# K131277: Seviin Fracture Shoulder

- Pathway: 510(k) (Traditional)
- Applicant: Ingen Orthopedics, LLC
- Decided: Aug 28, 2013 after 114 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: 12 generations back to K911686 (1991). 82 ancestors in all.
No later device cites it as a predicate yet.
1 of 83 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043346: Genesis Total Shoulder Replacement, Model 100-01-00, Genesis Medical LLC (2005) Summary page 1.
- K984541: Global FX Humeral Stem, Global Advantage Humeral Head, DePuy Orthopaedics, Inc. (1999) Summary page 1.
- K092900: Exactech Equinoxe Platform Fracture Stem and Revision Platform Fracture Stem, Exactech, Inc. (2010) Summary page 1.
- K120374: Seviin Reverse Shoulder, Ingen Orthopedics, LLC (2012) Summary page 1.

## Indications for use
The SEVIIN Fracture Shoulder is intended for cemented use for a severely painful and/or disabled shoulder joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis. It is also intended for fracture dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon’s experience indicates that alternative methods of treatment are unsatisfactory. The device can be used in other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. revision of failed primary component). Hemi-shoulder replacement is also indicated for un-united humeral head fractures and avascular necrosis of the humeral head. The SEVIIN Fracture Shoulder is also indicated for fracture total shoulder arthroplasty (due to acute fracture of the proximal humerus in combination with degenerative diseases of the glenohumeral joint) 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 SEVIIN Fracture Shoulder humeral stems are intended for cemented applications. The glenoid components are intended for cemented use (total shoulder arthroplasty) and the TPS coated metaglene component is intended for cementless use with the addition of screws for fixation (reverse arthroplasty).

Source page: https://510kreport.com/device/K131277
Methodology: https://510kreport.com/methodology