# K230513: Arthrex Univers Apex OptiFit Humeral Stem

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Sep 26, 2023 after 214 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: 6 generations back to K800494 (1980). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131633: Arthrex Univers Apex, Arthrex, Inc. (2013) Summary page 4.

## Indications for use
The Arthrex Univers Apex OptiFit Humeral Stem is indicated in replacement when conditions include severe pain or significant disability resulting from degenerative, rheumatoid, traumatic disease, or injury of the glenohumeral joint; non-union humeral head fractures of long duration; irreducible 2- and 4- part proximal humeral fractures; avascular necrosis of the humeral head; or other difficult clinical management problems where arthrodesis or re-sectional arthroplasty is not acceptable. The glenoid components are designed for cemented fixation in the joint and must only be used with an appropriate bone cement.

Source page: https://510kreport.com/device/K230513
Methodology: https://510kreport.com/methodology