# K242797: OsteoFlo HydroFiber

- Pathway: 510(k) (Traditional)
- Applicant: SurGenTec, LLC
- Decided: Dec 23, 2024 after 98 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: 27 generations back to K841189 (1984). 437 ancestors in all.
1 later device descends from it; 1 cites it directly.
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.
- K240458: Synthetic Bone Putty, Ventris Medical (2024) Summary page 5.

## Most influential descendants
- K243949: OsteoFlo HydroFiber (2025), 0 descendants of its own

## 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 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 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/K242797
Methodology: https://510kreport.com/methodology