# K982951: Imtec Biopin

- Pathway: 510(k) (Traditional)
- Applicant: Imtec Corp.
- Decided: Jun 21, 1999 after 301 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: 2 generations back to K955369 (1996). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974392: Leadfix Bioresorbable Membrance Pin System, Biovision GmbH (1998) Summary page 1.
- K972480: 3I Bioresorbable Fixation Tack, Implant Innovations, Inc. (1997) Summary page 1.
- K974554: Synthes Resorbable Fixation System, Synthes (Usa) (1998) Summary page 1.

## Indications for use
The resorbable IMTEC BioPin is intended to stabilize bioresorbable guided tissue regeneration membranes during the healing process by providing an attachment mechanism.Its use is intended to avoid a second stage surgery required to remove nonresorbable tacks and pins.

Source page: https://510kreport.com/device/K982951
Methodology: https://510kreport.com/methodology