BIO-INTERFACES, INC., BIORESORBABLE CALCIUM PHOSPHATE PARTICLES - BII-GRAFT 6140

K960164 · Bio-Interfaces, Inc. · LYC · Apr 10, 1996 · Dental

Device Facts

• Record ID: K960164
• Device Name: BIO-INTERFACES, INC., BIORESORBABLE CALCIUM PHOSPHATE PARTICLES - BII-GRAFT 6140
• Applicant: Bio-Interfaces, Inc.
• Product Code: LYC · Dental
• Decision Date: Apr 10, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic, Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K960164 · Apr 10, 1996	BIO-INTERFACES, INC., BIORESORBABLE CALCIUM PHOSPHATE PARTICLES - BII-GRAFT 6140	Bio-Interfaces, Inc.	Published clinical literature; Professional forums; Clinical experience/communications with clinicians	The sponsor utilized a review of existing clinical literature and professional clinical experience with similar calcium phosphate biomaterials to establish the safety and efficacy profile of the Bii-GRAFT device.	Literature review; Clinical experience; Bone graft substitute

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Literature review of clinical experience; Literature review / Clinical experience summary; Follow-up/Duration: Many years of clinical usage	Patients with osseous defects (e.g., periodontal lesions)	Not applicable for this study	Safety and efficacy as a synthetic bone graft substitute

Indications for Use

Bii-GRAFT™ Bioresorbable Calcium Phosphate Particulate material is indicated as an endosseous implant material for filling and contouring osseous defects such as periodontal lesions. Such an indication represents a low- or no-load reconstructive or augmentation clinical condition.

Device Story

Bii-GRAFT™ is a synthetic, osteoconductive, bioresorbable calcium phosphate bone graft substitute. Composed of 75% hydroxyapatite (HA) and tricalcium phosphate (TCP), it is supplied as particulate matter (105-250μm). Used by clinicians in surgical settings to fill and contour osseous defects, such as periodontal lesions. Material acts as a scaffold for bone adaptation; supports bone growth in non-load-bearing sites. Clinician places particles in direct contact with bleeding bone to facilitate healing. Benefits include synthetic alternative to allogeneic bone, reducing reliance on donor tissue. Potential complications include migration, extrusion, inflammation, or delayed healing if placement guidelines are not followed.

Clinical Evidence

Bench testing only. Evidence includes in-vitro characterization, trace element analysis, and literature review of clinical experience with similar calcium phosphate biomaterials. No prospective clinical trials provided; efficacy supported by established biocompatibility profile and historical clinical usage of calcium phosphate bone graft substitutes.

Technological Characteristics

Particulate form (105-250μm); 75% HA composition; synthetic calcium phosphate. Meets ASTM F-1185 (Ceramic Hydroxylapatite) and ASTM F-1088 (Tricalcium Phosphate) specifications for chemistry and trace elements. Osteoconductive biomatrix. Sterilization method not specified.

Indications for Use

Indicated for patients requiring filling and contouring of osseous defects, specifically periodontal lesions, in low- or no-load reconstructive or augmentation clinical conditions.

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

• Bii-GRAFT™ 1860
• Osteograf-LD™

Reference Devices

• allogeneic freeze-dried bone

Submission Summary (Full Text)

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K960164

Bio-Interfaces, Inc.
Pre Market Notification

## ATTACHMENT IV

The calcium phosphate materials have a well-established biocompatibility profile, based on many years of clinical experience. The ability of calcium phosphate biomaterials in the size range of Bii-GRAFT™ to support bone adaptation is supported by many years of preclinical studies and clinical usage, demonstrating the attractiveness of such calcium phosphates as an endosseous implant material for filling and contouring osseous defects such as periodontal lesions. Such an indication represents a low- or no-load reconstructive or augmentation clinical condition.

Bio-Interfaces, Inc. has conducted a reasonable search of materials research and clinical experience from available published literature and oral communications and presentations at professional forums, as well as private communications with clinicians, regarding the performance of bioresorbable calcium phosphate bone graft substitute materials. Additionally, in-vitro characteristics have been performed and specifications developed for the Bii-GRAFT™ Bioresorbable Calcium Phosphate Particulate material. A review of available clinical results on similar materials indicate efficacy as a synthetic bone graft substitute material, when used in accordance with the guidelines provided in the Instructions for Use. We have concluded that the Bii-GRAFT™ Bioresorbable Calcium Phosphate Particles are substantially equivalent to the referenced devices and are safe and effective for their stated uses. Extensive literature citations have been included with this application.

Bii-GRAFT™ 6140 Bioresorbable Calcium Particles are substantially equivalent to allogeneic freeze-dried bone, Bii-GRAFT™ 1860, Osteograf-LD™ synthetic materials. The determination of equivalence has also been based on the chemical and physical characteristics of Bii-GRAFT™:

* Bii-GRAFT™ 6140 is an osteoconductive biomatrix that approximates the chemical constituent of natural bone. The physical form of the material is particulate particles in the range of $105 - 250\mu$. The nominal composition is 75 percent HA.

* Bii-GRAFT™ meets or exceeds specifications for trace elements and HA/TCP content (chemistry), as specified in ASTM F-1185 and F-1088, the Standard Specifications of Ceramic Hydroxylapatite and Tricalcium Phosphate for Surgical Implants.

* Trace element analysis of Bii-GRAFT™ indicates that the material is at or below the limits established in ASTM F-1088 and F-1185 for TCP and HA, respectively.

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{1}

Bio-Interfaces, Inc.
Pre Market Notification

# ATTACHMENT IV

* That sterilization or re-sterilization using the methods and cycles indicated have no significant effect on the material.

A reasonable attempt has been made to anticipate adverse safety and effectiveness conditions for the submitted device. Like any other implant, this type of bone graft substitute is susceptible to potential clinical problems, but it is believed that they are secondary to the response to the material itself. It is felt that some complications are a result of a failure to heed stated contraindications and practices dictated in the Instructions for Use. Such problems as migration, extrusion, dehiscence, sloughing, delayed healing, paresthesia, edema, hematoma, latent infection, inflammation and local and/or generalized allergic reactions can occur. Conditions such as wound breakdown and dehiscence many times can be traced to clinical placement errors, such as overfilling or failure to properly contain the particulate material after placement. Major load-bearing defects should not be filled with particulate grafting material and it is also important to place the particles in direct contact with bleeding bone. Care needs to be exercised in the use of the material to avoid surgical-related complications.

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