PERIOGLAS PUTTY-BIOACTIVE BONE GRAFT GEL

K063596 · Novabone Products, LLC · LYC · Feb 22, 2007 · Dental

Device Facts

• Record ID: K063596
• Device Name: PERIOGLAS PUTTY-BIOACTIVE BONE GRAFT GEL
• Applicant: Novabone Products, LLC
• Product Code: LYC · Dental
• Decision Date: Feb 22, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of PerioGlas Putty is to provide a safe, biocompatible synthetic bone graft material for use in oral, dental intraosseous, and craniofacial defects. It is used alone in a manner comparable to autogenous bone graft chips or allograft bone particulate (Demineralized Freeze Dried Bone) or may be mixed with either (typically 1:1 ratio v/v) as a bone graft extender. Typical uses include: - Periodontal/Infrabony defects - Ridge Augmentation (sinusotomy, osteotomy, cystectomy) - Extraction sites maintenance/augmentation, implant (ridge preparation/ placement) - Sinus lifts - Cystic cavities - Cranio-facial augmentation. For larger defects, a mixture of PerioGlas Putty with an equal volume of allograft or autograft bone and bone marrow may improve new bone formation.

Device Story

PerioGlas Putty is a synthetic, osteoconductive bone void filler; composed of bioactive glass (45S5 Bioglass) particulate and a gelatin binder. Supplied sterile; intended for dental/craniofacial surgical use by clinicians. Gelatin binder provides malleability for placement; hydrates when wetted; rapidly absorbed post-implantation to allow cell infiltration. Bioglass particles remain as a scaffold for host bone ingrowth; gradually resorbed and replaced by new bone tissue. Used alone or as an extender with autograft/allograft. Not for load-bearing applications; requires internal/external stabilization for fracture fixation. Benefits include biocompatible scaffold for natural bone regeneration.

Clinical Evidence

In vivo performance data and supporting in vitro data were presented to demonstrate substantial equivalence. No specific clinical trial metrics (e.g., p-values, sensitivity) were detailed in the summary; the device relies on the established safety and efficacy profile of the predicate bioactive glass materials.

Technological Characteristics

Osteoconductive bone void filler; two-component system: 45S5 Bioglass (calcium-phosphorus-sodium-silicate) particulate and gelatin binder. Malleable putty form factor when wetted. Non-structural scaffold; resorbable. Sterilized. No software or electronic components.

Indications for Use

Indicated for patients requiring bone void filling or augmentation in oral, dental intraosseous, and craniofacial defects, including periodontal/infrabony defects, ridge augmentation, extraction sites, sinus lifts, and cystic cavities. Contraindicated in individuals with known allergies to gelatin.

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 - Synthetic Bone Graft Particulate (K053387, K040278, K992416, K962492, K930115)
• NovaBone Putty - Resorbable Bone Void Filler (K051617)

Submission Summary (Full Text)

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2007

Image /page/0/Picture/1 description: The image shows the words "510(k) Summary" on the left side of the image. On the right side of the image, the words "NOVABONE SYNTHETIC BONE GRAFT PRODUCTS" are stacked on top of each other. Below that, the number "K063596" is written in cursive with a line underneath it.

11/30/06

#### Submitter Information: 1.

PerioGlas Putty - Bioactive Bone Graft Gel

| Name: | NovaBone Products, LLC |
|------------|----------------------------------------------------|
| Address: | 13709 Progress Boulevard, #33<br>Alachua, FL 32615 |
| Telephone: | [phone] |
| Facsimile: | [phone] |
| Contact: | David M. Gaisser |

#### 2. Name of Device:

| Trade Name: | PerioGlas Putty -- Bioactive Bone Graft Gel |
|----------------------|------------------------------------------------------------------------------|
| Common Name: | Osteoconductive Bone Void Filler<br>Synthetic Resorbable Bone Graft Material |
| Classification Name: | Endosseous Implant for Bone Filling and/or Augmentation |

#### 3. Legally Marketed Predicate Device:

| Predicate #1: | PerioGlas -- Synthetic Bone Graft Particulate<br>[K053387, K040278, K992416, K962492, K930115]<br>(Also named as NovaBone per Special 510(k) K000149) |
|---------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate #2: | NovaBone Putty - Resorbable Bone Void Filler<br>[K051617] |

#### 4. Device Description

PerioGlas Putty is an osteoconductive, bioactive, bone void filler device. The device is intended for dental intraosseous, oral, and cranio-/maxillofacial bony defects and is supplied sterile. PerioGlas Putty is a two-component device composed of a synthetic bioactive glass particulate mixed with a binder. The a melt-derived calcium-phosphorus-sodium-silicate major component is designed specifically for for its absorbability (Bioglass) particulate and osteoconductive nature. The second component is gelatin powder, selected for its biocompatibility and physical gelation properties to act as a temporary binding agent for the particulate. The gelatin is rapidly absorbed from the graft site to permit tissue infiltration between the Bioglass particles and replacement of the particles by host bone during the healing process.

