# K163310: NovaBone IRM

- Pathway: 510(k) (Traditional)
- Applicant: Novabone Products, LLC
- Decided: Jan 18, 2017 after 56 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: 9 generations back to K960978 (1996). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112773: Novabne Putty Bioactive Synthetic Bone Graft, Novabone Products, LLC (2011) Summary page 4.

## Indications for use
NovaBone IRM — Bioactive Synthetic Bone Graft is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone IRM (Irrigation Resistant Matrix) 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/K163310
Methodology: https://510kreport.com/methodology