# K973180: Imtec Bone Tac

- Pathway: 510(k) (Traditional)
- Applicant: Imtec Corp.
- Decided: Nov 18, 1997 after 85 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 K952167 (1995). 2 ancestors in all.
10 later devices descend from it; 4 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952167: Imz Bone Tack System, Interpore Intl. (1995) Summary page 1.
- K960945: Imz Membrane Tack System, Interpore Intl. (1996) Summary page 1.

## Most influential descendants
- K022790: The Autotac System Titanium Tack (2002), 6 descendants of its own
- K092855: Miltex Membrane Tack Kit (2009), 4 descendants of its own
- K130682: Meisinger Tacs (Meisinger Meitac-Kit), Meisinger Pins (Meisinger Master-Pin-Control-Kit, Basic-Kit (2013), 3 descendants of its own
- K100182: Salvin Dental Specialties Fixation Screw (2010), 2 descendants of its own
- K201561: Membrane Screws and Membrane Tacks (2020), 1 descendant of its own

## Indications for use
The IMTEC Bone Tac System is designed to stabilize a Barrier Membrane onto a region of cortical plate. This may be used in craniofacial, maxillofacial or mandibular bone. Considerations such as quality of bone, bone type, functional loads exerted, general patient health and others should be carefully evaluated prior to use.

Source page: https://510kreport.com/device/K973180
Methodology: https://510kreport.com/methodology