# K250521: NanoBone® SBX Putty ; NanoBone® QD

- Pathway: 510(k) (Traditional)
- Applicant: Biocomposites, Ltd.
- Decided: Apr 7, 2025 after 45 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.
No later device cites it as a predicate yet.
1 of 374 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.

## Indications for use
NanoBone® SBX Putty is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities, posterolateral spine, intervertebral disc space, and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. NanoBone® SBX Putty resorbs and is replaced with bone during the healing process. When used in intervertebral body fusion procedures, NanoBone® SBX Putty must be used with an intervertebral body fusion device cleared by FDA for use with a bone void filler. NanoBone® QD is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities, posterolateral spine, intervertebral disc space, and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. NanoBone® QD resorbs and is replaced with bone during the healing process. When used in intervertebral body fusion procedures, NanoBone® QD 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/K250521
Methodology: https://510kreport.com/methodology