# K152754: Comprehensive Vault Reconstruction System (VRS)

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing Corp
- Decided: May 16, 2016 after 235 days
- Product code: PHX (Shoulder Prosthesis, Reverse Configuration)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K911686 (1991). 53 ancestors in all.
22 later devices descend from it; 2 cite it directly.
1 of 76 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120121: Comprehensive Reverse Shoulder-Mini Baseplate, Biomet, Inc. (2012) 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
- 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

## Recalls of this device
- May 11, 2020 · Class II · Z-2300-2020: The product is being recalled due to the central screw drill seizing inside the Comprehensive VRS Inserter, which may lead to an extension of surgery to find a replacement device.

## Indications for use
Biomet Comprehensive Vault Reconstruction System 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 Vault Reconstruction System 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 Comprehensive Vault Reconstruction System glenoid baseplate components are intended for cementless application with the addition of screw fixation in patients with unusual anatomy and/or extensive bone loss which precludes the use of a standard glenoid baseplate component. 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. 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/K152754
Methodology: https://510kreport.com/methodology