NOVABONE DENTAL MORSELS - BIOACTIVE SYNTHETIC BONE GRAFT
Device Facts
| Record ID | K112428 |
|---|---|
| Device Name | NOVABONE DENTAL MORSELS - BIOACTIVE SYNTHETIC BONE GRAFT |
| Applicant | Novabone Products, LLC |
| Product Code | LYC · Dental |
| Decision Date | Dec 16, 2011 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3930 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The intended use of NovaBone Dental Morsels is to provide a safe, biocompatible synthetic bone graft material for use in oral, dental intraosseous, and maxillofacial bone defects. It is used in a manner comparable to autogenous bone graft chips or allograft bone particulate (Demineralized Freeze Dried Bone). Typical uses include: periodontal / infrabony defects; ridge augmentation (sinusotomy, osteotomy, cystectomy); extraction sites (ridge maintenance/augmentation, implant preparation/ placement); sinus lifts; cystic cavities; oral and maxillofacial augmentation.
Device Story
NovaBone Dental Morsels is a synthetic, bioactive, osteoconductive bone void filler. Input: device is packed into dental/maxillofacial bony defects by a clinician. Principle: calcium phospho-silicate (Bioglass) particles undergo ion exchange to form a calcium phosphate surface layer, acting as a scaffold for new bone infiltration. Output: device is progressively resorbed and replaced by host bone. Used in dental/oral surgery settings. Benefits: provides non-structural scaffold for natural bone regeneration; biocompatible; resorbable.
Clinical Evidence
Bench testing only. Evidence includes compositional analysis, in vivo bone void testing demonstrating new bone formation at early post-implantation periods, and ISO 10993 biocompatibility testing. No clinical data provided.
Technological Characteristics
Material: Inorganic calcium phospho-silicate (Bioglass) fused into porous form. Porosity: 40-60% volume, 50-400 micron pore size. Particle size: 500-2000 microns. Sterilization: Gamma irradiation (SAL 10-6). Form factor: Particulate graft material in PET-G tray.
Indications for Use
Indicated for patients requiring bone grafting in oral, dental intraosseous, and maxillofacial defects. Used for periodontal/infrabony defects, ridge augmentation, extraction sites, sinus lifts, and cystic cavities.
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
- PerioGlas - Bone Graft Particulate (K053387, K040278, K992416, K962494, K930115)
- NovaBone Porous - Bone Graft Scaffold (K060432, K090731)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logo for NOVABONE. The logo is in black and features the company name in a bold, sans-serif font. Below the company name is the tagline "DRIVING INNOVATION IN OSTEOBIOLOGICS" in a smaller font.
K112428
DEC 1 6 2011
### 08/19/11 510(k) Summary NovaBone Dental Morsels - Bioactive Synthetic Bone Graft
#### Submitter Information: 1.
| Name: | NovaBone Products, LLC |
|------------|----------------------------------------------------------|
| Address: | 13631 Progress Boulevard, Suite 600<br>Alachua, FL 32615 |
| Telephone: | (386) 462-7661 |
| Facsimile: | (386) 418-1636 |
| Contact: | David M. Gaisser |
#### Name of Device: 2.
| Trade Name: | NovaBone Dental Morsels – Bioactive Synthetic Bone Graft |
|--------------------|------------------------------------------------------------------------------|
| Common Name: | Osteoconductive Bone Void Filler<br>Synthetic Resorbable Bone Graft Material |
| Regulation Number: | 21 CFR 872.3930 |
| Regulation Name: | Bone Grafting Material, Synthetic |
| Regulatory Class: | Class II |
| Product Code: | LYC |
#### Legally Marketed Predicate Device: 3.
| Predicate #1: | PerioGlas - Bone Graft Particulate<br>[K053387, K040278, K992416, K962494, K930115] |
|---------------|-------------------------------------------------------------------------------------|
