# K252404: Comprehensive Reverse Shoulder - HA Glenosphere Baseplates

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Orthopedics
- Decided: Apr 15, 2026 after 258 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: 15 generations back to K911686 (1991). 111 ancestors in all.
No later device cites it as a predicate yet.
1 of 112 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193373: Comprehensive® Reverse Shoulder, Biomet, Inc. (2020) Summary page 5.
- K214001: Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System, Biomet Manufacturing Corp (2023) Summary page 5.
- K080642: Comprehensive Reverse Shoulder, Biomet, Inc. (2008) Summary page 5.
- K120121: Comprehensive Reverse Shoulder-Mini Baseplate, Biomet, Inc. (2012) Summary page 5.
- K172502: Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate, Biomet Manufacturing Corp (2018) Summary page 5.

## Indications for use
Biomet Comprehensive Reverse Shoulder Products are 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 Biomet Comprehensive Reverse Shoulder Products is indicated for primary, fracture, or revision reverse total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. Titanium glenospheres are intended for patients with Cobalt 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 cobalt alloy glenospheres. A Cobalt Alloy glenosphere is the recommended component for reverse shoulder arthroplasty for patients without material sensitivity to cobalt alloy. Glenoid components with Hydroxyapatite (HA) coating applied over the Ti6Al4V coating are indicated only for uncemented applications. The Glenoid Baseplate components are intended for cementless application with the addition of screw fixation. Humeral stem components are indicated for either cemented or uncemented biological fixation applications.

Source page: https://510kreport.com/device/K252404
Methodology: https://510kreport.com/methodology