# K190521: Aequalis Ascend Flex Shoulder System

- Pathway: 510(k) (Special)
- Applicant: Tornier S.A.S.
- Decided: Jun 12, 2019 after 100 days
- Product code: KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K911686 (1991). 138 ancestors in all.
12 later devices descend from it; 1 cites it directly.
1 of 151 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122698: Aequalis Ascend Flex Shoulder System, Tornier S.A.S. (2013) Summary page 5.
- K151293: Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis, Tornier S.A.S. (2015) Summary page 5.

## Most influential descendants
- K201315: PERFORM Humeral System – Stem (2020), 11 descendants of its own
- K212800: PRIMA Humeral System and SMR Glenosphere Ø42 (2022), 2 descendants of its own
- K241878: Tornier Humeral Reconstruction System (Tornier HRS); Tornier Perform Humeral System - Stem (Tornier PHS-Stem) (2024), 1 descendant of its own
- K240876: Identity Shoulder System (2024), 1 descendant of its own
- K233712: PRIMA Humeral System; PRIMA TT Glenoid (2024), 1 descendant of its own

## Indications for use
IN ANATOMIC: The stem and head may be used by themselves, as a hemiarthroplasty, if the natural glenoid provides a sufficient bearing surface, or in conjunction with the glenoid, as a total replacement. The Aequalis Ascend Flex Shoulder System is to be used only in patients with an intact or reconstructable rotator cuff, where it is intended to provide increased mobility and stability and to relieve pain. The Aequalis Ascend Flex Shoulder System is indicated for use as a replacement of shoulder joints disabled by: - Rheumatoid arthritis with pain - Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis) - Correction of functional deformity - Fractures of the humeral head - Traumatic arthritis - Revision of other devices if sufficient bone stock remains IN REVERSE: The Aequalis Ascend Flex Shoulder System is indicated for use as a replacement of shoulder joints for patients with a functional deltoid muscle and with massive and non-repairable rotator cuff-tear with pain disabled by: - Rheumatoid arthritis - Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis) - Correction of functional deformity - Fractures of the humeral head - Traumatic arthritis - Revision of the devices if sufficient bone stock remains The reversed adapter is indicated for use as components of the Aequalis Ascend Flex Shoulder System total shoulder replacement and for transformation of the Aequalis Ascend Flex Shoulder System into a reverse shoulder prosthesis without the removal of the humeral stem during revision surgery for patients with a functional deltoid muscle. The components are permitted to be used in the transformation from anatomic to reverse if the humeral stem is well fixed, the patient has a functional deltoid muscle; the arthropathy is associated with a massive and non-repairable rotator cuff-tear.

Source page: https://510kreport.com/device/K190521
Methodology: https://510kreport.com/methodology