# K230572: AETOS Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Jun 7, 2023 after 98 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: 18 generations back to K911686 (1991). 191 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 193 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220847: AETOS Shoulder System, Smith & Nephew, Inc. (2023) Summary page 5.
- K201315: PERFORM Humeral System – Stem, Tornier, Inc. (2020) Summary page 5.
- K200171: SMR TT Augmented Glenoid System, Lima Corporate S.P.A. (2020) Summary page 5.

## Most influential descendants
- K252416: AETOS Shoulder System Meta Humeral Prosthesis Size 0 (2025), 0 descendants 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 AETOS 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 AETOS Shoulder System is indicated for use as a replacement of shoulder joints disabled by: • Rheumatoid arthritis • Non-inflammatory degenerative joint disease • Correction of functional deformity • Fractures of the humeral head • Traumatic arthritis • Revision of other devices if sufficient bone stock remains The coated humeral component is intended for uncemented use. The glenoid component is intended for cemented use only. In Reverse: The AETOS 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 • Correction of functional deformity • Fractures of the humeral head • Traumatic arthritis • Revision of devices if sufficient bone stock remains The humeral liner component is indicated for use in the AETOS Shoulder System as a primary reverse total shoulder replacement and for use when converting an anatomic AETOS Shoulder System into a reverse shoulder construct. This facilitates the conversion without the removal of the humeral stem during revision surgery for patients with a functional deltoid muscle. The component is permitted to be used in the conversion from anatomic to reverse if the humeral stem is well fixed, the patient has a functional deltoid muscle; the arthroplasty is associated with a massive and non-repairable rotator cuff tear. The coated humeral stem is indicated for uncemented use. The coated glenoid baseplate is intended for cementless application with the addition of screws for fixation. Note: All implant components are single use.

Source page: https://510kreport.com/device/K230572
Methodology: https://510kreport.com/methodology