# K120374: Seviin Reverse Shoulder

- Pathway: 510(k) (Traditional)
- Applicant: Ingen Orthopedics, LLC
- Decided: Jul 9, 2012 after 154 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: 7 generations back to K911686 (1991). 20 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053274: Anatomical Shoulder Inverse/Reverse, Zimmer GmbH (2006) Summary page 4.
- K041873: Aequalis Reversed Shoulder Prosthesis, Tornier (2004) Summary page 4.
- K041066: Encore Reverse Shoulder Prosthesis, Encore Medical L.P. (2005) Summary page 4.
- K043346: Genesis Total Shoulder Replacement, Model 100-01-00, Genesis Medical LLC (2005) Summary page 4.

## Most influential descendants
- K131277: Seviin Fracture Shoulder (2013), 0 descendants of its own

## Indications for use
The SEVIIN Reverse Shoulder is indicated for primary, fracture or revision total shoulder arthroplasty for the relief of pain and to improve function in patients with a massive and non-repairable rotator cuff tear. The patient’s joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device. The humeral component is intended for cemented use and the TPS ‘coated metaglene component is intended for cementless use with the addition of screws for fixation.

Source page: https://510kreport.com/device/K120374
Methodology: https://510kreport.com/methodology