RESOLUT REGENERATIVE MATERIAL

K970884 · W. L. Gore & Associates, Inc. · LYC · May 8, 1997 · Dental

Device Facts

• Record ID: K970884
• Device Name: RESOLUT REGENERATIVE MATERIAL
• Applicant: W. L. Gore & Associates, Inc.
• Product Code: LYC · Dental
• Decision Date: May 8, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 bone regeneration.

Device Story

RESOLUT Regenerative Material is a bioabsorbable implant used in oral surgery to facilitate guided tissue regeneration (GTR). The device consists of a porous glycolide polymer fiber structure and an occlusive glycolide/lactide copolymer membrane. Surgically placed beneath the muco-periosteum by a clinician, the device acts as a physical barrier to inhibit epithelial migration and contain bone graft materials. By isolating the periodontal defect from gingival connective tissue, it creates a stable, cell-occlusive space that promotes bone and periodontal ligament regeneration. The material is designed to be biocompatible and clinically manageable, eventually resorbing as the wound heals. It serves as an alternative to non-resorbable membranes or metal meshes, reducing the need for secondary removal procedures.

Clinical Evidence

Evidence includes a preclinical canine mandibular defect study and two clinical studies. The first clinical study compared resorbable and non-resorbable membranes, showing bone regeneration in membrane-treated sites. The second clinical study, using autogenous bone grafts for space maintenance, demonstrated a highly significant reduction in defect size (p < 0.001) with an average bone fill of 93%.

Technological Characteristics

Composed of synthetic bioabsorbable glycolide polymer fiber (porous structure) and synthetic bioabsorbable glycolide and lactide copolymer (occlusive membrane). Designed for biocompatibility, cell occlusion, and space-making. Implantable, resorbable material.

Indications for Use

Indicated for patients requiring regenerative healing of bone or periodontal ligament defects in the oral cavity, including use as a barrier membrane for bone graft containment.

Regulatory Classification

Identification

Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.

Special Controls

*Classification.* (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

• RESOLUT Regenerative Material (K970884)
• CAPSET Calcium Sulfate Bone Graft Barrier
• Micro Titanium Augmentation Mesh

Submission Summary (Full Text)

{0}

K970884

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

MAY - 8 1997

1. **Applicant Name, Address:** W.L. Gore &amp; Associates, Inc.
1500 North Fourth Street
P.O. Box 2500
Flagstaff, AZ 86003-2500

**Contact Person, Telephone:** John W. Nicholson
(520) 779 - 2771

**Date of Summary:** March 6, 1997

2. **Classification Name:** Resorbable Barrier Membrane
**Common or Usual Name:** Regenerative Material
**Proprietary Name:** RESOLUT Regenerative Material

3. **Predicate Device** RESOLUT Regenerative Material, CAPSET
Calcium Sulfate Bone Graft Barrier, and Micro Titanium Augmentation Mesh.

4. **Device Description:**
RESOLUT Regenerative Material is composed of a porous structure of synthetic bioabsorbable glycolide polymer fiber and an occlusive membrane of synthetic bioabsorbable glycolide and lactide copolymer. The porous structure is designed to attach to surrounding soft tissue and inhibit epithelial migration, while the occlusive membrane isolates the periodontal defect from gingival connective tissue during wound healing. RESOLUT Regenerative Material has been designed to act in accordance with the accepted principles of wound healing and guided tissue regeneration (GTR). Specifically, the device is designed to be biocompatible, cell occlusive, spacemaking, and clinically manageable, and allow for tissue integration.

RESOLUT BONE GRAFT

{1}

RESOLUT Regenerative Material is surgically placed beneath the muco-periosteum to aid in the regenerative healing of bone/periodontal ligament defects of the oral cavity or, when placed over bone graft material, to prevent graft material migration.

## 5. Intended 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 bone regeneration.

## 6. Technological Characteristics:

RESOLUT Regenerative Material has been designed to act in accordance with the accepted principles of wound healing and guided tissue regeneration (GTR). Specifically, the device is designed to be biocompatible, cell occlusive, spacemaking, and clinically manageable, and allow for tissue integration.

## 7. Assessment of Performance Data:

A preclinical study in canine mandibular defects demonstrates that RESOLUT Regenerative Material can be used as a membrane to contain bone grafting materials. Like CAPSET Calcium Sulfate Bone Graft Barrier, it has been shown to provide a favorable environment for bone regeneration.

In the first clinical study, the investigators used a comparative histological study to evaluate the regenerative capabilities of both resorbable and non-resorbable barrier membranes in defects associated with endosseous implant placement. Additionally, they included untreated controls (i.e., no barrier membrane) in this study. They found that there was bone regeneration in the membrane-treated sites, but there was more in the defects treated with the non-resorbable barrier

RESOLUT BONE GRAFT
- 65 -

{2}

membrane. However, they concluded that “to achieve complete regeneration, it may be necessary to use resorbable membranes in association with osteoconductive/osteoinductive space maintaining material, such as autogenous grafts”. The importance of the first clinical study is that it provides histological evidence of bone regeneration.

The second clinical study tests their hypothesis further and utilized autogenous bone grafts to maintain an adequate space under the barrier membranes. The overall study results showed a highly significant reduction in defect (p &lt; 0.001), with an average bone fill per defect of 93%. This study provides confirmatory evidence that barrier membranes, when used as membranes for bone graft containment, provides a favorable environment for bone regeneration.

## 8. Conclusion:

There have been no changes to RESOLUT Regenerative Material in terms of its design, manufacturing process, materials, and intended use. The modifications to the indications for use are substantially equivalent to the indications for use of CAPSET Calcium Sulfate Barrier Graft, Micro Titanium Augmentation Mesh, and the predicate RESOLUT Regenerative Material.

RESOLUT BONE GRAFT