# K993610: Cytoplast Resorb, Models R-250, RP-250, RU-250, RPS-250, RPL-250

- Pathway: 510(k) (Traditional)
- Applicant: Osteogenics Biomedical, Inc.
- Decided: Mar 2, 2000 after 129 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: 1 generation back to K973594 (1997). 1 ancestor in all.
7 later devices descend from it; 2 cite 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)
- K973594: Gore Resolut XT Regenerative Material, W. L. Gore & Associates, Inc. (1997) Summary page 1.

## Most influential descendants
- K080308: Bio-Scaffold Bioscaff Alvelac Resobable Scaffold (2008), 5 descendants of its own
- K082419: Reoss Powder, Reoss Putty, Reoss Gel, Models R-1,RP-1, RG-1 (2009), 2 descendants of its own
- K101827: Osteoscaf (2011), 1 descendant of its own
- K090083: Cytoflex Resorb, Model C03-0010 Through C03-090 (2009), 1 descendant of its own
- K253317: Cytrans™ Elashield (2026), 0 descendants of its own

## Indications for use
As a space-making barrier in the treatment of periodontal defects and guided tissue regeneration procedures; As a grafting material containment membrane.

Source page: https://510kreport.com/device/K993610
Methodology: https://510kreport.com/methodology