# K990137: Anatomica Humeral Stem/Head Components

- Pathway: 510(k) (Traditional)
- Applicant: Sulzer Orthopedics, Inc.
- Decided: Feb 18, 1999 after 35 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
No predicates in its family tree.
365 later devices descend from it; 4 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. The FDA summary names its predicate without a number.
- (no number) Sulzer Orthopedics Select Shoulder Titanium Humeral Prosthesis: named in the summary without a submission number
- (no number) Sulzer Orthopedics Select Shoulder CoCr Humeral Stem Prosthesis: named in the summary without a submission number
- (no number) Orthomet/3M Modular Neer II Shoulder System: named in the summary without a submission number
- (no number) Zimmer Fenlin Total Shoulder: named in the summary without a submission number
- (no number) Smith & Nephew Richards Cofield Shoulder: named in the summary without a submission number
- (no number) Kirschner/Biomet Atlas Shoulder: named in the summary without a submission number
- (no number) Kirschner/Biomet Mod II-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 Total Shoulder System: named in the summary without a submission number

## 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

## Indications for use
The Anatomica Humeral Stem/Head is intended for cemented use in treatment of the following: 1. 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/K990137
Methodology: https://510kreport.com/methodology