AEQUALIS FLEX REVIVE Shoulder System
FDA 510(k) K191318 · Tornier, Inc.
510(k) numberK191318
Submission
- Device name
- AEQUALIS FLEX REVIVE Shoulder System
- Applicant
- Tornier, Inc.
Bloomington, MN, US - Received
- May 15, 2019
- Decision date
- June 14, 2019
- 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 |
|---|---|---|
| K260721 | Tornier Perform Advanced GlenoidKWS · Traditional | 07/22/2026SE |
| K252788 | Tornier Perform Reversed Monopost Glenoid (Perform Mono)PHX · Traditional | 01/08/2026SE |
| K251686 | Tornier Humeral Reconstruction System Max (Tornier HRS Max)KWT · Traditional | 10/30/2025SE |
| K230352 | Tornier Humeral Nail and Tornier Long Humeral NailHSB · Traditional | 10/31/2023SE |
| K220914 | Tornier Perform Humeral System FracturePHX · Traditional | 10/14/2022SE |
| K220418 | Tornier Perform Humeral System StemlessPKC · Traditional | 09/14/2022SE |
| K211359 | Tornier Perform Patient-Matched Primary Reversed Glenoid and BLUEPRINT Patient…PHX · Traditional | 11/12/2021SE |
| K213124 | Tomier Perform Reversed Glenoid Cannulated GlenospheresPHX · Special | 10/26/2021SE |
| K201315 | PERFORM Humeral System StemPAO · Traditional | 09/11/2020SE |
| K193247 | LATITUDE EV Total Elbow ArthroplastyJDB · Traditional | 08/05/2020SE |
Questions and answers
When was AEQUALIS FLEX REVIVE Shoulder System cleared by the FDA?
AEQUALIS FLEX REVIVE Shoulder System (K191318) received a 510(k) decision of Substantially Equivalent on June 14, 2019, 30 days after the submission was received.
What is the product code of K191318?
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.