# K092788: Periophil Biphasic

- Pathway: 510(k) (Traditional)
- Applicant: Cytophil, Inc.
- Decided: Dec 18, 2009 after 99 days
- Product code: LYC (Bone Grafting Material, Synthetic)
- Device class: 2
- Regulation: 21 CFR 872.3930
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K990131 (1999). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051885: MBCP, Biomatlante (2005) Summary page 2.

## Recalls of this device
- Jan 11, 2012 · Not classified · Z-1012-2012: Cytophil Corporation is recalling Periophil Biphasic Periophil Biphasic, Periobase Biphasic, and Periobone Biphasic because devices were inadvertently shipped after receiving an inadequate dose of rad

## Indications for use
Periophil Biphasic is intended, for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Periophil Biphasic can be used with autogenous bone grafting materials. Typical uses include: periodontal/infrabony defects, ridge augmentation, extraction sites (implant preparation/placement), sinus lifts, and cystic cavities.

Source page: https://510kreport.com/device/K092788
Methodology: https://510kreport.com/methodology