# K193373: Comprehensive® Reverse Shoulder

- Pathway: 510(k) (Traditional)
- Applicant: Biomet, Inc.
- Decided: Apr 15, 2020 after 132 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: 13 generations back to K911686 (1991). 78 ancestors in all.
20 later devices descend from it; 7 cite it directly.
1 of 99 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 5.
- K113069: Comprehensive Reverse Shoulder Humeral Tray, Biomet Manufacturing Corp (2012) Summary page 5.
- K113121: Comprehensive Reverse Shoulder, Biomet Manufacturing, Inc. (2011) Summary page 5.
- K120121: Comprehensive Reverse Shoulder-Mini Baseplate, Biomet, Inc. (2012) Summary page 5.
- K131353: Comprehensive Reverse Shoulder - Titanium Glenosphere, Biomet Manufacturing Corp (2013) Summary page 5.
- K132239: Comprehensive Reverse Shoulder Screws, Biomet Manufacturing Corp (2013) Summary page 6.
- K152754: Comprehensive Vault Reconstruction System (VRS), Biomet Manufacturing Corp (2016) Summary page 6.

## Most influential descendants
- K212737: INHANCE™ Reverse Shoulder System (2022), 9 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
- K243643: restor3d Reverse Total Shoulder Arthroplasty System (2025), 1 descendant of its own
- K241817: InSet Total Shoulder System (2025), 1 descendant of its own

## Recalls of this device
- 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.
- 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 

## 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 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. 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 patients without material sensitivity to cobalt alloy. 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. 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 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/K193373
Methodology: https://510kreport.com/methodology