# K021336: Novabone-Resorbable Bone Graft Substitute

- Pathway: 510(k) (Traditional)
- Applicant: Novabone Products, LLC
- Decided: Jul 25, 2002 after 90 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: 2 generations back to K960978 (1996). 3 ancestors in all.
162 later devices descend from it; 13 cite it directly.
0 of 166 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980817: Pro Osteon Implant 500R Resorbable Bone Graft Substitute Model Numbers 5RG05, 5RG10, 5RG15, 5G15L, 5RG20, 5RG30, 5RG30L, Interpore Intl. (1998) Summary page 4.
- K963562: Wright Plaster of Paris Pellets, Wrightmedicaltechnologyinc (1997) Summary page 4.

## Most influential descendants
- K052494: Novabone-Bioactive Synthetic Graft (2005), 123 descendants of its own
- K060728: Novabone Putty - Bioactive Synthetic Graft (2006), 120 descendants of its own
- K041613: Novabone - AR - Resorbable Bone Graft Substitute (2004), 84 descendants of its own
- K080009: Novabone Putty- Bioactive Synthetic Graft (2008), 71 descendants of its own
- K082672: Novabone Putty-Bioactive Synthetic Bone Graft (2008), 59 descendants of its own

## Indications for use
NovaBone Resorbable Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone 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 the healing process.

Source page: https://510kreport.com/device/K021336
Methodology: https://510kreport.com/methodology