| Predicate #2: | NovaBone Porous – Bone Graft Scaffold<br>[K060432, K090731] |
#### Device Description 4.
NovaBone Dental Morsels is an osteoconductive, bioactive, bone void filler device. The device is intended for dental intraosseous, oral, and maxillofacial bony defects. It is a one-component, resorbable bone void filler composed of a synthetic calcium phospho-silicate (Bioglass) particulate, fused into a bulk porous form having a multidirectional interconnected porosity. The device is supplied sterile, packaged in a disposable PET-G tray with heat-sealed lid. On implantation, NovaBone Dental Morsels undergoes a time-dependent surface modification, resulting in the formation of a calcium phosphate layer on the device surfaces. The device acts as a scaffold, with new bone infiltrating the porous structure. NovaBone Dental Morsels is progressively resorbed and replaced by new bone tissue during the healing process.
#### Indications for Use ട.
The intended use of NovaBone Dental Morsels is to provide a safe, biocompatible synthetic bone graft material for use in oral, dental intraosseous, and maxillofacial bone defects. It is used in a manner comparable to autogenous bone graft chips or allograft bone particulate (Demineralized Freeze Dried Bone). Typical uses include: periodontal / infrabony defects; ridge augmentation (sinusotomy,
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osteotomy, cystectomy); extraction sites (ridge maintenance/augmentation, implant preparation/ placement); sinus lifts; cystic cavities; oral and maxillofacial augmentation.
#### Technological Characteristics and Substantial Equivalence 6.
The technological characteristics of the NovaBone Dental Morsels device are similar to the predicate devices. A side-by-side comparison of the devices is given in Table 3.1. The new device and the predicates are designed as osteoconductive space-filling devices that aid in the bone repair process. The device indications are unchanged from those of the PerioGlas predicate device. The device is intended to be used alone, or in combination with autogenous or allograft bone.
The technological characteristics of the NovaBone Dental Morsels are similar to those of the predicates in terms of the device material. All three devices are a single-phase, calcium phospho-silicate material. Physically, the Dental Morsels device has an open pore structure identical to the NovaBone Porous predicate. The Dental Morsels particle size is between that of the PerioGlas predicate and the larger orthopedic NovaBone Morsels device.
NovaBone Dental Morsels and the predicates are designed to be gently packed into defect sites, functioning as a non-structural scaffold for the body's natural healing and bone regeneration process. The Dental Morsels and the PerioGlas predicate are indicated for oral and dental indications while NovaBone Porous is intended for orthopedic bone defects. The device acts as a synthetic, inorganic, biocompatible and osteoconductive scaffold into which new bone will grow.
Information provided in this submission includes compositional analysis, in vivo bone void testing, and ISO 10993 biocompatibility results. Test results indicate that this material is biocompatible and safe for its intended use.
#### 7. Conclusion
The NovaBone Dental Morsels device serves as a bone void filler for nonstructural osseous defects for dental intraosseous, oral, and maxillofacial indications. The device physical structure is modified from the PerioGlas predicate to provide a device with interconnected porosity for tissue ingrowth. This device modification does not result in a change in technological characteristics of the device. In vivo study data were presented supporting the osteoconductive nature of the device demonstrating new bone formation at early post-implantation periods, with no evidence of local or systemic adverse effects related to the device observed. Additional supporting in vitro data were supplied.
