# K030052: OSTIM

- Pathway: 510(k) (Traditional)
- Applicant: Heraeus Kulzer, Inc.
- Decided: Dec 6, 2004 after 700 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Ostim is intended as a filling or reconstruction material for repair of bony defects in oral. gnathic and facial applications in the following indications: * Filling of intraoral bony defects such as those resulting from cytectomies, tooth tip resections, extractions or surgical tooth removal. * Augmentations in the area of the alveolar processes and maxillary sinuses. * Filling of periodontal defects.

Source page: https://510kreport.com/device/K030052
Methodology: https://510kreport.com/methodology