# K131353: Comprehensive Reverse Shoulder - Titanium Glenosphere

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing Corp
- Decided: Oct 8, 2013 after 151 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: 12 generations back to K911686 (1991). 73 ancestors in all.
60 later devices descend from it; 5 cite it directly.
1 of 134 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080842: Apex Knee System, Model KC-230XY, KC-240XY [ NO Holes, 2 Holes], Omni Life Science, Inc. (2008) Summary page 4.
- K120121: Comprehensive Reverse Shoulder-Mini Baseplate, Biomet, Inc. (2012) Summary page 4.
- K030710: Bio-Modular Shoulder System, Biomet, Inc. (2003) Summary page 4.
- K093803: Bio-Modular Reverse Sholder, Biomet Manufacturing Corp (2010) Summary page 4.

## Most influential descendants
- K140478: Aequalis Reversed Shoulder Prosthesis (2014), 21 descendants of its own
- K193373: Comprehensive® Reverse Shoulder (2020), 20 descendants of its own
- K172502: Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate (2018), 20 descendants of its own
- K151293: Aequalis Ascend Flex Shoulder System, Aequalis Reversed Shoulder Prosthesis (2015), 20 descendants of its own
- K191746: SMR TT Augmented Glenoid System (2019), 12 descendants of its own

## Indications for use
The Comprehensive® Reverse Shoulder is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacemsnt with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The Comprehensive® Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. Titanium glenospheres are intended for patients with colbalt alloy material sensitivity. The wear of these devices has not been tested but, based on pin on disk testing, the wear rate is inferior to that of cobait alloy glenospheres. A cobalt alloy glenosphere is the recommended component for reverse shoulder arthroplasty patuents without material sensitivity to cobalt alloy. Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. The Glenoid Baseplate components are intended for cementless application with the addition of screw fixation. Interlok® finish humeral stems are intended for cemented use and the Macro Bond® coated humeral stems are intended for press-fit or cemented applications. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.

Source page: https://510kreport.com/device/K131353
Methodology: https://510kreport.com/methodology