# K052906: Zimmer Trabecular Metal Reverse Shoulder System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Dec 19, 2005 after 66 days
- Product code: PHX (Shoulder Prosthesis, Reverse Configuration)
- Device class: 2
- Regulation: 21 CFR 888.3660
- Recalls of this device: 12 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K911686 (1991). 26 ancestors in all.
216 later devices descend from it; 13 cite it directly.
1 of 243 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041873: Aequalis Reversed Shoulder Prosthesis, Tornier (2004) Summary page 1.
- K021478: Delta Shoulder, Depuy, Inc. (2003) Summary page 1.
- K041066: Encore Reverse Shoulder Prosthesis, Encore Medical L.P. (2005) Summary page 1.
- K041549: Zimmer Trabecular Metal Humeral Stem, Zimmer, Inc. (2004) Summary page 1.

## Most influential descendants
- K060704: Zimmer Trabecular Metal Reverse Shoulder System, Sizes 8MM and 10MM (2006), 207 descendants of its own
- K063569: Equinoxe Reverse Shoulder System (2007), 190 descendants of its own
- K073688: Equinoxe Reverse Shoulder System Fracture Humeral Adapter Tray and Locking Screw (2008), 177 descendants of its own
- K072804: Comprehensive RS Shoulder System (2007), 175 descendants of its own
- K080642: Comprehensive Reverse Shoulder (2008), 172 descendants of its own

## Recalls of this device
- May 22, 2017 · Class II · Z-3144-2017: Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instru
- Oct 17, 2013 · Class II · Z-1079-2014: As a result of complaints for disassociation of the TM Reverse Glenosphere from the Baseplate, Zimmer updated the related surgical technique and released a video to provide additional instructions to 
- Aug 1, 2013 · Class II · Z-2055-2013: Zimmer is initiating a lot specific recall of the Trabecular Metal" Reverse Glenosphere Distractor due to the potential of the device not functioning properly should it be utilized without proper lubr
- Sep 10, 2010 · Not classified · Z-0570-2011: The results of an investigation into complaints revealed that Trabecular Metal Humeral and/or Zimmer Trabecular Metal Reverse Humeral implants engaging in the canal earlier than expected could lead to
- Sep 10, 2010 · Not classified · Z-0574-2011: The results of an investigation into complaints revealed that Trabecular Metal Humeral and/or Zimmer Trabecular Metal Reverse Humeral implants engaging in the canal earlier than expected could lead to
- Sep 10, 2010 · Not classified · Z-0575-2011: The results of an investigation into complaints revealed that Trabecular Metal Humeral and/or Zimmer Trabecular Metal Reverse Humeral implants engaging in the canal earlier than expected could lead to
- Sep 10, 2010 · Not classified · Z-0571-2011: The results of an investigation into complaints revealed that Trabecular Metal Humeral and/or Zimmer Trabecular Metal Reverse Humeral implants engaging in the canal earlier than expected could lead to
- Sep 10, 2010 · Not classified · Z-0573-2011: The results of an investigation into complaints revealed that Trabecular Metal Humeral and/or Zimmer Trabecular Metal Reverse Humeral implants engaging in the canal earlier than expected could lead to
- Sep 10, 2010 · Not classified · Z-0576-2011: The results of an investigation into complaints revealed that Trabecular Metal Humeral and/or Zimmer Trabecular Metal Reverse Humeral implants engaging in the canal earlier than expected could lead to
- Jul 20, 2006 · Not classified · Z-1416-06: Components may not lock together as intended.
- Jul 20, 2006 · Not classified · Z-1418-06: Components may not lock together as intended.
- Jul 20, 2006 · Not classified · Z-1417-06: Components may not lock together as intended.

## Indications for use
The Zimmer Trabecular Metal Reverse Shoulder System is indicated for the following: 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. Hemiarthroplast/Totalapplication: - 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. 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 TrabecularMetal humeral and reverse base plate components are intended for either cemented or uncemented use. The reverse base plate requires two screws for initial fixation.

Source page: https://510kreport.com/device/K052906
Methodology: https://510kreport.com/methodology