# K133378: Zimmer Trabecular Metal Reverse Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: May 12, 2014 after 189 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: 9 generations back to K911686 (1991). 29 ancestors in all.
11 later devices descend from it; 1 cites it directly.
0 of 41 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052906: Zimmer Trabecular Metal Reverse Shoulder System, Zimmer, Inc. (2005) Summary page 4.
- K121543: Zimmer Trabecular Metal Reverse Shoulder System, Base Plates & Humeral Stems, Zimmer, Inc. (2012) Summary page 4.

## Most influential descendants
- K181611: Comprehensive Reverse Shoulder System (2018), 10 descendants of its own
- K210533: Inset Reverse Total Shoulder System (2021), 3 descendants of its own
- K200368: LINK Embrace Shoulder System - Reverse Configuration (2021), 3 descendants of its own
- K252221: Inset Reverse Total Shoulder System (2025), 1 descendant of its own
- K240876: Identity Shoulder System (2024), 1 descendant of its own

## Indications for use
The Trabecular Metal™ Reverse Shoulder System Vivacit-E™ Vitamin E Highly Crosslinked Polyethylene Liners are indicated for: the treatment of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; ununited humeral head fractures of long duration; irreducible 3-and 4-part proximal humeral fractures; avascular necrosis of the humeral head, or other difficult clinical management problems (such as a failed total shoulder arthroplasty or grossly rotator cuff deficient joint) where arthrodesis or resectional arthroplasty is not acceptable.

Source page: https://510kreport.com/device/K133378
Methodology: https://510kreport.com/methodology