# K152071: NovaBone MacroFORM MIS Composite - 2.5cc, NovaBone MIS Cartridge Delivery System (cartridge handle only)

- Pathway: 510(k) (Special)
- Applicant: Novabone Products, LLC
- Decided: Aug 26, 2015 after 30 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: 8 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)
- K140946: Novabone Macroform Bioactive Packable, Novabone Macroform Bioactive Composite, Novabone Products, LLC (2014) Summary page 4.

## 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.c. the extremities and pelvis). These defects may be surgically created defects or deft d 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/K152071
Methodology: https://510kreport.com/methodology