# K140021: TI-OSS

- Pathway: 510(k) (Traditional)
- Applicant: Chiyewon
- Decided: Jun 5, 2015 after 518 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: 3 generations back to K871773 (1987). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113246: OCS-B, Nibec Company, Limited (2013) Summary page 4.

## Indications for use
Ti-oss® is intended for use in dental surgery. The product is recommended for the following surgeries * Augmentation or reconstructive treatment of alveolar ridge * Filling of periodontal defects * Filling of defects after root resection, apicoectomy, and cystectomy * Filling of extraction sockets to enhance preservation of the alveolar ridge * Elevation of maxillary sinus floor * Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR) * Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration

Source page: https://510kreport.com/device/K140021
Methodology: https://510kreport.com/methodology