# K132050: NB3D Bone Void Filler

- Pathway: 510(k) (Traditional)
- Applicant: Pioneer Surgical Technology, Inc.
- Decided: Feb 7, 2014 after 220 days
- Product code: MQV (Filler, Bone Void, Calcium Compound)
- Device class: 2
- Regulation: 21 CFR 888.3045
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K960978 (1996). 60 ancestors in all.
No later device cites it as a predicate yet.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111944: NB3D Bone Void Filler, Pioneer Surgical Technology, Inc. (2011) Summary page 3.
- K083033: Vitoss Bone Graft Substitute, Bone Graft Substitute Filled Canister, Foam & Bioactive Foam Bone Graft Substitute, Orthovita, Inc. (2008) Summary page 1.

## Recalls of this device
- Mar 9, 2026 · Class II · Z-1897-2026: Products were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life is four years.

## Indications for use
NB3D is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structures. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. NB3D is indicated to be gently packed into bony voids or gaps of the skeletal system (extremities and pelvis) un-hydrated or in conjunction with bone marrow aspirate or autogenous blood, or in the posterolateral spine in conjunction with bone marrow aspirate and autograft bone as a bone graft extender. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K132050
Methodology: https://510kreport.com/methodology