# K130390: Comprehensive Convertible Glenoid

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing, Inc.
- Decided: Oct 9, 2013 after 236 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). 75 ancestors in all.
8 later devices descend from it; 3 cite it directly.
1 of 84 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113254: SMR Modular Glenoid-Metal-Back SMR Modular Glenoid-Liner SMR Modular Glenoid-Bone Screws, Lima Corporate S.P.A. (2012) Summary page 4.
- K030710: Bio-Modular Shoulder System, Biomet, Inc. (2003) Summary page 4.
- K080642: Comprehensive Reverse Shoulder, Biomet, Inc. (2008) Summary page 4.
- K120121: Comprehensive Reverse Shoulder-Mini Baseplate, Biomet, Inc. (2012) Summary page 4.

## Cited in the summary but kept off the family tree
- K892119: Quik-Dot C Reactive Protein, Ampcor, Inc. (1989). Our OCR of the scanned summary read K892119, FDA’s number for Quik-Dot C Reactive Protein (Ampcor, Inc.), which shares no word with the summary’s name for the device, “Bio-Modular Shoulder System”, apart from generic ones like “system”. Kept off the family tree. Summary page 4.

## Most influential descendants
- K200368: LINK Embrace Shoulder System - Reverse Configuration (2021), 3 descendants of its own
- K211729: Comprehensive® Convertible Glenoid - Vivacit-E Liner (2021), 2 descendants of its own
- K214001: Comprehensive® Shoulder System, Comprehensive® Reverse Shoulder System (2023), 1 descendant of its own
- K252404: Comprehensive Reverse Shoulder - HA Glenosphere Baseplates (2026), 0 descendants of its own
- K231445: LINK Embrace Shoulder System - Reverse Configuration (2023), 0 descendants 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.

## Indications for use
Anatomic Applications 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular. necrosis. Rheumatoid arthritis. Revision where other devices or treatments have failed. Correction of functional deformity. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate. Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate. : Reverss Applications The Comprehensive Reverse Shoulder is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previousty 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, fraclure, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. Comprehensive Convertible Glenoid Baseplate components are intended for cementless applications 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 application. Humeral components with porous coated surface coating are indicated for either cemented or.uncemented biological fixation applications.

Source page: https://510kreport.com/device/K130390
Methodology: https://510kreport.com/methodology