traditional | 01/17/2002SE |
| K013442 | Pass Spinal SystemKWP · Traditional | 01/15/2002SE |
| K013431 | Pass Spinal SystemMNI · Special | 11/15/2001SE |
| K013191 | Pass Spinal SystemMNI · Special | 10/24/2001SE |
| K011856 | Radiographic MarkersNEU · Traditional | 08/22/2001SE |
Questions and answers
When was Plasma Sprayed Shoulder cleared by the FDA?
Plasma Sprayed Shoulder (K003324) received a 510(k) decision of Substantially Equivalent on December 6, 2001, 408 days after the submission was received.
What is the product code of K003324?
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.