# K122698: Aequalis Ascend Flex Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Tornier S.A.S.
- Decided: Jan 8, 2013 after 126 days
- Product code: KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K911686 (1991). 99 ancestors in all.
96 later devices descend from it; 16 cite it directly.
1 of 196 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K121493: Ascend Shoulder System, Tornier, Inc. (2012) Summary page 5.
- K112615: Aequalis Ascend Modular Reverse Shoulder System, Tornier, Inc. (2011) Summary page 5.

## Most influential descendants
- K140082: Aequalis (TM) Ascent (TM) Flex Shoulder System (2014), 29 descendants of its own
- K132285: Aequalis Reversed Shoulder Prosthesis (2013), 26 descendants of its own
- K163669: Humeris Shoulder (2017), 20 descendants of its own
- K151293: Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis (2015), 20 descendants of its own
- K141990: Encore Humeral Shoulder Stem (2014), 19 descendants of its own

## Recalls of this device
- May 28, 2021 · Class II · Z-2025-2021: Two lots have been swapped thus have the incorrect product in the package. The component may be of a different thickness.
- Oct 18, 2019 · Class II · Z-0405-2020: During shipping, it is possible for the Aequalis Ascend Flex humeral stem to become unseated or otherwise move within its internal packaging restraints. Movement within the packaging may cause the pro

## Indications for use
SYSTEM INTENDED USE: The Aequalis Ascend Flex Shoulder System is intended for use as: A replacement of shoulder joints in primary anatomic or in primary reverse. A replacement of other shoulder joints devices in case of revisions if sufficient bone stock remains. The Aequalis Ascend Flex Shoulder System also allows for conversions from anatomic to reverse shoulder prosthesis in case of revision. 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. All components are single use. The coated humeral stem is intended for cemented or cementless use. The non-coated humeral stem is intended for cemented use only. All poly glenoid components are intended for cemented use only. The glenoid sphere implant is anchored to the bone with screws and is for non-cemented fixation.

Source page: https://510kreport.com/device/K122698
Methodology: https://510kreport.com/methodology