# K955838: Atrisorb Bioabsorbable Guided Tissue Regneration (GTR)

- Pathway: 510(k) (Traditional)
- Applicant: Atrix Laboratories, Inc.
- Decided: Mar 21, 1996 after 90 days
- Product code: NPK (Barrier, Synthetic, Intraoral)
- 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
No predicates in its family tree.
10 later devices descend from it; 3 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)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K033074: Inion GTR Biodegradable Membrane System (2004), 8 descendants of its own
- 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

Source page: https://510kreport.com/device/K955838
Methodology: https://510kreport.com/methodology