# K240458: Synthetic Bone Putty

- Pathway: 510(k) (Traditional)
- Applicant: Ventris Medical
- Decided: Mar 7, 2024 after 20 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: 26 generations back to K841189 (1984). 373 ancestors in all.
2 later devices descend from it; 1 cites it directly.
1 of 376 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203714: NuVasive Thoracolumbar Interbody Systems: NuVasive CoRoent Thoracolumbar System, NuVasive CoRoent XL Interfixated System, Brigade System, Brigade Lateral System, BASE Interfixated Titanium System, Coalesce Thoracolumbar Interbody Fusion System, NuVasive Cohere Thoracolumbar Interbody System, NuVasive Modulus XLIF Interbody System, NuVasive Modulus TLIF Interbody System, NuVasive Modulus ALIF System, NuVasive Attrax Putty, Nu Vasive, Incorporated (2021) Summary page 5.
- K222276: CONDUIT Cages; FIBERGRAFT BG Putty, Depuy Spine (2022) Summary page 5.

## Most influential descendants
- K242797: OsteoFlo HydroFiber (2024), 1 descendant of its own
- K243949: OsteoFlo HydroFiber (2025), 0 descendants of its own

## Indications for use
Synthetic Bone Putty 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. These defects may be surgically created or the result of traumatic injury to the bone. Synthetic Bone Putty 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, Synthetic Bone Putty 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/K240458
Methodology: https://510kreport.com/methodology