# K052913: Ignite Bone Void Filler Kit

- Pathway: 510(k) (Special)
- Applicant: Wrightmedicaltechnologyinc
- Decided: Nov 7, 2005 after 21 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: 1 generation back to K020895 (2004). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020895: Allomatrix Model# 86, Wrightmedicaltechnologyinc (2004) Summary page 1.
- K041168: Allomatrix Putty, Wrightmedicaltechnologyinc (2004) Summary page 1.

## Most influential descendants
- K190482: IGNITE Bone Void Filler (2019), 0 descendants of its own

## Indications for use
IGNITE® Putty is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. IGNITE® Putty is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The Bone Graft Syringe is intended for use as a piston syringe for aspiration of bone marrow, autologous blood, plasma, or other body fluids. The syringe can be used to mix bone graft materials with aspirated fluids and deliver the composite graft material to the orthopedic surgical site

Source page: https://510kreport.com/device/K052913
Methodology: https://510kreport.com/methodology