# K030259: Amatomical Shoulder with Removable Head

- Pathway: 510(k) (Traditional)
- Applicant: Centerplus Orthopedics, Inc.
- Decided: Apr 24, 2003 after 90 days
- Product code: KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K990137 (1999). 3 ancestors in all.
331 later devices descend from it; 9 cite it directly.
1 of 335 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003801: Anatomical Press-Fit Humeral Stem, Sulzer Orthopedics, Inc. (2001) Summary page 2.
- K990137: Anatomica Humeral Stem/Head Components, Sulzer Orthopedics, Inc. (1999) Summary page 2.
- K003832: Sulzer Orthopedics Anatomical Shoulder Cemented Humeral Stem, Sulzer Orthopedics, Inc. (2001) Summary page 2.
- (no number) Sulzer (Centerpulse) Orthopedics Select Shoulder: named in the summary without a submission number
- (no number) Kirschner/Biomet Mod 11-C Shoulder: named in the summary without a submission number
- (no number) Biomet Bio-Modular Total Shoulder: named in the summary without a submission number
- (no number) Depuy Global Advantage Shoulder System: named in the summary without a submission number

## Most influential descendants
- K053274: Anatomical Shoulder Inverse/Reverse (2006), 239 descendants of its own
- K060874: Depuy Global AP Shoulder System (2006), 200 descendants of its own
- K063569: Equinoxe Reverse Shoulder System (2007), 190 descendants of its own
- K071948: Aequalis Reversed Adapter (2007), 178 descendants of its own
- K073688: Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw (2008), 177 descendants of its own

## Recalls of this device
- Sep 4, 2012 · Class II · Z-0223-2013: 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 
- Sep 4, 2012 · Class II · Z-0232-2013: 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 
- Sep 4, 2012 · Class II · Z-0227-2013: 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
The Centerpulse Orthopedics Anatomical ShoulderTM System with Removable Head is intended for use in treatment of the following: 1. Advanced wear of the shoulder joint resulting from degenerative, post-traumatic or rheumatic arthritis 2. Omarthrosis 3. Rheumatoid arthritis 4. Revision of shoulder prosthesis. 5. Traumatology: the only cone to be used in traumatological indications is the traumatology cone.

Source page: https://510kreport.com/device/K030259
Methodology: https://510kreport.com/methodology