# K200064: OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft

- Pathway: 510(k) (Traditional)
- Applicant: SurGenTec, LLC
- Decided: Aug 14, 2020 after 214 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). 24 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110368: Novabone Putty - Bioactive Synthetic Bone Graft, Novabone Products, LLC (2011) Summary page 4.
- K101860: Novabone Putty- Bioactive Synthetic Bone Graft, Novabone Products, LLC (2010) Summary page 4.
- K082672: Novabone Putty-Bioactive Synthetic Bone Graft, Novabone Products, LLC (2008) Summary page 4.

## Most influential descendants
- K231716: OsteoFlo® HydroPutty™ (2023), 0 descendants of its own

## Indications for use
OsteoFlo® NanoPutty — Quadphasic Synthetic Bone Graft is indicated to fill bony voids or gaps of the skeletal system (i.e. the extremities and pelvis) that are not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or the result of traumatic injury to the bone. The device resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K200064
Methodology: https://510kreport.com/methodology