# K120121: Comprehensive Reverse Shoulder-Mini Baseplate

- Pathway: 510(k) (Special)
- Applicant: Biomet, Inc.
- Decided: Feb 16, 2012 after 30 days
- Product code: PHX (Shoulder Prosthesis, Reverse Configuration)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: 4 (0 Class I)
- 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.
69 later devices descend from it; 9 cite it directly.
1 of 122 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
- K152754: Comprehensive Vault Reconstruction System (VRS) (2016), 22 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

## Recalls of this device
- Sep 2, 2020 · Class II · Z-0093-2021: Product potentially being packaged without a taper adapter or baseplate. The package should contain one (1) baseplate and one (1) taper adapter, product may be packaged with two (2) baseplates and no 
- Feb 25, 2020 · Class II · Z-1615-2020: Package is intended to contain one (1) baseplate and one (1) taper adapter; however, devices may be packaged with two (2) baseplates and no (0) adapters.
- Dec 21, 2018 · Class II · Z-0972-2019: The product was potentially being packaged without a taper adapter.
- Jan 7, 2015 · Class II · Z-1208-2015: The taper adaptor is missing from the packaging, which may result in a delay in surgery greater than 30 minutes.

## 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 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 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. 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 MacroBond® 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/K120121
Methodology: https://510kreport.com/methodology