Equinoxe Extra Short Humeral Head
FDA 510(k) K140063 · Exactech, Inc.
510(k) numberK140063
Submission
- Device name
- Equinoxe Extra Short Humeral Head
- Applicant
- Exactech, Inc.
Gainesville, FL, US - Received
- January 10, 2014
- Decision date
- February 11, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K260583 | Equinoxe® Shoulder SystemPHX · Traditional | 04/14/2026SE |
| K250713 | Equinoxe® Humeral Reconstruction Prosthesis; Equinoxe® Stemless Shoulder ImplantsKWT · Traditional | 12/01/2025SE |
| K243448 | Equinoxe® Shoulder SystemPHX · Traditional | 08/01/2025SE |
| K243275 | Equinoxe® Scapula Fracture SystemHRS · Traditional | 06/26/2025SE |
| K243839 | Alteon® HA Femoral StemsMEH · Traditional | 03/10/2025SE |
| K240393 | Exactech® TRULIANT® Knee SystemMBH · Traditional | 10/03/2024SE |
| K233482 | Equinoxe® Central Screw Baseplate SystemPHX · Traditional | 07/18/2024SE |
| K230717 | Exactech® Vantage® Total Ankle SystemHSN · Traditional | 10/12/2023SE |
| K223933 | Exactech Equinoxe PHx Fracture System; Exactech EPIC ScrewsHRS · Traditional | 09/25/2023SE |
| K223833 | Exactech® Equinoxe® Reverse Humeral Liners and Humeral Adapter TraysPHX · Traditional | 09/14/2023SE |
Questions and answers
When was Equinoxe Extra Short Humeral Head cleared by the FDA?
Equinoxe Extra Short Humeral Head (K140063) received a 510(k) decision of Substantially Equivalent on February 11, 2014, 32 days after the submission was received.
What is the product code of K140063?
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.