# K110905: Total Shoulder System

- Pathway: 510(k) (Special)
- Applicant: Shoulder Innovations, LLC
- Decided: May 24, 2011 after 54 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: 4 generations back to K943462 (1994). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102670: Total Shoulder System, Shoulder Innovations, LLC (2011) Summary page 1.
- K052472: Depuy Global Shoulder Crosslink Glenoid, DePuy Orthopaedics, Inc. (2005) Summary page 1.

## Indications for use
The Shoulder Innovations Total Shoulder System is intended for use as an orthopedic implant for partial or total shoulder arthroplasty to treat the following: 1. significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; 2. united humeral head fractures of long duration; 3. irreducible 3- and 4-part proximal humeral fractures; 4. avascular necrosis of the humeral head. The assembled humeral component may be used alone for hemniarthroplasty or combined with the glenoid component for total shoulder arthroplasty. The Total Shoulder System components are intended for single use only. The glenoid component is intended for cemented fixation only; the humneral stem may be implanted by press-fit or cement fixation.

Source page: https://510kreport.com/device/K110905
Methodology: https://510kreport.com/methodology