Depuy Global Unite Shoulder System
FDA 510(k) K133834 · Depuy(Ireland)
510(k) numberK133834
Submission
- Device name
- Depuy Global Unite Shoulder System
- Applicant
- Depuy(Ireland)
Co. Cork, IE - Received
- December 17, 2013
- Decision date
- April 3, 2014
- 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 |
|---|---|---|
| K212683 | GLOBAL ICON Stemless Shoulder SystemPKC · Traditional | 01/19/2022SE |
| K192855 | DELTA XTEND(TM) Reverse Shoulder SystemPHX · Traditional | 02/24/2020SE |
| K190344 | DePuy Corail AMT Hip ProsthesisLZO · Traditional | 11/01/2019SE |
| K191779 | Attune Revision LPS InsertsKRO · Traditional | 10/08/2019SE |
| K192448 | Delta Xtend Revers Shoulder SystemPHX · Special | 10/04/2019SE |
| K183077 | Delta Xtend Reverse Shoulder SystemPHX · Traditional | 05/17/2019SE |
| K170806 | ATTUNE Cemented Tibial Base, Fixed BearingJWH · Traditional | 06/15/2017SE |
| K160907 | DePuy Actis DuoFix Hip ProsthesisMEH · Traditional | 07/19/2016SE |
| K160700 | ATTUNE Revision Knee SystemJWH · Traditional | 06/10/2016SE |
| K140881 | Depuy Attune Knee System - Cementless CR and PS Femoral ComponenetsMBH · Traditional | 02/13/2015SE |
Questions and answers
When was Depuy Global Unite Shoulder System cleared by the FDA?
Depuy Global Unite Shoulder System (K133834) received a 510(k) decision of Substantially Equivalent on April 3, 2014, 107 days after the submission was received.
What is the product code of K133834?
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.