# K090083: Cytoflex Resorb, Model C03-0010 Through C03-090

- Pathway: 510(k) (Traditional)
- Applicant: Unicare Biomedical, Inc.
- Decided: Mar 23, 2009 after 70 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: 3 generations back to K973594 (1997). 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)
- K973594: Gore Resolut XT Regenerative Material, W. L. Gore & Associates, Inc. (1997) Summary page 1.
- K990363: Biomesh Biodegradable GTR Barrier, Samyang Corp. (1999) Summary page 1.
- K080308: Bio-Scaffold Bioscaff Alvelac Resobable Scaffold, Bioscaffold International Pte, Ltd. (2008)

## Most influential descendants
- K253317: Cytrans™ Elashield (2026), 0 descendants of its own

## Indications for use
CytoFlex® Resorb membranes are intended for use as a space-making barrier in the treatment of periodontal defects and maxillofacial guided tissue regeneration procedures, including preservation and regeneration of alveolar bone height and volume, ridge and. extraction site augmentation, sinus lifts, and treatment of associated cystic defects. It is also intended for use as a grafting material containment matrix.

Source page: https://510kreport.com/device/K090083
Methodology: https://510kreport.com/methodology