# K072804: Comprehensive RS Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing Corp
- Decided: Dec 12, 2007 after 72 days
- Product code: PHX (Shoulder Prosthesis, Reverse Configuration)
- 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
Longest line of descent: 7 generations back to K911686 (1991). 38 ancestors in all.
175 later devices descend from it; 3 cite it directly.
1 of 214 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021478: Delta Shoulder, Depuy, Inc. (2003) Summary page 4.
- K050315: Delta Humeral Cups, DePuy Orthopaedics, Inc. (2005)
- K030941: Aequalis Reversed Shoulder Prosthesis, Tornier (2004) Summary page 4.
- K041873: Aequalis Reversed Shoulder Prosthesis, Tornier (2004) Summary page 4.
- K041066: Encore Reverse Shoulder Prosthesis, Encore Medical L.P. (2005) Summary page 4.
- K051075: Encore Reverse Shoulder Prosthesis, Encore Medical L.P. (2005) Summary page 4.
- K052906: Zimmer Trabecular Metal Reverse Shoulder System, Zimmer, Inc. (2005) Summary page 4.
- K992119: Bio-Modular Shoulder System, Biomet, Inc. (1999) Summary page 4.
- K030710: Bio-Modular Shoulder System, Biomet, Inc. (2003) Summary page 4.
- K043100: Bio-Modular Shoulder System with Hydroxyapatite (HA) Coated Glenoid Components, Biomet, Inc. (2005) Summary page 4.

## Most influential descendants
- K080642: Comprehensive Reverse Shoulder (2008), 172 descendants of its own
- K110599: Aequalis Ascend Modular Reverse Shoulder System (2011), 108 descendants of its own
- K112615: Aequalis Ascend Modular Reverse Shoulder System (2011), 97 descendants of its own
- K122698: Aequalis Ascend Flex Shoulder System (2013), 96 descendants of its own
- K120121: Comprehensive Reverse Shoulder-Mini Baseplate (2012), 69 descendants of its own

## Indications for use
The Comprehensive® RS Shoulder System is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deitoid muscle is necessary. A cemented humeral stem must be used. The MacroBond®/HA RS Cleats are indicated only for uncemented biological fixation applications. The GT Baseplate components are intended for cementless application with the additicn of screw fixation.

Source page: https://510kreport.com/device/K072804
Methodology: https://510kreport.com/methodology