Arrow Anatomical Shoulder System
FDA 510(k) K093599 · Fournitures Hospitalieres Industrie
510(k) numberK093599
Submission
- Device name
- Arrow Anatomical Shoulder System
- Applicant
- Fournitures Hospitalieres Industrie
Quimper Finistere, FR - Received
- November 20, 2009
- Decision date
- November 24, 2010
- 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 |
|---|---|---|
| K171789 | ARROW Reverse Porous GlenoidPHX · Traditional | 01/23/2018SE |
| K163148 | BePOD® Foot ScrewsHWC · Traditional | 09/14/2017SE |
| K163710 | BePOD® EZ Weil ScrewsHWC · Traditional | 09/08/2017SE |
| K162068 | ARROW Anatomical Porous glenoidMBF · Traditional | 04/10/2017SE |
| K170040 | BePOD Cannulated Arthrodesis ScrewsHWC · Traditional | 04/04/2017SE |
| K150568 | ARROW Humeral stems size 6 and 16PHX · Traditional | 10/29/2015SE |
| K150471 | CalcaNail Orthopedic Arthrodesis NailHSB · Traditional | 05/22/2015SE |
| K150463 | CalcaNail Orthopedic NailHSB · Traditional | 05/22/2015SE |
| K142778 | ARROW Reverse Shoulder long keel and short keel glenoid basePHX · Traditional | 03/20/2015SE |
| K120740 | Cols® Fixation SystemMBI · Special | 03/05/2013SE |
Questions and answers
When was Arrow Anatomical Shoulder System cleared by the FDA?
Arrow Anatomical Shoulder System (K093599) received a 510(k) decision of Substantially Equivalent on November 24, 2010, 369 days after the submission was received.
What is the product code of K093599?
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.