# K150211: EzFuze Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Vilex IN Tennessee, Inc.
- Decided: Nov 10, 2015 after 284 days
- Product code: HWC (Screw, Fixation, Bone)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K013888 (2002). 23 ancestors in all.
No later device cites it as a predicate yet.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141937: Trident Fusion Implant, Vilex IN Tennessee, Inc. (2014) Summary page 4.
- K070598: Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-Fuse, Memometal Technologies (2007) Summary page 4.
- K112197: Memometal Intra-Medullary Bone Fastener, Memometal Technologies (2011) Summary page 4.
- K091951: Hammerlock, Biomedical Ent., Inc. (2010) Summary page 4.
- K131640: Smooth or Threaded Metallic Bone Fastener, Biomedical Ent., Inc. (2013) Summary page 4.
- K111536: Metasurg Digifuse Implant, Metasurg (2011) Summary page 4.
- K112837: Vilex EZ-Staple (Memory Bone Fixation Staple), Vilex, Inc. (2012) Summary page 4.
- K022599: Newdeal K Wire, New Deal, S.A. (2002) Summary page 4.

## Indications for use
The EzFuze Implants have the following Indications for Use: Fixation of osteotomies and reconstruction of the lesser toes and lesser fingers following correction procedures for hammertoe, claw toe, mallet toe, and other deformities of the feet and hands.

Source page: https://510kreport.com/device/K150211
Methodology: https://510kreport.com/methodology