# K070751: Orthoblast II DBM Demineralized Bone Matrix Paste and Putty

- Pathway: 510(k) (Traditional)
- Applicant: Isotis Orthobiologics, Inc.
- Decided: Oct 15, 2007 after 210 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: 3 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.
- K050642: Orthoblast II Putty and Paste, Isotis Orthobiologics, Inc. (2005) Summary page 1.

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

## Indications for use
For orthopedic use, the OrthoBlast It Paste and Putty are intended for use as an autograft extender (extremities, spine and pelvis) and as a bone void filler (extremities and pelvis) for bony voids or gaps that are not intrinsic to the stability of the bony structure. The OrthoBlast IIproducts 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/K070751
Methodology: https://510kreport.com/methodology