# K962624: Resolut Regenerative Material

- Pathway: 510(k) (Traditional)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: Oct 3, 1996 after 90 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.
3 later devices descend from it; 1 cites it directly.
0 of 4 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) RESOLUT Regenerative Material: named in the summary without a submission number
- (no number) CAPSET Calcium Sulfate Bone Graft Barrier: named in the summary without a submission number
- (no number) Micro Titanium Augmentation Mesh: named in the summary without a submission number

## Most influential descendants
- K990363: Biomesh Biodegradable GTR Barrier (1999), 2 descendants 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

## Indications for use
RESOLUT 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, RESOLUT Regenerative Material provides a stable barrier to graft material migration and provides a favorable environment for healing.

Source page: https://510kreport.com/device/K962624
Methodology: https://510kreport.com/methodology