# K230366: Arthrex Univers Revers Monoblock Stem Size 4/33

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Apr 10, 2023 after 59 days
- Product code: PHX (Shoulder Prosthesis, Reverse Configuration)
- 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: 15 generations back to K911686 (1991). 77 ancestors in all.
No later device cites it as a predicate yet.
0 of 78 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130129: Univers Revers Shoulder Prosthesis System, Arthrex, Inc. (2013) Summary page 4.
- K170414: Arthrex Univers Revers Apex Humeral Stems, Arthrex, Inc. (2017) Summary page 4.
- K171841: Arthrex Shoulder System, Arthrex, Inc. (2018) Summary page 4.
- K181555: Arthrex Fracture Adapter Hemi Shoulder Prosthesis, Arthrex, Inc. (2018) Summary page 4.
- K221232: Univers Revers Humeral Cup Implant, Arthrex, Inc. (2022) Summary page 4.

## Indications for use
The Univers Revers Shoulder Prosthesis System is indicated for use in a grossly rotator cuff deficient glenohumeral joint with severe arthropathy or a previously failed joint replacement with a gross rotator cuff deficiency. The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. The Univers Revers Shoulder Prosthesis System is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to rotator cuff deficiency. (Humeral) Stems are intended for cemented or cementless applications for use with Arthrex Humeral SutureCups. The glenoid baseplate is CaP coated and is intended for cementless use with the addition of screws for fixation.

Source page: https://510kreport.com/device/K230366
Methodology: https://510kreport.com/methodology