# K112438: Titan Modular Total Shoulder System

- Pathway: 510(k) (Special)
- Applicant: Ascension Orthopedic
- Decided: Apr 11, 2012 after 231 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 K990137 (1999). 9 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100448: Ascension Modular Total Shoulder System, Ascension Orthopedics, Inc. (2010) Summary page 1.

## Most influential descendants
- K142413: TITAN Modular Total Shoulder System (2014), 2 descendants of its own
- K254084: AETOS Shoulder System - CONCELOC Glenoids (2026), 0 descendants of its own
- K213827: TITAN Total Shoulder System (TSS), TITAN Reverse Shoulder System (RSS), TITAN Humeral Resurfacing Arthroplasty System (HRA), Modular Radial Head System (MRH), Katalyst Bipolar Radial Head System (Katalyst) (2022), 0 descendants of its own

## Indications for use
The Ascension TITAN Total Shoulder System is indicated for use as a hemi or total shoulder replacement for: Severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis. Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicated that alternative methods of treatment are unsatisfactory. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g. - revision of a failed primary component). Shoulder Hemiarthroplasty is also indicated for: Ununited humeral head fractures. Avascular necrosis of the humeral head. Rotator cuff arthropathy. Deformity and/or limited motion. The humeral component is intended for cemented or uncemented use. The glenoid component is intended for cemented use only.

Source page: https://510kreport.com/device/K112438
Methodology: https://510kreport.com/methodology