# K091424: Osta Maxigro and Regigro

- Pathway: 510(k) (Abbreviated)
- Applicant: Osta Technologies
- Decided: Aug 18, 2010 after 462 days
- Product code: NPM (Bone Grafting Material, Animal Source)
- 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: 2 generations back to K871773 (1987). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033815: Bio-Oss, Bio-Oss Blocks and Bio-Oss Collagen, Geistlich-Pharma (2004) Summary page 1.

## Indications for use
1. Augmentation or reconstructive treatment of alveolar ridge 2. Filling of periodontal defects 3. Filling of defects after root resection, apicectomy, and cystectomy 4. Filling of extraction sockets to enhance preservation of the alveolar ridge 5. Elevation of maxillary sinus floor 6. Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)

Source page: https://510kreport.com/device/K091424
Methodology: https://510kreport.com/methodology