# K221726: Uni-FuZe-C Bone Strip

- Pathway: 510(k) (Traditional)
- Applicant: Zavation Medical Products, LLC
- Decided: Jan 18, 2023 after 218 days
- Product code: MQV (Filler, Bone Void, Calcium Compound)
- Device class: 2
- Regulation: 21 CFR 888.3045
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K960978 (1996). 34 ancestors in all.
No later device cites it as a predicate yet.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051386: Mastergraft Putty Bone Void Filler, Medtronic Vascular (2005) Summary page 4.
- K082166: Mastergraft Strip, Medtronic Sofamor Danek (2009) Summary page 4.
- K201781: Uni-FuZe-P Bone Putty, Zavation Medical Products, LLC (2020) Summary page 4.

## Indications for use
Uni-FuZe-C Bone Strip is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Uni-FuZe-C Bone Strip resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K221726
Methodology: https://510kreport.com/methodology