# K043346: Genesis Total Shoulder Replacement, Model 100-01-00

- Pathway: 510(k) (Traditional)
- Applicant: Genesis Medical LLC
- Decided: Jan 31, 2005 after 56 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Zimmer Select: named in the summary without a submission number
- (no number) Biomet Bio-Modular total shoulder: named in the summary without a submission number
- (no number) Tornier Aequalis: named in the summary without a submission number
- (no number) Global Total Shoulder: named in the summary without a submission number
- (no number) Solar shoulder system: named in the summary without a submission number

## Most influential descendants
- K120374: Seviin Reverse Shoulder (2012), 1 descendant of its own
- K131277: Seviin Fracture Shoulder (2013), 0 descendants of its own

## Indications for use
Total shoulder or hemi-shoulder replacement is indicated for: 1. A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis. 2. 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. 3. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g., revision of a failed primary component). Hlemi-shoulder replacement is also indicated for: 1. Ununited humeral head fractures. 2. Avascular necrosis of the humeral head.

Source page: https://510kreport.com/device/K043346
Methodology: https://510kreport.com/methodology