# K080009: Novabone Putty- Bioactive Synthetic Graft

- Pathway: 510(k) (Traditional)
- Applicant: Novabone Products, LLC
- Decided: May 6, 2008 after 124 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 K960978 (1996). 10 ancestors in all.
71 later devices descend from it; 13 cite it directly.
0 of 82 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060728: Novabone Putty - Bioactive Synthetic Graft, Novabone Products, LLC (2006) Summary page 1.
- K021336: Novabone-Resorbable Bone Graft Substitute, Novabone Products, LLC (2002) Summary page 1.
- K052494: Novabone-Bioactive Synthetic Graft, Novabone Products, LLC (2005) Summary page 1.

## Most influential descendants
- K082672: Novabone Putty-Bioactive Synthetic Bone Graft (2008), 59 descendants of its own
- K101860: Novabone Putty- Bioactive Synthetic Bone Graft (2010), 47 descendants of its own
- K110368: Novabone Putty - Bioactive Synthetic Bone Graft (2011), 43 descendants of its own
- K112773: Novabne Putty Bioactive Synthetic Bone Graft (2011), 38 descendants of its own
- K132805: BG Morsels (2014), 33 descendants of its own

## Indications for use
NovaBone Putty - Bioactive Synthetic Graft is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone Putty is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. NovaBone Putty is not indicated for use in load-bearing applications. It does not possess sufficient mechanical strength to support load-bearing defects prior to hard tissue ingrowth. It should not be used for vertebroplasty or kyphoplasty procedures. In cases of fracture fixation or where load support is required, standard internal or external stabilization techniques must be followed to obtain rigid stabilization in all planes. NovaBone Putty must not be used to gain screw purchase or to stabilize screw placement.

Source page: https://510kreport.com/device/K080009
Methodology: https://510kreport.com/methodology