# K070784: Inion Biorestore

- Pathway: 510(k) (Traditional)
- Applicant: Inion OY
- Decided: Jul 24, 2007 after 125 days
- Product code: LYC (Bone Grafting Material, Synthetic)
- Device class: 2
- Regulation: 21 CFR 872.3930
- 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 K941780 (1995). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 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.
- K040278: Perioglas-Bioglass Bone Graft Substitute, Novabone Products, LLC (2004) Summary page 1.
- K053022: Synthes (Usa) Chronos-Beta-TCP, Synthes (Usa) (2006) Summary page 1.
- K023998: Theriridge Block, Bone Graft Substitute, Therics, Inc. (2003) Summary page 1.
- K860983: Interpore 200 Porous Hydroxyapatite, Interpore Intl. (1986) Summary page 1.

## Indications for use
The INION BIORESTORETM implants are bone graft substitutes indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure; packing into bony voids or gaps to fill and/or augment dental intraosseous, oral and craniomaxillofacial defects. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone, including: e.g., periodontal/infrabony defects; alveolar ridge augmentation (sinusotomy, osteotomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; and craniofacial augmentation.

Source page: https://510kreport.com/device/K070784
Methodology: https://510kreport.com/methodology