# K201561: Membrane Screws and Membrane Tacks

- Pathway: 510(k) (Traditional)
- Applicant: Neoss Limited
- Decided: Oct 5, 2020 after 117 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: 5 generations back to K952167 (1995). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130682: Meisinger Tacs (Meisinger Meitac-Kit), Meisinger Pins (Meisinger Master-Pin-Control-Kit, Basic-Kit, Hager& Meisinger GmbH (2013) Summary page 4.
- K093719: Pro-Fix Precision Fixation System Model PFM#, PFB#, PFT#, Osteogenics Biomedical, Inc. (2010) Summary page 4.

## Most influential descendants
- K243190: USTOMED Bone Fixation/Bone Augmentation Systems - PIN (2025), 0 descendants of its own

## Indications for use
Membrane Tacks and Membrane Screws are intended for fastening membranes during bone regenerative treatment. These membrane fastening means are in direct body contact, intended for temporary use only. Membrane fastening means are submerged and clinically implanted more than 30 days with an expected duration of implantation of three to nine months or until bone regeneration is complete taking into account which membrane and bone grafting materials are being used.

Source page: https://510kreport.com/device/K201561
Methodology: https://510kreport.com/methodology