# K132239: Comprehensive Reverse Shoulder Screws

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing Corp
- Decided: Sep 6, 2013 after 50 days
- Product code: PHX (Shoulder Prosthesis, Reverse Configuration)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: 2 (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.
25 later devices descend from it; 2 cite it directly.
1 of 78 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
- K193373: Comprehensive® Reverse Shoulder (2020), 20 descendants of its own
- K212737: INHANCE™ Reverse Shoulder System (2022), 9 descendants of its own
- K200368: LINK Embrace Shoulder System - Reverse Configuration (2021), 3 descendants of its own
- K233148: Augment Off-Axis Instrument System (2024), 2 descendants of its own
- K250644: MSS - Monobloc stem (2026), 1 descendant of its own

## Recalls of this device
- Jan 15, 2021 · Class II · Z-1131-2021: Zimmer Biomet is conducting a lot specific medical device recall for the Comprehensive Reverse Shoulder Central Screw, 25 MM Length. It has been determined through a complaint investigation that a 40 
- Nov 25, 2020 · Class II · Z-0619-2021: Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

## 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/K132239
Methodology: https://510kreport.com/methodology