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| Substantial | New Device | Predicate #1 | Predicate #2 |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Equivalence<br>Comparison | NovaBone Dental Morsels | PerioGlas<br>[K040278, K992416,<br>K962494, K930115] | NovaBone Porous<br>[K060432, K090731] |
| Intended Use | A non-structural<br>osteoconductive bone void<br>filler for osseous defects. | Same as new device | Same as new device |
| Indications | To fill and/or augment oral,<br>dental intraosseous, and<br>maxillofacial bone defects<br><br>Classif. Code: LYC | Same as new device<br><br>Classif. Code: LYC | Orthopedic bony voids<br>in gaps of the skeletal<br>system (i.e., the<br>extremities and pelvis)<br><br>Classif. Code: MQV |
| Application | Gently packed into defect sites<br>as a non-structural scaffold for<br>the body's natural healing and<br>bone regeneration processes. | Same as new device | Same as new device |
| Material | Inorganic calcium phospho-<br>silicate, thermally formed and<br>bound together in a sodium<br>silicate network.<br>Individual particles fused to<br>form porous graft material | Same material as new<br>device, but the individual<br>particles are not fused<br>together to create a<br>porous material. | Same as new device |
| Device Porosity | Interconnected pore structure,<br>with 40-60% pore volume and<br>50-400 micron pore size, | Dense individual<br>particles. Space between<br>packed particles provides<br>approx 50% pore volume | Same as new device |
| Particle Sizes | 500 - 1000 microns<br>and<br>1000 - 2000 microns | 90 - 710 microns<br><br>Smaller than new device | 2000 - 5000 microns<br><br>Larger than new device |
| Device Action | Ion diffusion and exchange at<br>particle surfaces form a calcium<br>phosphate surface layer, which<br>acts as a scaffold for new bone<br>formation throughout the graft<br>site via osteoconduction.<br>Continued ion diffusion and<br>exchange results in material<br>resorption. | Same as new device | Same as new device |
| Performance | Bone infiltration occurs<br>throughout the graft site via<br>osteoconduction, resulting in<br>increased graft site mechanical<br>stiffness and strength | Same as new device | Same as new device. |
| Substantial<br>Equivalence<br>Comparison | New Device<br>NovaBone Dental Morsels | Predicate #1<br>PerioGlas<br>[K040278, K992416,<br>K962494, K930115] | Predicate #2<br>NovaBone Porous<br>[K060432, K090731] |
| Bone remodeling | New bone grows into the graft<br>area via osteconduction. The<br>material is slowly absorbed<br>and replaced by the host bone. | Same as new device | Same as new device. |
| Resorption Rate | Majority absorbed by six<br>months | Same as new device | Same as new device |
| Biocompatibility | Biocompatible, non-antigenic;<br>full ISO 10993 testing | Same as new device | Same as new device |
| Mechanical | Particulate material; not<br>intended for use in load-<br>bearing defects without proper<br>internal or external fixation | Same as new device | Same as new device |
| Package Format | PETG cups with Tyvek® lids | PETG cup / Tyvek lid<br>and<br>PP syringe in foil pouch | PETG cup / Tyvek lid<br>and<br>PP syringe in foil pouch |
| Sterility | Gamma Irradiation<br><br>SAL 10-6 | EO Gas (cups/lids);<br>and<br>Gamma (syringe)<br><br>both SAL 10-6 | EO Gas (cups/lids)<br>and<br>Gamma (syringe)<br><br>both SAL 10-6 |
# Table 3.1 Comparison of the New Device to the Marketed Predicate Devices
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# Table 3.1 Comparison of the New Device to the Marketed Predicate Devices
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### DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings, rendered in a simple, bold line drawing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. David M. Gaisser Vice President -- Operations/RA/OA NovaBone Products, LLC 13631 Progress Boulevard. Suite 600 Alachua, Florida 32615
DEC 1 6 2011
Re: K112428
Trade/Device Name: NovaBone Dental Morsels - Bioactive Synthetic Bone Graft Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: November 29, 2011 Received: December 15, 2011
Dear Mr. Gaisser:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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## Page 2 - Mr. Gaisser
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reportung (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
hr for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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# STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known):
NovaBone Dental Morsels - Bioactive Synthetic Bone Graft Device Name:
Indications For Use:
The intended use of NovaBone Dental Morsels is to provide a safe, biocompatible synthetic bone graft material for use in oral, dental intraosseous, and maxillofacial bone defects. It is used in a manner comparable to autogenous bone graft chips or allograft bone particulate (Demineralized Freeze Dried Bone). Typical uses include:
- · Periodontal / infrabony defects
- · Ridge augmentation (sinusotomy, osteotomy, cystectomy)
- (ridge maintenance/augmentation, sites implant preparation/ · Extraction placement)
- · Sinus lifts
- · Cystic cavities
- · Oral and maxillofacial augmentation
Prescription Use XX
OR (Per 21 CFR 801.109) Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Clee
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K112428
