# K012144: Cytoflex

- Pathway: 510(k) (Traditional)
- Applicant: Unicare Biomedical, Inc.
- Decided: Oct 1, 2001 after 83 days
- Product code: LYC (Bone Grafting Material, Synthetic)
- 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: 2 generations back to K922627 (1994). 6 ancestors in all.
2 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)
- K974752: Imtec/Biobarrier Membrane, Imtec Corp. (1998) Summary page 1.
- K964342: Cytoplast GBR, Osteogenics Co. (1997) Summary page 1.
- K922627: Gore-Tex Regenerative Material, W. L. Gore & Associates, Inc. (1994) Summary page 1.
- K935137: Tefgen-FD, American Custom Medical, Inc. (1994) Summary page 1.

## Most influential descendants
- K160493: Cytosurg non-resorbable PTFE Membrane, 25mm x 30mm, Cytosurg non-resorbable PTFE Membrane, 12mm x 24mm (2016), 1 descendant of its own
- K222549: OpenTex (2023), 0 descendants of its own

## Indications for use
A temporarily implantable material (non-resorbable) for use as a space-making barrier in the treatment of periodontal defects.

Source page: https://510kreport.com/device/K012144
Methodology: https://510kreport.com/methodology