# K041549: Zimmer Trabecular Metal Humeral Stem

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer, Inc.
- Decided: Sep 1, 2004 after 84 days
- Product code: KWT (Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3650
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K790987 (1979). 13 ancestors in all.
218 later devices descend from it; 2 cite it directly.
1 of 232 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982981: New Zimmer Shoulder System, Zimmer, Inc. (1998) Summary page 1.
- K992119: Bio-Modular Shoulder System, Biomet, Inc. (1999) Summary page 1.

## Most influential descendants
- K052906: Zimmer Trabecular Metal Reverse Shoulder System (2005), 216 descendants of its own
- 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

## Recalls of this device
- Jan 10, 2014 · Class II · Z-1092-2014: This single manufacturing lot has the potential for the bond strength between the Trabecular Metal material and substrate to be below the minimum required specification. Testing found bond strength ap
- 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-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
- Sep 17, 2009 · Not classified · Z-0177-2010: Some of the devices may possess a taper which will not mate with the humeral head, as intended.
- Sep 17, 2009 · Not classified · Z-0178-2010: Some of the devices may possess a taper which will not mate with the humeral head, as intended.

## Indications for use
Prosthetic replacement with this device may be 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 where arthrodesis or resectional arthoplasty is not acceptable. The assembled humcral component may be used alone for hemiarthroplasty or combined with the glenoid component for total shoulder arthroplasty. Niumeral heads with heights of 27mm or greater may be used for difficult clinical management problems involving rotator cuff deficiency where arthrodesis or conventional nonconstrained arthroplasty is not acceptable.

Source page: https://510kreport.com/device/K041549
Methodology: https://510kreport.com/methodology