# K050761: Zimmer Trabecular Metal Humeral Stem, Sizes 6MM and 8MM

- Pathway: 510(k) (Special)
- Applicant: Zimmer, Inc.
- Decided: Apr 11, 2005 after 18 days
- Product code: KWT (Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented)
- Device class: 2
- Regulation: 21 CFR 888.3650
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K790987 (1979). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041549: Zimmer Trabecular Metal Humeral Stem, Zimmer, Inc. (2004). Our reading of the summary gave K041459, FDA’s number for Lifepak 12 Defibrillator/Monitor (Medtronic Emergency Response Systems, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Zimmer TrabecularMetal Humeral Stem”.

## Recalls of this device
- 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

## 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 humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for total shoulder arthroplasty. Humeral 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/K050761
Methodology: https://510kreport.com/methodology