# K171831: Intra-Lock Bone Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Intra-Lock International, Inc.
- Decided: Oct 26, 2017 after 128 days
- Product code: DZL (Screw, Fixation, Intraosseous)
- Device class: 2
- Regulation: 21 CFR 872.4880
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K093719 (2010). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093719: Pro-Fix Precision Fixation System Model PFM#, PFB#, PFT#, Osteogenics Biomedical, Inc. (2010) Summary page 4.

## Indications for use
The Intra-Lock Bone Fixation System is indicated for the stabilization and fixation of bone graft, bone filling materials, and/or barrier membranes used to regenerate bone in the oral cavity.

Source page: https://510kreport.com/device/K171831
Methodology: https://510kreport.com/methodology