# K050101: The Trabecular Metal Bone Stabilization Implant, Model 99-11197-XX-10

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Trabecular
- Decided: Apr 15, 2005 after 87 days
- Product code: HRS (Plate, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The Trabecular Metal Osteonecrosis Intervention Implant is indicated for use in patients with Stage I or Stage II osteonecrosis of the femoral head (Steinberg/UPenn System) and who would qualify for core decompression based upon physical and radiographic examination and medical history. The Trabecular Metal Osteonecrosis Intervention Implant may be used with or without bone graft.

Source page: https://510kreport.com/device/K050101
Methodology: https://510kreport.com/methodology