# K243949: OsteoFlo HydroFiber

- Pathway: 510(k) (Traditional)
- Applicant: SurGenTec, LLC
- Decided: May 28, 2025 after 156 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: 28 generations back to K841189 (1984). 438 ancestors in all.
No later device cites it as a predicate yet.
1 of 439 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140375: Mastergraft Putty, Mastergraft Strip, Medtronic Sofamor Danek USA, Inc. (2014) Summary page 5.
- K163621: Vitoss Bioactive (BA) Injectable, Orthovita, Inc. (2017) Summary page 5.
- K242797: OsteoFlo HydroFiber, SurGenTec, LLC (2024) Summary page 5.

## Indications for use
OsteoFlo HydroFiber is a bone void filler intended for use in osseous defects of the skeletal system that are not intrinsic to the stability of the bony structure i.e., the extremities, pelvis, intervertebral disc space, and posterolateral spine. These defects may be surgically created or the result of traumatic injury to the bone. OsteoFlo HydroFiber is indicated to be packed gently into bony voids or gaps of the extremities, pelvis, posterolateral spine, or intervertebral disc space, and may be used either standalone or in combination with autograft as a bone graft extender. The device is resorbed and replaced with host bone during the healing process. When used in intervertebral body fusion procedures, OsteoFlo HydroFiber must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler.

Source page: https://510kreport.com/device/K243949
Methodology: https://510kreport.com/methodology