# K172502: Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing Corp
- Decided: Jan 3, 2018 after 138 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: 13 generations back to K911686 (1991). 76 ancestors in all.
20 later devices descend from it; 6 cite it directly.
1 of 97 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.
- K080642: Comprehensive Reverse Shoulder, Biomet, Inc. (2008) Summary page 4.
- K110708: Equinoxe Reverse Shoulder Compression Screw / 38MM and 42MM Glenosphere / Superior Augment Glenoid Plate, 10 Degrees..., Exactech, Inc. (2011) Summary page 4.
- K131353: Comprehensive Reverse Shoulder - Titanium Glenosphere, Biomet Manufacturing Corp (2013) Summary page 4.

## Most influential descendants
- K191746: SMR TT Augmented Glenoid System (2019), 12 descendants of its own
- K200171: SMR TT Augmented Glenoid System (2020), 11 descendants of its own
- K210717: Bone Screws dia. 5,0 mm (2021), 8 descendants of its own
- K220792: SMR Reverse Liner (2022), 7 descendants of its own
- K223876: SMR Shoulder System (2023), 3 descendants of its own

## Recalls of this device
- Aug 21, 2019 · Class II · Z-0520-2020: Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.

## 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 biclogical fixation applications.

Source page: https://510kreport.com/device/K172502
Methodology: https://510kreport.com/methodology