# K974392: Leadfix Bioresorbable Membrance Pin System

- Pathway: 510(k) (Traditional)
- Applicant: Biovision GmbH
- Decided: Jan 30, 1998 after 70 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 K955369 (1996). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960945: Imz Membrane Tack System, Interpore Intl. (1996) Summary page 1.
- K955369: Memfix, The Straumann Co. (1996) Summary page 1.

## Most influential descendants
- K982951: Imtec Biopin (1999), 0 descendants of its own

## Indications for use
The LEADfix Bioresorbable Membrane Pin System is designed to fixate and stabilize resorbable barrier membranes during the healing process by providing an attachment mechanism for the membrane to resident and adjacent bone at the surgical site. The LEADfix membrane pin is indicated for use with absorbable guided tissue and guided bone regeneration membranes.

Source page: https://510kreport.com/device/K974392
Methodology: https://510kreport.com/methodology