# K093719: Pro-Fix Precision Fixation System Model PFM#, PFB#, PFT#

- Pathway: 510(k) (Traditional)
- Applicant: Osteogenics Biomedical, Inc.
- Decided: Mar 1, 2010 after 89 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
No predicates in its family tree.
5 later devices descend from it; 4 cite it directly.
0 of 6 devices 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.

## Most influential descendants
- K201561: Membrane Screws and Membrane Tacks (2020), 1 descendant of its own
- K250123: Master-Pin X (MP Pin with thread) (36BMP000030 / MP30) (2025), 0 descendants of its own
- K243190: USTOMED Bone Fixation/Bone Augmentation Systems - PIN (2025), 0 descendants of its own
- K171831: Intra-Lock Bone Fixation System (2017), 0 descendants of its own
- K161857: Salvin Tenting Screw System (2017), 0 descendants of its own

## Indications for use
The Pro-FixTM Precision Fixation System is used to stabilize, fixate and/or support bone grafts, bone filling materials and/or barrier membranes used for regeneration of bone in the oral cavity.

Source page: https://510kreport.com/device/K093719
Methodology: https://510kreport.com/methodology