# K142413: TITAN Modular Total Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Ascension Orthopedics
- Decided: Nov 14, 2014 after 78 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: 5 generations back to K990137 (1999). 10 ancestors in all.
2 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)
- K112438: Titan Modular Total Shoulder System, Ascension Orthopedic (2012) Summary page 4.

## Most influential descendants
- 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 INTEGRA TITAN™ Modular Total Shoulder System is a Total Shoulder Arthroplasty or Hemiarthroplasty which is indicated 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 factures, 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/K142413
Methodology: https://510kreport.com/methodology