# K093803: Bio-Modular Reverse Sholder

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing Corp
- Decided: Oct 19, 2010 after 312 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: 11 generations back to K911686 (1991). 52 ancestors in all.
61 later devices descend from it; 1 cites it directly.
1 of 114 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080642: Comprehensive Reverse Shoulder, Biomet, Inc. (2008) Summary page 4.

## Most influential descendants
- K131353: Comprehensive Reverse Shoulder - Titanium Glenosphere (2013), 60 descendants of its own
- 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

## Indications for use
The Bio-Modular® 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 replacement 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 Bio-Modular® 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.

Source page: https://510kreport.com/device/K093803
Methodology: https://510kreport.com/methodology