# K003801: Anatomical Press-Fit Humeral Stem

- Pathway: 510(k) (Traditional)
- Applicant: Sulzer Orthopedics, Inc.
- Decided: Feb 28, 2001 after 82 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
No predicates in its family tree.
365 later devices descend from it; 3 cite it directly.
1 of 366 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K030259: Amatomical Shoulder with Removable Head (2003), 331 descendants of its own
- 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

## Recalls of this device
- Sep 4, 2012 · Class II · Z-0225-2013: 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 

Source page: https://510kreport.com/device/K003801
Methodology: https://510kreport.com/methodology