# K111944: NB3D Bone Void Filler

- Pathway: 510(k) (Traditional)
- Applicant: Pioneer Surgical Technology, Inc.
- Decided: Nov 22, 2011 after 137 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: 8 generations back to K960978 (1996). 55 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 57 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091031: Pioneer Surgical Nanoss BVF-E, Pioneer Surgical Technology (2009) Summary page 2.
- K081439: Vitoss Bioactive Foam Pack Bone Graft Substitute, Orthovita, Inc. (2008) Summary page 2.
- K071046: Synthes Chronos Composite, Synthes (Usa) (2007) Summary page 2.
- K082166: Mastergraft Strip, Medtronic Sofamor Danek (2009) Summary page 2.

## Most influential descendants
- K132050: NB3D Bone Void Filler (2014), 0 descendants of its own

## Indications for use
NB3D Bone Void Filler is intended for bony voids or gaps that are not intrinsic to the stability of bony structure. These defects may be surgically created osseous defects or defects created fromn traumatic injury to the bone. The product is intended to be used in conjunction with bone mnarrow aspirate and autograft bone as a bone graft extender and gently packed into bony voids or gaps in the posterolateral spine. NB3D provides an open void/gap filler that resorbs and is replaced by the growth of new bone during the healing process.

Source page: https://510kreport.com/device/K111944
Methodology: https://510kreport.com/methodology