# K080308: Bio-Scaffold Bioscaff Alvelac Resobable Scaffold

- Pathway: 510(k) (Abbreviated)
- Applicant: Bioscaffold International Pte, Ltd.
- Decided: Apr 14, 2008 after 69 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 K973594 (1997). 5 ancestors in all.
5 later devices descend from it; 2 cite 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)
- K993610: Cytoplast Resorb, Models R-250, RP-250, RU-250, RPS-250, RPL-250, Osteogenics Biomedical, Inc. (2000) Summary page 1.
- K033074: Inion GTR Biodegradable Membrane System, Inion, Ltd. (2004) Summary page 1.

## Most influential descendants
- 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
- K213260: CMFlexTM (2022), 0 descendants of its own

## Indications for use
Bio-Scaffold Bioscaff Alvelac Scaffold is a bioabsorbable implantable matrix intended for use as a space-making barrier in the treatment of periodontal defects and maxillofacial guided tissue regeneration procedures, including preservation and conservation 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/K080308
Methodology: https://510kreport.com/methodology