# K201187: Cytoplast Titanium-Reinforced PTFE Membranes

- Pathway: 510(k) (Traditional)
- Applicant: Osteogenics Biomedical, Inc.
- Decided: Jan 23, 2021 after 267 days
- Product code: NPK (Barrier, Synthetic, Intraoral)
- Device class: 2
- Regulation: 21 CFR 872.3930
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K922627 (1994). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972278: Cytoplast Regentex Titanium 250, Osteogenics Co. (1997) Summary page 4.

## Most influential descendants
- K221851: Lumina-PTFE Titanium (2023), 0 descendants of its own

## Indications for use
Cytoplast™ Titanium‐Reinforced PTFE Membranes are a temporarily implantable material (non‐resorbable) indicated for use as a space‐making barrier in the treatment of alveolar and periodontal bony defect sites.

Source page: https://510kreport.com/device/K201187
Methodology: https://510kreport.com/methodology