# K071849: Allofuse Gel and Putty

- Pathway: 510(k) (Traditional)
- Applicant: Allosource, Inc.
- Decided: Dec 4, 2008 after 518 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: 2 generations back to K040980 (2004). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040419: Dynagraft II, Isotis Orthobiologics, Inc. (2005) Summary page 1.
- K041168: Allomatrix Putty, Wrightmedicaltechnologyinc (2004) Summary page 1.

## Most influential descendants
- K103036: Allofuse Plus (2011), 0 descendants of its own

## Recalls of this device
- Mar 25, 2014 · Class II · Z-1562-2014: The donor was hemodiluted.

## Indications for use
AlloFuse® is indicated for orthopedic applications as filler for gaps or voids that are not intrinsic to the stability of the bony structure. AlloFuse® is indicated to be packed gently into bony gaps in the skeletal system as a bone graft extender (extremities, spine, and pelvis) and as bony void filler of the extremities and pelvis. These defects may be surgically created or from the result of traumatic injury to the bone.

Source page: https://510kreport.com/device/K071849
Methodology: https://510kreport.com/methodology