# K201781: Uni-FuZe-P Bone Putty

- Pathway: 510(k) (Traditional)
- Applicant: Zavation Medical Products, LLC
- Decided: Dec 28, 2020 after 181 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: 6 generations back to K960978 (1996). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 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.

## Most influential descendants
- K221726: Uni-FuZe-C Bone Strip (2023), 0 descendants of its own

## Indications for use
Uni-FuZe-P Bone Putty is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Uni-FuZe-P Bone Putty 1s indicated to be gently packed into bony voids or gaps of the skeletal system (i.e..extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and 1s replaced with bone during the healing process.

Source page: https://510kreport.com/device/K201781
Methodology: https://510kreport.com/methodology