# K011675: The Autotac System

- Pathway: 510(k) (Special)
- Applicant: BioHorizons Implant Systems, Inc.
- Decided: Jun 22, 2001 after 23 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 K993493 (2000). 1 ancestor in all.
7 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993493: The Autotac System, BioHorizons Implant Systems, Inc. (2000) Summary page 2.

## 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
- K201561: Membrane Screws and Membrane Tacks (2020), 1 descendant of its own
- K243190: USTOMED Bone Fixation/Bone Augmentation Systems - PIN (2025), 0 descendants of its own

## Indications for use
The AUTOTAC System™ is intended to fixate or stabilize bioresorbable barrier membranes used for regeneration of tissue and/or bone in the oral cavity or in other clinical situations that require membrane use/fixation.

Source page: https://510kreport.com/device/K011675
Methodology: https://510kreport.com/methodology