# K070998: Inion Biorestore

- Pathway: 510(k) (Traditional)
- Applicant: Inion OY
- Decided: Oct 11, 2007 after 185 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). 16 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000149: Novabone-Bioglass Bone Graft Particulate, Usbiomaterials Corp. (2000) Summary page 1.
- K021336: Novabone-Resorbable Bone Graft Substitute, Novabone Products, LLC (2002) Summary page 1.
- K060432: Novabone Porous-Bone Graft Scaffold, Novabone Products, LLC (2006) Summary page 1.
- K052494: Novabone-Bioactive Synthetic Graft, Novabone Products, LLC (2005) Summary page 1.
- K040278: Perioglas-Bioglass Bone Graft Substitute, Novabone Products, LLC (2004) Summary page 1.

## Most influential descendants
- K090177: Inion Biorestore Biodegradable Bone Graft Substitute (2009), 2 descendants of its own
- K142463: Bio2 CLM BG Bioactive Scaffold (2014), 1 descendant of its own
- K191764: Inion BioRestore (2019), 0 descendants of its own
- K151876: Bio2 Fusion Implant System (2015), 0 descendants of its own

## Indications for use
The INION BIORESTORETM implants are bone graft substitutes indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. INION BIORESTORETM 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/K070998
Methodology: https://510kreport.com/methodology