Total Shoulder System
FDA 510(k) K102670 · Shoulder Innovations, LLC
510(k) numberK102670
Submission
- Device name
- Total Shoulder System
- Applicant
- Shoulder Innovations, LLC
Ada, MI, US - Received
- September 16, 2010
- Decision date
- January 24, 2011
- 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 |
|---|---|---|
| K262173 | N22 Offset Humeral HeadKWT · Traditional | 09/08/2026SE |
| K254128 | InSet Reverse Total Shoulder SystemPHX · Traditional | 04/13/2026SE |
| K252516 | N22 EZ GlenospherePHX · Traditional | 01/15/2026SE |
| K252221 | Inset Reverse Total Shoulder SystemPHX · Traditional | 09/26/2025SE |
| K241817 | InSet Total Shoulder SystemKWT · Traditional | 02/11/2025SE |
| K213615 | Shoulder Innovations Total Shoulder SystemPKC · Traditional | 03/11/2022SE |
| K210533 | Inset Reverse Total Shoulder SystemPHX · Traditional | 08/20/2021SE |
| K192365 | Shoulder Innovations Total Shoulder SystemKWT · Special | 11/29/2019SE |
| K173824 | Humeral Short Stem SystemMBF · Traditional | 10/23/2018SE |
| K111596 | Total Shoulder SystemKWS · Special | 07/05/2011SE |
Questions and answers
When was Total Shoulder System cleared by the FDA?
Total Shoulder System (K102670) received a 510(k) decision of Substantially Equivalent on January 24, 2011, 130 days after the submission was received.
What is the product code of K102670?
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.