# K992216: Biomend Extend Absorbable Collagen Membrane, Biomend Absorbable Collagen Menbrane

- Pathway: 510(k) (Special)
- Applicant: Integra Lifesciences Corp.
- Decided: Jul 26, 1999 after 25 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: 1 generation back to K924408 (1995). 1 ancestor in all.
59 later devices descend from it; 2 cite it directly.
0 of 61 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924408: Colla-Tec Absorbable Collagen Membrane, Colla-Tec, Inc. (1995) Summary page 1.

## Most influential descendants
- K042197: Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone Regeneration (2004), 58 descendants of its own
- K050446: Bio-Gide Resorbable Bilayer Membrane for Guided Tissue and Bone (2005), 53 descendants of its own
- K112572: Geistlich Combi-Kit Collegen (2011), 23 descendants of its own
- K122894: Geistlich Bio-Oss, Geistlich Bio-Oss Collagen, Geistlich Combi-Kit Collagen, Geistlich Perio System Combi Pack, Geistlic (2013), 21 descendants of its own
- K061244: Mucograft (2006), 16 descendants of its own

## Recalls of this device
- Mar 28, 2013 · Class II · Z-1299-2013: Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

## Indications for use
BioMend Extend™ Absorbable Collagen Membrane is an absorbable, implantable material that is indicated for guided tissue regeneration procedures in periodontal defects to enhance regeneration of the periodontal apparatus.

Source page: https://510kreport.com/device/K992216
Methodology: https://510kreport.com/methodology