# K130661: Zimmer Trabecular Metal Reverse Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: May 9, 2013 after 58 days
- Product code: PHX (Shoulder Prosthesis, Reverse Configuration)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K911686 (1991). 30 ancestors in all.
No later device cites it as a predicate yet.
0 of 31 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.
- K121543: Zimmer Trabecular Metal Reverse Shoulder System, Base Plates & Humeral Stems, Zimmer, Inc. (2012) Summary page 4.
- K122692: Zimmer Trabecular Metal Reverse Shoulder System, Non-Porous Humeral Stems, Zimmer, Inc. (2012) Summary page 4.

## Recalls of this device
- Oct 10, 2019 · Class II · Z-0299-2020: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
- Dec 10, 2013 · Class II · Z-0609-2014: Zimmer is initiating a lot specific recall of the CPT Hip Stem, Versys Build-Up Block, and Trabecular Metal Reverse Glenosphere medical devices due to reports of the products being packaged in the inc

## 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/K130661
Methodology: https://510kreport.com/methodology