# K103404: ANA0TOMICAL Shoulder TM Combined System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer GmbH
- Decided: Mar 15, 2011 after 116 days
- Product code: KWT (Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3650
- 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: 8 generations back to K911686 (1991). 41 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030259: Amatomical Shoulder with Removable Head, Centerplus Orthopedics, Inc. (2003) Summary page 1.
- K062029: Anatomical Shoulder Fracture System, Zimmer GmbH (2006) Summary page 1.
- K982981: New Zimmer Shoulder System, Zimmer, Inc. (1998)
- K022377: The Trabecular Metal Glenoid-Bigliani/Flatow the Complete Shoulder Solution, Model 4306, Implex Corp. (2002) 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
- May 12, 2012 · Class II · Z-1895-2012: Bigliani/Flatow The Complete Shoulder Solution Trabecular Metal Glenoid Instrument Drill with Stop, 6 mm. Catalog number 47-4301-031-00 was actually packaged and labeled as catalog number 47-4307-031-

## Indications for use
Advanced destruction of the shoulder joint resulting from: * Omarthrosis. * Rheumatoid arthritis * Post-traumatic arthritis * Avascular necrosis of the humeral head * Cuff-tear arthropathy (BF heads with heights of 27mm or greater) * Conditions following earlier operations (including revision shoulder arthroplasty). The Anatomical Shoulder Combined System is intended for cemented or cementless use. When used with the following humeral stems the Anatomical Shoulder Combined System is intended for cemented use: * Anatomical Shoulder Standard Cemented Humeral Stem. * Anatomical Shoulder Revision Stem. When used with the following humeral stem the Anatomical Shoulder Combined System is intended for cementless use: * Anatomical Shoulder Standard Uncemented Stem. When used with the following humeral stems the Anatomical Shoulder Combined System is intended for cemented or cementless use: * Anatomical Shoulder Fracture Stem. * Anatomical Shoulder Fracture Long Stem. When used with the following glenoids the Anatomical Shoulder Combined System is intended for cemented use: * Bigliani/Flatow Glenoid (pegged and keeled). * Trabecular Metal Glenoid.

Source page: https://510kreport.com/device/K103404
Methodology: https://510kreport.com/methodology