OSTEOSCAF

K101827 · Texas Innovative Medical Devices (Dba) Skeletal · LYC · Apr 20, 2011 · Dental

Device Facts

• Record ID: K101827
• Device Name: OSTEOSCAF
• Applicant: Texas Innovative Medical Devices (Dba) Skeletal
• Product Code: LYC · Dental
• Decision Date: Apr 20, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

OsteosScaf™ bone grafting material is indicated for filling and/or augmenting intraoral/maxillofacial osseous defects, such as intrabony periodontal osseous defects, furcation defects, augmentation of bony defects of the alveolar ridge, filling of tooth extraction sites, and sinus elevation grafting.

Device Story

OsteoScaf™ is a synthetic, osteoconductive, bioresorbable bone grafting material used in dental and maxillofacial surgery. Composed of a 3-phase composite (PLGA, calcium phosphate, and hydroxyapatite), it is provided as particulates, cylinders, or blocks. The device is implanted by a clinician into osseous defects to serve as a scaffold. Its trabecular structure mimics human cancellous bone, facilitating osteoconduction; as the material undergoes hydrolytic and cell-mediated degradation, it is replaced by native bone tissue. The device provides dimensional integrity during handling and placement. It benefits patients by promoting bone regeneration in surgical sites, such as extraction sockets or sinus elevations, aiding in the restoration of bony architecture.

Clinical Evidence

No human clinical data. Evidence consists of bench testing and animal studies. Bench testing verified chemical composition, impurity levels (ASTM 1185), density, porosity (>80%), particle size, morphology, and mechanical strength. Animal studies (rat calvaria model) demonstrated that OsteoScaf™ is osteoconductive and bioresorbable, showing increased new bone formation compared to coagulum control and faster resorption/bone replacement compared to predicate devices.

Technological Characteristics

3-phase composite scaffold: 22% PLGA, 66% calcium phosphates, 12% hydroxyapatite. Highly interconnected macroporous structure (0.25-1.2 mm pore size, >80% porosity). Form factors: particulate, cylinder, block. Sterilization: irradiation. Complies with ASTM 1185 for impurities.

Indications for Use

Indicated for filling and/or augmenting intraoral/maxillofacial osseous defects in patients requiring bone grafting for periodontal defects, furcation defects, alveolar ridge augmentation, tooth extraction sites, and sinus elevation.

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

• ReOSS™ (K082419)
• Bio-OSS™ (K033815)
• Norian PDC™ (K983104)
• Vitoss™ (K083033)

Reference Devices

• HEALOS™

Submission Summary (Full Text)

{0}------------------------------------------------

K101827

K081432

## Section 5

APR 2 0 2011

# 510(k) Summary

| Applicant Name<br>and Address | Texas Innovative Medical Devices (DBA)<br>Skeletal Regeneration, Ltd.<br>14785 Omicron Dr<br>Building 100, Suite 101<br>San Antonio, Texas 78245 | |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Contact Person: | Jerry Chang<br>Senior Director of Quality Assurance/Regulatory Affairs<br>[phone] | |
| Date of Summary: | January 18, 2011 (edits made) Original Submission made<br>June 30, 2010 | |
| Name of Device: | OsteoScaf™ | |
| Trade/Proprietary Name: | OsteoScaf™ | |
| Common Name: | Bone Grafting Materials, Synthetic | |
| Establishment Name: | OsteoScaf™ | |
| Establishment Number: | 21 CFR 872.3930 | |
| Proposed Classification: | Class II | |
| Product Code: | LYC | |
| Panel: | Dental | |
| Predicate Devices: | | |
| ReOSS™ | Intra-Lock International, Inc | K082419 |
| Bio-OSS™ | Geistlich Biomaterials, Inc | K033815 |
| Norian PDC™ | Norian Corp | K983104 |
| Vitoss™ | Orthovita, Inc | K083033 |

Depuy Spine, Inc

HEALOS™

{1}------------------------------------------------

#### Intended Use:

OsteosScaf™ bone grafting material is indicated for filling and/or augmenting intraoral/maxillofacial osseous defects, such as intrabony periodontal osseous defects, furcation defects, augmentation of bony defects of the alveolar ridge, filling of tooth extraction sites, and sinus elevation grafting.

#### Device Description:

OsteoScaf™ is a synthetic osteoconductive and bioresorbable bone grafting material composed of 3-phase biodegradable polymer and calcium phosphate composite, intended to fill and/or augment intraoral/maxillofacial osseous defects. It functions in the same manner as the predicate devices. The product is available as a particulate, cylinder, or block and is provided in sterile packaging in various dosage volumes.

