# K041613: Novabone - AR - Resorbable Bone Graft Substitute

- Pathway: 510(k) (Traditional)
- Applicant: Novabone Products, LLC
- Decided: Aug 25, 2004 after 71 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: 3 generations back to K960978 (1996). 13 ancestors in all.
84 later devices descend from it; 5 cite it directly.
0 of 98 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021336: Novabone-Resorbable Bone Graft Substitute, Novabone Products, LLC (2002) Summary page 1.
- K033994: Novabone-BBG-Resorbable Bone Graft Substitute, Novabone Products, LLC (2004) 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-AR Resorbable Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone-AR 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 tihe healing process.

Source page: https://510kreport.com/device/K041613
Methodology: https://510kreport.com/methodology