# K242299: NovaBone Putty - Synthetic Bioactive Bone Graft

- Pathway: 510(k) (Traditional)
- Applicant: Novabone Products, LLC
- Decided: Sep 25, 2024 after 54 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.
1 later device descends from it; 1 cites it directly.
1 of 375 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222276: CONDUIT Cages; FIBERGRAFT BG Putty, Depuy Spine (2022) Summary page 5.
- 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.

## Most influential descendants
- K243474: MagnetOs MIS (2025), 0 descendants of its own

## Indications for use
NovaBone Putty - Bioactive Synthetic Bone Graft is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone Putty is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities, posterolateral spine, pelvis, and intervertebral disc space). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. When used in intervertebral disc space, NovaBone Putty must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler. NovaBone Putty is not indicated for use in load-bearing applications; therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization.

Source page: https://510kreport.com/device/K242299
Methodology: https://510kreport.com/methodology