# K231716: OsteoFlo® HydroPutty™

- Pathway: 510(k) (Traditional)
- Applicant: SurGenTec, LLC
- Decided: Oct 2, 2023 after 111 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: 9 generations back to K960978 (1996). 25 ancestors in all.
No later device cites it as a predicate yet.
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.
- K200064: OsteoFlo NanoPutty-Quadphasic Synthetic Bone Graft, SurGenTec, LLC (2020) Summary page 4.

## Indications for use
OsteoFlo® HydroPutty™ is indicated for 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 defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The device provides a bone void filler that is resorbed and replaced with host bone during the healing process.

Source page: https://510kreport.com/device/K231716
Methodology: https://510kreport.com/methodology