# K960945: Imz Membrane Tack System

- Pathway: 510(k) (Traditional)
- Applicant: Interpore Intl.
- Decided: May 24, 1996 after 77 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
No predicates in its family tree.
13 later devices descend from it; 2 cite it directly.
0 of 14 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) Straumann, USA MemFix™ Mini-Screw Kits: named in the summary without a submission number

## Most influential descendants
- K973180: Imtec Bone Tac (1997), 10 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
- K100182: Salvin Dental Specialties Fixation Screw (2010), 2 descendants of its own

## Indications for use
The Membrane Tack is a titanium alloy, machined, miniature nail designed to stabilize guided tissue regeneration membranes during the healing process by providing an attachment mechanism for the membrane to resident and adjacent bone at the surgical site. The guided tissue regeneration membranes are intended for use in wrapping bone or cartilage, or in soft tissue defects when bony or soft tissue ingrowth and attachment is required Guided tissue regeneration membranes are also appropriate for augmentation of slight tissue deficiencies. These are medical devices currently cleared by FDA and commercially available for sale in the United States. While not yet classified by FDA, the FDA Dental Advisory Panel has recommended a Class II Classification for guided tissue regeneration devices, both resorbable and non-resorbable. The Membrane Tack is designed for implantation during the healing period during which tissue regeneration takes place. It is not intended for long-term implantation, but should be removed upon completion of the healing process.

Source page: https://510kreport.com/device/K960945
Methodology: https://510kreport.com/methodology