# K221232: Univers Revers Humeral Cup Implant

- Pathway: 510(k) (Special)
- Applicant: Arthrex, Inc.
- Decided: May 19, 2022 after 20 days
- Product code: HSD (Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K911686 (1991). 45 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 47 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161782: Arthrex Univers Revers Shoulder Prosthesis System, Arthrex, Inc. (2016) Summary page 4.

## Most influential descendants
- K230366: Arthrex Univers Revers Monoblock Stem Size 4/33 (2023), 0 descendants of its own

## 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 gross 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/K221232
Methodology: https://510kreport.com/methodology