# K103036: Allofuse Plus

- Pathway: 510(k) (Traditional)
- Applicant: Allosource, Inc.
- Decided: Jan 10, 2011 after 89 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: 4 generations back to K040980 (2004). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070751: Orthoblast II DBM Demineralized Bone Matrix Paste and Putty, Isotis Orthobiologics, Inc. (2007) Summary page 1.
- K050642: Orthoblast II Putty and Paste, Isotis Orthobiologics, Inc. (2005) Summary page 1.
- K071849: Allofuse Gel and Putty, Allosource, Inc. (2008) Summary page 1.

## Indications for use
For orthopedic use, AlloFuse Plus Paste and Putty are intended for use as an autograft extender (i.e. extremities, posterolateral spine and pelvis) and as a bone void filler (i.e. extremities and pelvis) for bony voids or gaps that are not intrinsic to the stability of the bony structure. The AlloFuse Plus products are indicated to be packed gently into bony defects of the skeletal system. These defects may be surgically created or from the result of traumatic injury to the bone.

Source page: https://510kreport.com/device/K103036
Methodology: https://510kreport.com/methodology