# K994137: Atrisorb-D Freeflow Bioabsorbable Guided Tissue Regeneration (GTR) Barrier with 4% Doxycycline

- Pathway: 510(k) (Traditional)
- Applicant: Atrix Laboratories, Inc.
- Decided: Sep 13, 2000 after 281 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: 1 generation back to K955838 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955838: Atrisorb Bioabsorbable Guided Tissue Regneration (GTR), Atrix Laboratories, Inc. (1996) Summary page 1.
- K982865: Atrisorb Bioabsorbable Guided Tissue Regeneration (GTR) Barrier Kit, Atrix Laboratories, Inc. (1998) Summary page 1.

## Indications for use
ATRISORB®-D FreeFlow™ Barrier is indicated for the surgical treatment of periodontal defects to aid in the regeneration and integration of tissue components in guided tissue regeneration procedures. ATRISORB®-D FreeFlow™ Barrier has been shown to reduce bacterial colonization of the barrier.

Source page: https://510kreport.com/device/K994137
Methodology: https://510kreport.com/methodology