# K182039: Arthrex Univers Revers Porous Coated Baseplate and Universal Glenoid Inlay

- Pathway: 510(k) (Traditional)
- Applicant: Arthrex, Inc.
- Decided: Sep 28, 2018 after 60 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: 14 generations back to K911686 (1991). 45 ancestors in all.
No later device cites it as a predicate yet.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172371: Arthrex UNIVERS REVERS COATED BASEPLATE, Arthrex, Inc. (2018) Summary page 4.

## Indications for use
The Arthrex UNIVERS REVERS POROUS COATED BASEPLATE is designed to be used as the glenoid component of the existing Univers Revers Shoulder Prosthesis System or Univers II Shoulder Arthroplasty System. The Arthrex UNIVERS REVERS POROUS COATED BASEPLATE 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 Arthrex UNIVERS REVERS POROUS COATED BASEPLATE is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. The Arthrex UNIVERS REVERS POROUS COATED BASEPLATE is porous coated and is intended for cementless use with the addition of screws for fixation. The Arthrex UNIVERS REVERS POROUS COATED BASEPLATE AND UNIVERSAL GLENOID INLAY are indicated for use in anatomic joint replacement(s) when conditions including severe pain or significant disability resulting from degenerative, rheumatoid, traumatic disease, fracture or injury of the glenohumeral joint; non-union humeral head fractures of long duration; avascular necrosis of the humeral head; neoplastic or dysplastic diseases; or other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable. For anatomic joint replacement, the Arthrex UNIVERS REVERS POROUS COATED BASEPLATE AND UNIVERSAL GLENOID INLAY are indicated to be used with the humeral components of the Arthrex Univers II Shoulder Prosthesis System for total shoulder arthroplasty. The UNIVERSAL GLENOID INLAY is intended for use with the UNIVERS REVERS POROUS COATED BASEPLATE.

Source page: https://510kreport.com/device/K182039
Methodology: https://510kreport.com/methodology