# K254084: AETOS Shoulder System - CONCELOC Glenoids

- Pathway: 510(k) (Traditional)
- Applicant: Smith & Nephew, Inc.
- Decided: Apr 6, 2026 after 109 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). 214 ancestors in all.
No later device cites it as a predicate yet.
1 of 215 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240716: AETOS Shoulder System Stemless Humeral Prosthesis, Smith & Nephew, Inc. (2024) Summary page 6.
- K220847: AETOS Shoulder System, Smith & Nephew, Inc. (2023) Summary page 6.
- K212356: Exactech® Equinoxe® Laser Cage Glenoid, Exactech, Inc. (2022) Summary page 6.
- K142413: TITAN Modular Total Shoulder System, Ascension Orthopedics (2014) Summary page 6.
- K211221: Porous Patella and Porous Tibia Baseplate, Smith & Nephew, Inc. (2021) Summary page 6.

## Indications for use
In Anatomic: The AETOS Shoulder System (when used with the AETOS Humeral Meta Stems) 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 humeral stems (AETOS Humeral Meta Stems) 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. When used with the AETOS Humeral Meta Stems, 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 AETOS Shoulder System (when used with AETOS Stemless Humeral Prosthesis) is to be used only in patients with an intact or reconstructable rotator cuff. When used with AETOS Stemless Humeral Prosthesis, the AETOS Shoulder System is indicated for anatomic total shoulder replacement of shoulder joints disabled by: • Non-inflammatory degenerative joint disease • Traumatic arthritis • Revision of other devices if sufficient bone stock remains The coated humeral components are intended for uncemented use. The glenoid component is intended for cemented use only. In Reverse: The AETOS Shoulder System, when used with AETOS Humeral Meta Stems, 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 stems are indicated for uncemented use. The coated glenoid base plate 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/K254084
Methodology: https://510kreport.com/methodology