# K100448: Ascension Modular Total Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Ascension Orthopedics, Inc.
- Decided: Aug 30, 2010 after 194 days
- Product code: KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K990137 (1999). 8 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032126: Promos Shoulder, Plus Orthopedics (2004) Summary page 1.
- K063578: Promos Modular Shoulder System, Plus Orthopedics AG (2007) Summary page 1.
- K962082: Osteonics All Polyethylene Glenoid Shoulder Component, Osteonics Corp. (1996) Summary page 1.

## Most influential descendants
- K112438: Titan Modular Total Shoulder System (2012), 3 descendants of its own
- K142413: TITAN Modular Total Shoulder System (2014), 2 descendants of its own
- K152047: INTEGRA TITAN Modular Total Shoulder System Fin-Lock Glenoid (2015), 1 descendant 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

## Recalls of this device
- Oct 24, 2014 · Class II · Z-0197-2015: A single lot of left and a single lot of right Reverse Shoulder System cutting templates were manufactured incorrectly. Specifically, the threaded handle has been welded backwards on the template resu

## Indications for use
The Ascension Modular Total Shoulder System is indicated for use as a hemi or total shoulder replacement for: 1. 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). Shoulder Hemiarthroplasty is also indicated for: 1. Ununited humeral head fractures. 2. Avascular necrosis of the humeral head. 3. Rotator cuff arthropathy. 4. Deformity and/or limited motion. The humeral component is intended for cemented or un-cemented use. The glenoid component is intended for cemented use only.

Source page: https://510kreport.com/device/K100448
Methodology: https://510kreport.com/methodology