# K110925: Novabone Macropor-SI+ - Bioactive Bone Graft

- Pathway: 510(k) (Traditional)
- Applicant: Novabone Products, LLC
- Decided: Jul 5, 2011 after 95 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: 7 generations back to K960978 (1996). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 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.
- K101860: Novabone Putty- Bioactive Synthetic Bone Graft, Novabone Products, LLC (2010) Summary page 1.
- K060432: Novabone Porous-Bone Graft Scaffold, Novabone Products, LLC (2006) Summary page 1.
- K090731: Novabone Porous - Synthetic Bone Graft Scaffold, Novabone Products, LLC (2009) Summary page 1.

## Indications for use
NovaBone NMacroPor-SiW- Bioactive Bone Graft is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone MacroPor-Si' is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities 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 MacroPor-Si' 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/K110925
Methodology: https://510kreport.com/methodology