# K051623: Anatomical Shoulder Keeled Glenoid

- Pathway: 510(k) (Special)
- Applicant: Zimmer GmbH
- Decided: Jul 19, 2005 after 29 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: 1 generation back to K990136 (1999). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990136: Anatomica Glenoid Component, Sulzer Orthopedics, Inc. (1999) Summary page 1.

## Most influential descendants
- K170711: ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined System (2017), 2 descendants of its own
- K193099: Anatomical Shoulder System (2020), 1 descendant of its own
- K260556: Veritas Shoulder System (2026), 0 descendants of its own

## Recalls of this device
- Sep 4, 2012 · Class II · Z-0226-2013: Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Winterthur, Switzerland, after receiving four complaints 

## Indications for use
This device is intended for cemented use in treatment of the following: * Advanced wear and tear of the shoulder joint resulting from degenerative, posttraumatic or rheumatoid arthritis. * Omarthrosis. * Rheumatoid arthritis. * Revision of shoulder prosthesis. * Traumatology: the only cone to be used in traumatological indications is the traumatology cone.

Source page: https://510kreport.com/device/K051623
Methodology: https://510kreport.com/methodology