# K083449: E-Matrix Graft Bone Extender

- Pathway: 510(k) (Traditional)
- Applicant: Pioneer Surgical Technology
- Decided: Jun 12, 2009 after 203 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). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081558: Pioneer Surgical Technology Nanoss BVF-E, Models 5, 10, 20CC, Pioneer Surgical Technology (2008) Summary page 2.
- K032288: Vitoss Scaffold Foam Bone Graft Material, Orthovita, Inc. (2003) Summary page 2.
- K071187: Microfuse Bone Void Filler, Globus Medical, Inc. (2007) Summary page 2.

## Indications for use
Pioneer E-Matrix Bone Void Filler is intended for bony voids or gaps that are not intrinsic to the stability of bony structure. The product is indicated to be gently packed into bony voids or gaps in the skeletal system (extremities and pelvis). These defects may be surgically created osseous defects or defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced by the growth of new bone during the healing process.

Source page: https://510kreport.com/device/K083449
Methodology: https://510kreport.com/methodology