# K993493: The Autotac System

- Pathway: 510(k) (Traditional)
- Applicant: BioHorizons Implant Systems, Inc.
- Decided: Jan 7, 2000 after 84 days
- Product code: DZL (Screw, Fixation, Intraosseous)
- Device class: 2
- Regulation: 21 CFR 872.4880
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 2 cite 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)
- None. The FDA summary names its predicate without a number.
- (no number) Biovision GMBH LEADfix Bioresorbable Membrane Pin System: named in the summary without a submission number
- (no number) 3i BIO TACK: named in the summary without a submission number

## Most influential descendants
- K011675: The Autotac System (2001), 7 descendants of its own
- 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

## Recalls of this device
- Nov 19, 2012 · Class II · Z-0561-2013: The cleaning instructions provided may not be sufficient to remove residual contaminants after surgical use.

## 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/K993493
Methodology: https://510kreport.com/methodology