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510(k) Premarket Notification NovaBone Products, LLC NovaBone Putty - Resorbable Bone Void Filler Confidential

K063596
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#### 5. Intended Use

PerioGlas Putty is indicated to be packed into bony voids or gaps to fill and/or augment oral, dental intraosseous, and craniofacial defects. These defects may include: periodontal/infrabony defects; alveolar ridge augmentation (sinusotomy. osteotomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; craniofacial augmentation. PerioGlas Putty may be used alone in a manner comparable to autogenous bone graft chips or allograft bone particulate (demineralized freeze dried bone), or it may be mixed with either as a bone graft extender.

#### 6. Technological Characteristics

The technological characteristics of the PerioGlas Putty device are similar to those of the predicates. The device and the predicates are designed as osteoconductive space-filling devices to be gently packed into defect sites and used as nonstructural scaffolds for the body's natural healing and bone regeneration process. The device indications are the same as for the PerioGlas predicate.

The PerioGlas Putty device is identical in composition and formulation to the NovaBone Putty predicate device. The primary component of PerioGlas Putty is identical to the bioactive glass (45S5 Bioglass) particulate found in the PerioGlas and NovaBone Putty predicates. This synthetic material is both biocompatible and osteoconductive. The main technological difference between PerioGlas Putty and the PerioGlas predicate device is that while PerioGlas contains only the particulate bioactive glass component, the PerioGlas Putty contains a second component (gelatin) that acts as a temporary binding agent between the particles when wetted with water. When wetted, this gelatin binder hydrates and fills the space between the Bioglass particles, resulting in a soft malleable putty to aid product handling and placement. The gelatin binder then is rapidly removed from the implantation site via normal physiologic processes, opening space between the bioactive glass particles for cell infiltration and bone formation.

After binder absorption, the residual Bioglass particles of the PerioGlas Putty device remain in the graft site. This particulate acts as a scaffold for bone ingrowth, with gradual absorption and replacement by new bone tissue. The PerioGlas Putty and predicate devices are substantially absorbed within the sixmonth timeframe normally associated with bone remodeling, the devices being replaced by new bone tissue.

#### 7. Warnings and Precautions

PerioGlas Putty does not possess sufficient mechanical strength to support loadbearing defects prior to hard tissue ingrowth. In cases of fracture fixation or

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Confidential
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where load support is required, standard internal or external stabilization techniques must be followed to obtain rigid stabilization in all planes.

PerioGlas Putty is intended for use by clinician familiar with bone grafting and internal/external fixation techniques. PerioGlas Putty must not be used to gain screw purchase or to stabilize screw placement.

PerioGlas Putty contains gelatin. This device should not be used by individuals having known allergies to gelatin products.

#### 8. Complications

Possible complications are the same as to be expected of autogenous bone grafting procedures. These may include: superficial wound infection, deep wound infection, deep wound infection with osteomyelitis, delayed union, loss of reduction, failure of fusion, loss of bone graft, graft protrusion and / or dislodgement, and general complications that may arise from anesthesia and / or surgery. Complications specific to oral/dental use are those as may be typically observed for similar bone grafting procedures and may include: tooth sensitivity, gingival recession, flap sloughing, resorption or ankylosis of the treated root, abscess formation.

The potential for allergic reaction to the gelatin component exists.

#### 9. Conclusion

PerioGlas Putty is claimed to be substantially equivalent to the PerioGlas and NovaBone Putty predicate devices as a non-structural osteoconductive bone void filler for osseous defects. In vivo performance data were presented. Additional supporting in vitro data were supplied.

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Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### FEB 2 2 2007

Mr. David M. Gaisser Vice President NovaBone Products, LLC 13709 Progress Boulevard, #33 Alachua, Florida 32615

Re: K063596

Trade/Device Name: PerioGlas Putty -Bioactive Bone Graft Gel Regulation Number: 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: November 30, 2006 Received: December 6, 2006

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Oves
Chiu-Lin Liu, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Confidential

510(k) Premarket Notification NovaBone Products, LLC PerioGlas Putty - Bioactive Bone Graft Gel

Graft Gel

K063596

# STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known):

Device Name: __PerioGlas Putty - Bioactive Bone Graft Gel

Indications For Use:

The intended use of PerioGlas Putty is to provide a safe, biocompatible synthetic bone graft material for use in oral, dental intraosseous, and craniofacial defects. It is used alone in a manner comparable to autogenous bone graft chips or allograft bone particulate (Demineralized Freeze Dried Bone) or may be mixed with either (typically 1:1 ratio v/v) as a bone graft extender. Typical uses include:

- Periodontal/Infrabony defects
- · Ridge Augmentation (sinusotomy, osteotomy, cystectomy)
- · Extraction sites maintenance/augmentation, implant (ridge preparation/ placement)
- Sinus lifts
- · Cystic cavities
- · Cranio-facial augmentation

For larger defects, a mixture of PerioGlas Putty with an equal volume of allograft or autograft bone and bone marrow may improve new bone formation.

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)

Qur

Division of Anesthesiology, Memorial Hospital,
Infection Control, Dental Devices

K.0.63576