#### Summary of Technological Characteristics:

The OsteoScaf™ bone grafting material is comprised of a 3-phase composite scaffold comprising poly (lactide-co-glycolide) (PLGA) and 2 osteoclast-resorbable calcium phosphate (CaP) phases that provide the same physical characteristics as the listed predicate devices. The latter are particulates synthesized at physiological temperature and blended with the PLGA phase, and a thin layer of hydroxyapatite surface coating generated in a simulated body fluid at physiological temperature. The Device is configured as a particulate, cvlinder or in a block shape and is packaged in a tray and a chevron type peel pouch for easy use. The product is irradiated to ensure sterility. The Device has a trabecular structure that is the same as the predicate devices and mimics the multidirectional interconnected porosity of human cancellous bone. The Device resorbs and is replaced with natural bone, which remodels during the healing process in the same fashion as that of the predicate devices.

#### Summary of Performance Testing:

Bench and animal studies were conducted to ensure that OsteoScaf™ bone grafting material met the predetermined design specifications. OsteoScaf™ has been tested for a number of chemical and physical characteristics: chemical composition, phase composition, trace of impurities, density and porosity, particle size, morphology, compressive strength and elastic modulus. All these characteristics are equivalent to those of the predicate device. OsteoScaf™ is osteoconductive and bioresorbable based on in vivo studies. When OsteoScaf™ is placed in direct contact with viable bone, new bone forms in apposition to the OsteoScaf™ surfaces and within the interstices of the implant. As the material resorbs, bone tissue grows into the space previously occupied by the implant. The testing performed included the following:

{2}------------------------------------------------

| Test Items | Summarized Results |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Chemical composition | 3-phase composite of 22% (wt) PLGA, 66% Calcium phosphates<br>and 12% hydroxyapatite. |
| Impurity | Testing demonstrates compliance with ASTM 1185 requirements. |
| Pore structure | Highly interconnected macroporous structure of larger than 80%<br>porosity and 0.25~1.2 mm pore size similar to human cancellous<br>bone. |
| Mechanical strength | The devices provides adequate handling properties and strength to<br>ensure dimensional integrity when handled by the surgeon and<br>delivered to bony application sites. |
| Degradation | All three phases of the composite can be resorbed over time through<br>hydrolytic and/or cell-mediated degradation. |
| Animal studies | 1) OsteoScaf™ was used to reconstruct the critical-sized defect in a<br>rat calveria model. The result demonstrated that more new bone<br>formed with OsteoScaf™, compared to coagulum control, after 4<br>weeks.<br>2) OsteoScaf™ gave rise to more new bone formation and faster<br>resorption of the material than the predicate in a rat model.<br>3) The biomechanical testing in rat model demonstrates that<br>OsteoScaf™<br>bone grafting material facilitates replacement with<br>native bone. |

#### Conclusion:

The Company Device (OsteoScaf™) is substantially equivalent to the predicate devices for filling and/or augmenting intraoral/maxillofacial osseous defects, such as intrabony periodontal osseous defects, furcation defects, augmentation of bony defects of the alveolar ridge, filling of tooth extraction sites, and sinus elevation grafting. The Device is also substantially equivalent to the predicate devices in terms of material composition, geometry, and technological characteristics. The material is at least as safe and effective as predicate devices.

{3}------------------------------------------------

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Jerry Chang Senior Director of Quality Assurance and Regulatory Affairs Texas Innovative Medical Devices (DBA) Skeletal 4808 Research Drive San Antonio, Texas 78240

Re: K101827

Trade/Device Name: OsteoScafTM Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: March 31, 2011 Received: April 1, 2011

APR 2 0 2011

Dear Mr. Chang:

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 mav, 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.

{4}------------------------------------------------

Page 2- Mr. Chang

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 reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

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/ucm 115809.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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Nh 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

#### Enclosure

{5}------------------------------------------------

## Section 4 Indications for Use

510(k) Number (if known): K101827

Device Name: OsteoScaf™

Indications for Use:

OsteoScaf™ bone grafting material is indicated for filling and/or augmenting intraoral/maxillofacial osseous defects, such as intrabony periodontal osseous defects, furcation defects, augmentation of bony defects of the alveolar ridge, filling of tooth extraction sites, and sinus elevation grafting.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use __ (21 CFR 801 Subpart C)

### · (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

K. Alberons for Dr. Susan Runner
Division Sign-Off

ivision Sign-K

Office of Device Evaluation (ODE)

510(k) K101827

Page 1 of 1