# K013346: Gore Drapeable ST/LT Regenerative Membrane

- Pathway: 510(k) (Traditional)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: Dec 19, 2001 after 71 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.
144 later devices descend from it; 2 cite it directly.
0 of 145 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 XT Regenerative Membrane: named in the summary without a submission number
- (no number) GORE OSSEOQUEST Regenerative Membranes: named in the summary without a submission number

## Most influential descendants
- K030782: Seamguard Bioabsorbable Staple Line Reinforcement Material (2003), 143 descendants of its own
- K032865: Gore Seamguard Bioabsorbable Staple Line Reinforcement Material (2003), 102 descendants of its own
- K043056: Gore Seamguard Bioabsorbable Staple Line Reinforcement Material (2004), 77 descendants of its own
- K040119: Peri-Strips Staple Line Reinforcement-Sleeve Configuration, Peri-Strips Staple Line Reinforcement-Strip Configuration (2004), 69 descendants of its own
- K080898: Auto Suture Endo Gia Staplers with Endo Gia Single Use Loading Units with Staple Line Reinforcement (2008), 48 descendants of its own

## Indications for use
GORE DRAPEABLE ST and LT Regenerative Membranes are bioabsorbable, implantable materials intended to aid in the healing of periodontal and bone defects. They may also be used as a membrane for bone graft containment. When used over a bone graft, GORE DRAPEABLE ST and LT Regenerative Membranes provide a stable barrier to prevent migration of bone graft material and provides a favorable environment for bone regeneration. When used in the treatment of non-spacemaking defects, GORE DRAPEABLE ST and LT Regenerative Membranes may be used in combination with spacemaking bone graft materials (e.g., autogenous bone, bone substitutes).

Source page: https://510kreport.com/device/K013346
Methodology: https://510kreport.com/methodology