# K253592: Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Apr 13, 2026 after 147 days
- Product code: MBF (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented)
- Device class: 2
- Regulation: 21 CFR 888.3670
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 19 generations back to K911686 (1991). 173 ancestors in all.
No later device cites it as a predicate yet.
1 of 174 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240876: Identity Shoulder System, Zimmer, Inc. (2024) Summary page 5.
- K193373: Comprehensive® Reverse Shoulder, Biomet, Inc. (2020) Summary page 5.
- K181611: Comprehensive Reverse Shoulder System, Biomet Manufacturing Corp (2018) Summary page 5.
- K121543: Zimmer Trabecular Metal Reverse Shoulder System, Base Plates & Humeral Stems, Zimmer, Inc. (2012) Summary page 5.
- K233481: AltiVate Reverse® Glenoid, Encore Medical L.P. (2024) Summary page 5.
- K200209: Persona Personalized Knee System, Zimmer, Inc. (2020) Summary page 5.

## Indications for use
Zimmer Biomet 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 Zimmer Biomet 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. The titanium Glenosphere components are indicated for patients with suspected cobalt alloy sensitivity. The wear properties of Titanium and Titanium alloys are inferior to that of cobalt alloy. A Titanium Glenospheres is not recommended for patients who lack suspected material sensitivity to cobalt alloy. The humeral components are indicated for either cemented or uncemented (biological fixation). Compatible Glenoid Baseplate components are intended for cementless applications with the addition of screw fixation.

Source page: https://510kreport.com/device/K253592
Methodology: https://510kreport.com/methodology