# K973594: Gore Resolut XT Regenerative Material

- Pathway: 510(k) (Traditional)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: Dec 17, 1997 after 86 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
No predicates in its family tree.
11 later devices descend from it; 4 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)
- None. The FDA summary names its predicate without a number.
- (no number) GORE RESOLUT Regenerative Material: named in the summary without a submission number

## Most influential descendants
- K033074: Inion GTR Biodegradable Membrane System (2004), 8 descendants of its own
- K993610: Cytoplast Resorb, Models R-250, RP-250, RU-250, RPS-250, RPL-250 (2000), 7 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
- K990363: Biomesh Biodegradable GTR Barrier (1999), 2 descendants of its own

## Indications for use
GORE RESOLUT XT Regenerative Material is a bioabsorbable, implantable material intended to aid in the healing of periodontal defects. It may also be used as a membrane for bone graft containment. When used over a bone graft, GORE RESOLUT XT Regenerative Material provides a stable barrier to graft material migration and provides a favorable environment for bone regeneration.

Source page: https://510kreport.com/device/K973594
Methodology: https://510kreport.com/methodology