# K211729: Comprehensive® Convertible Glenoid - Vivacit-E Liner

- Pathway: 510(k) (Traditional)
- Applicant: Biomet Manufacturing Corp
- Decided: Nov 4, 2021 after 153 days
- Product code: PHX (Shoulder Prosthesis, Reverse Configuration)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: none
- 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.
2 later devices descend from it; 1 cites it directly.
1 of 79 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130390: Comprehensive Convertible Glenoid, Biomet Manufacturing, Inc. (2013) Summary page 4.

## Most influential descendants
- 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

## Indications for use
Anatomic Applications 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis. 2. Rheumatoid arthritis. 3. Revision where other devices or treatments have failed. 4. Correction of functional deformity. 5. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate. 6. Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate. Reverse 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 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. 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/K211729
Methodology: https://510kreport.com/methodology