# K080642: Comprehensive Reverse Shoulder

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Jul 9, 2008 after 125 days
- Product code: PHX (Shoulder Prosthesis, Reverse Configuration)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: 17 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K911686 (1991). 51 ancestors in all.
172 later devices descend from it; 24 cite it directly.
1 of 224 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072804: Comprehensive RS Shoulder System, Biomet Manufacturing Corp (2007) Summary page 4.
- K053274: Anatomical Shoulder Inverse/Reverse, Zimmer GmbH (2006) Summary page 4.
- K063569: Equinoxe Reverse Shoulder System, Exactech, Inc. (2007) Summary page 4.
- K073688: Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw, Exactech, Inc. (2008)
- K041066: Encore Reverse Shoulder Prosthesis, Encore Medical L.P. (2005) Summary page 4.
- K051075: Encore Reverse Shoulder Prosthesis, Encore Medical L.P. (2005) Summary page 4.
- K052906: Zimmer Trabecular Metal Reverse Shoulder System, Zimmer, Inc. (2005) Summary page 4.

## Most influential descendants
- K110599: Aequalis Ascend Modular Reverse Shoulder System (2011), 108 descendants of its own
- K112615: Aequalis Ascend Modular Reverse Shoulder System (2011), 97 descendants of its own
- K122698: Aequalis Ascend Flex Shoulder System (2013), 96 descendants of its own
- K120121: Comprehensive Reverse Shoulder-Mini Baseplate (2012), 69 descendants of its own
- K093803: Bio-Modular Reverse Sholder (2010), 61 descendants of its own

## Recalls of this device
- Apr 17, 2020 · Class II · Z-2144-2020: Potential presence of elevated endotoxin levels that exceed the specification limit
- Mar 13, 2020 · Class II · Z-1750-2020: There were unknown bioburden levels prior to sterilization, which may affect sterility of the product.
- Feb 17, 2017 · Class II · Z-1859-2017: Endotoxin levels higher than process maximum limits were discovered in the identified polyethylene components.
- Dec 20, 2016 · Class I · Z-1103-2017: Higher than anticipated rate of fracturing due to design. Risk of revision surgery due to fracturing.
- May 15, 2013 · Class II · Z-1548-2013: Biomet has initiated this action following an investigation which identified that the slot on the resection guide is offset in the wrong direction. When the slot on the resection guide is offset in th
- Apr 22, 2011 · Not classified · Z-2541-2011: The firm is initiating this recall following an investigation which identified the rare possibility that certain units of Comprehensive Reverse Shoulder Humeral Trays may contain a locking ring that i
- Apr 22, 2011 · Not classified · Z-2544-2011: The firm is initiating this recall following an investigation which identified the rare possibility that certain units of Comprehensive Reverse Shoulder Humeral Trays may contain a locking ring that i
- Apr 22, 2011 · Not classified · Z-2548-2011: The firm is initiating this recall following an investigation which identified the rare possibility that certain units of Comprehensive Reverse Shoulder Humeral Trays may contain a locking ring that i
- Apr 22, 2011 · Not classified · Z-2549-2011: The firm is initiating this recall following an investigation which identified the rare possibility that certain units of Comprehensive Reverse Shoulder Humeral Trays may contain a locking ring that i
- Apr 22, 2011 · Not classified · Z-2547-2011: The firm is initiating this recall following an investigation which identified the rare possibility that certain units of Comprehensive Reverse Shoulder Humeral Trays may contain a locking ring that i
- Apr 22, 2011 · Not classified · Z-2546-2011: The firm is initiating this recall following an investigation which identified the rare possibility that certain units of Comprehensive Reverse Shoulder Humeral Trays may contain a locking ring that i
- Apr 22, 2011 · Not classified · Z-2545-2011: The firm is initiating this recall following an investigation which identified the rare possibility that certain units of Comprehensive Reverse Shoulder Humeral Trays may contain a locking ring that i
- Apr 22, 2011 · Not classified · Z-2550-2011: The firm is initiating this recall following an investigation which identified the rare possibility that certain units of Comprehensive Reverse Shoulder Humeral Trays may contain a locking ring that i
- Apr 22, 2011 · Not classified · Z-2542-2011: The firm is initiating this recall following an investigation which identified the rare possibility that certain units of Comprehensive Reverse Shoulder Humeral Trays may contain a locking ring that i
- Apr 22, 2011 · Not classified · Z-2543-2011: The firm is initiating this recall following an investigation which identified the rare possibility that certain units of Comprehensive Reverse Shoulder Humeral Trays may contain a locking ring that i
- Sep 13, 2010 · Not classified · Z-0712-2011: The firm received complaints regarding fracturing of the device.
- Sep 13, 2010 · Not classified · Z-0713-2011: The firm received complaints regarding fracturing 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. Intertok® 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/K080642
Methodology: https://510kreport.com/methodology