# K051617: Novabone Putty - Resorbable Bone Void Filler

- Pathway: 510(k) (Traditional)
- Applicant: Novabone Products, LLC
- Decided: Mar 6, 2006 after 262 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: 4 generations back to K960978 (1996). 14 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 20 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.
- K041613: Novabone - AR - Resorbable Bone Graft Substitute, Novabone Products, LLC (2004)

## Most influential descendants
- K063596: Perioglas Putty-Bioactive Bone Graft Gel (2007), 4 descendants of its own
- K081432: Healos II Bone Graft Substitute (2008), 3 descendants of its own
- K101827: Osteoscaf (2011), 1 descendant of its own
- K213260: CMFlexTM (2022), 0 descendants of its own
- K093390: Healos Dental Bone Graft Substitute (Also Called Healos or Healos II) Model 6008, 6025 (2010), 0 descendants of its own

## Indications for use
NovaBone Putty - Resorbable Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone Putty 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.

Source page: https://510kreport.com/device/K051617
Methodology: https://510kreport.com/methodology