# K924408: Colla-Tec Absorbable Collagen Membrane

- Pathway: 510(k) (Traditional)
- Applicant: Colla-Tec, Inc.
- Decided: Aug 22, 1995 after 1,085 days
- Product code: LYC (Bone Grafting Material, Synthetic)
- Device class: 2
- Regulation: 21 CFR 872.3930
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
60 later devices descend from it; 1 cites 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)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K992216: Biomend Extend Absorbable Collagen Membrane, Biomend Absorbable Collagen Menbrane (1999), 59 descendants of its own
- 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

## Recalls of this device
- Mar 28, 2013 · Class II · Z-1301-2013: 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.
- Mar 28, 2013 · Class II · Z-1298-2013: 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.

Source page: https://510kreport.com/device/K924408
Methodology: https://510kreport.com/methodology