# K053274: Anatomical Shoulder Inverse/Reverse

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer GmbH
- Decided: Jan 25, 2006 after 63 days
- Product code: PHX (Shoulder Prosthesis, Reverse Configuration)
- 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: 6 generations back to K911686 (1991). 18 ancestors in all.
239 later devices descend from it; 13 cite it directly.
1 of 258 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041873: Aequalis Reversed Shoulder Prosthesis, Tornier (2004) Summary page 1.
- K021478: Delta Shoulder, Depuy, Inc. (2003) Summary page 1.
- K041066: Encore Reverse Shoulder Prosthesis, Encore Medical L.P. (2005) Summary page 1.
- K030259: Amatomical Shoulder with Removable Head, Centerplus Orthopedics, Inc. (2003) Summary page 1.

## Most influential descendants
- 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
- K080642: Comprehensive Reverse Shoulder (2008), 172 descendants of its own
- K082120: Aequalis Reversed Fracture Shoulder Prothesis (2008), 164 descendants of its own

## Recalls of this device
- Sep 4, 2012 · Class II · Z-0231-2013: 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-0229-2013: 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-0230-2013: Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur, Switzerland, after receiving four complaints 

## Indications for use
The Anatomical Shoulder Inverse /Reverse system is indicated for primary, fracture or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device. The Anatomical Shoulder primary humeral stem is intended for cemented or cementless use. The Anatomical Shoulder revision humeral stem is intended for cemented use only. The Anatomical Shoulder Inverse /Reverse glenoid fixation is intended for cementless, press-fit use. It requires screws for initial fixation.

Source page: https://510kreport.com/device/K053274
Methodology: https://510kreport.com/methodology