# K033074: Inion GTR Biodegradable Membrane System

- Pathway: 510(k) (Traditional)
- Applicant: Inion, Ltd.
- Decided: Mar 31, 2004 after 184 days
- Product code: NPK (Barrier, Synthetic, Intraoral)
- 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 K955838 (1996). 3 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 12 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 2.
- K973594: Gore Resolut XT Regenerative Material, W. L. Gore & Associates, Inc. (1997) Summary page 2.
- K972817: Resor-Pin Resorbable Membrane Pin, Geistlich-Pharma (1998) Summary page 2.

## Most influential descendants
- 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
- K253317: Cytrans™ Elashield (2026), 0 descendants of its own

## Recalls of this device
- Mar 1, 2017 · Class II · Z-1478-2017: Aluminum pouch seal was noticed to be defective (slightly open).

## Indications for use
The Inion GTR TM Biodegradable Membrane System is indicated for the surgical treatment of periodontal defects to aid in the regeneration and integration of tissue components in guided tissue regeneration procedures (e.g. class II furcation defects, intrabony defects and recession type defects), for pre-implant and peri-implant surgery and for covering bone defects and empty sockets.

Source page: https://510kreport.com/device/K033074
Methodology: https://510kreport.com/methodology