# K121543: Zimmer Trabecular Metal Reverse Shoulder System, Base Plates & Humeral Stems

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Oct 11, 2012 after 139 days
- Product code: KWT (Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K911686 (1991). 28 ancestors in all.
14 later devices descend from it; 4 cite it directly.
0 of 43 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.
- K060704: Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM, Zimmer, Inc. (2006) Summary page 4.

## Most influential descendants
- K133378: Zimmer Trabecular Metal Reverse Shoulder System (2014), 11 descendants of its own
- 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

## Indications for use
The Zimmer Trabecular Metal Shoulder System is indicated for the following: Hemiarthroplasty/Total application: - 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 where arthrodesis or resectional arthroplasty is not acceptable. Reverse application: - 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. The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component or reverse components for total shoulder arthroplasty (conventional or reverse applications). The humeral components are intended for either cemented or uncemented use. The reverse base plate is intended for uncemented use, and requires two screws for fixation. When used in a total shoulder application, the all-polyethylene glenoid components are intended for cemented use only. In the USA, the Trabecular Metal Glenoid must be cemented under the base (see surgical technique for details) or fully cemented in place.

Source page: https://510kreport.com/device/K121543
Methodology: https://510kreport.com/methodology