# K101860: Novabone Putty- Bioactive Synthetic Bone Graft

- Pathway: 510(k) (Special)
- Applicant: Novabone Products, LLC
- Decided: Sep 1, 2010 after 61 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: 6 generations back to K960978 (1996). 22 ancestors in all.
47 later devices descend from it; 8 cite it directly.
0 of 70 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.
- K080009: Novabone Putty- Bioactive Synthetic Graft, Novabone Products, LLC (2008) Summary page 1.
- K082672: Novabone Putty-Bioactive Synthetic Bone Graft, Novabone Products, LLC (2008) Summary page 1.

## Most influential descendants
- 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
- K151154: FIBERGRAFT BG Morsels (2015), 31 descendants of its own
- K143533: Fibergraft BG Putty Bone Graft Substitute (2015), 31 descendants of its own

## Indications for use
NovaBone Putty - Bioactive Synthetic Bone 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, posterolateral 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; therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization.

Source page: https://510kreport.com/device/K101860
Methodology: https://510kreport.com/methodology