# K140946: Novabone Macroform Bioactive Packable, Novabone Macroform Bioactive Composite

- Pathway: 510(k) (Traditional)
- Applicant: Novabone Products, LLC
- Decided: Aug 22, 2014 after 130 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). 25 ancestors in all.
6 later devices descend from it; 3 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090731: Novabone Porous - Synthetic Bone Graft Scaffold, Novabone Products, LLC (2009) Summary page 4.
- K060432: Novabone Porous-Bone Graft Scaffold, Novabone Products, LLC (2006) Summary page 4.

## Most influential descendants
- K180080: FIBERGRAFT BG Matrix Bone Graft Substitute (2018), 3 descendants of its own
- K213803: FIBERGRAFT Aeridyan Matrix Bone Graft Substitute (2022), 1 descendant of its own
- K253147: FIBERGRAFT™ BG Putty GPS Bone Graft Substitute FIBERGRAFT™ BG Putty Bone Graft Substitute FIBERGRAFT™ AERIDYAN™ Matrix Bone Graft Substitute FIBERGRAFT™ BG Matrix Bone Graft Substitute (2025), 0 descendants of its own
- K190371: Morpheus-C (2019), 0 descendants of its own
- K182670: FIBERGRAFT AERIDYAN Matrix Bone Graft Substitute (2018), 0 descendants of its own

## Indications for use
NovaBone MacroFORM bone graft devices are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone MacroFORM 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. NovaBone MacroFORM must be hydrated with autogenous bone marrow prior to implantation. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K140946
Methodology: https://510kreport.com/methodology