# K990136: Anatomica Glenoid Component

- Pathway: 510(k) (Traditional)
- Applicant: Sulzer Orthopedics, Inc.
- Decided: Mar 1, 1999 after 46 days
- Product code: KWS (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
135 later devices descend from it; 4 cite it directly.
0 of 136 devices in its family (counting itself) have 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 Curved Back Pegged Glenoid: 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) 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
- K032126: Promos Shoulder (2004), 130 descendants of its own
- K042021: Exactech Equinoxe Shoulder System (2004), 71 descendants of its own
- K063578: Promos Modular Shoulder System (2007), 67 descendants of its own
- K081016: Smith & Nephew, Inc., Promos Reverse Shoulder System (2008), 52 descendants of its own
- K110598: SMR Reverse Shoulder System (2011), 44 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 
- Jun 25, 2007 · Not classified · Z-1194-2007: The package actually contains a knee patellar implant.

## Indications for use
The Anatomica All-Poly Glenoid component 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/K990136
Methodology: https://510kreport.com/methodology