# K050766: Explant Osteonecrosis Intervention  Implant Removal System

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Trabecular
- Decided: May 26, 2005 after 62 days
- Product code: HWE (Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment)
- Device class: 1
- Regulation: 21 CFR 878.4820
- 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 Explant® Osteonecrosis Intervention Implant Removal Kit is intended for removal of a Trabecular MetaITM Osteonecrosis Intervention Implant.

Source page: https://510kreport.com/device/K050766
Methodology: https://510kreport.com/methodology