EQUIMATRIX

{0}------------------------------------------------ i. 25 111 #### 510(k) Summary 2.0 K111816 #### Sponsor/Applicant Luitpold Pharmaceuticals, Inc. One Luitpold Drive, PO Box 9001 Shirley, NY 11967 Phone: 610.650.4200 Fax: 610.650.0114 Contact: Marsha E. Simon SEP 2 9 2011 Date Prepared: June 23, 2011 #### Device Name and Identification Proprietary Name: EquiMatrix™ Common/Usual Name: Natural Bone Mineral Matrix Anorganic Equine Bone Grafting Material Classification Name: Bone Grafting Material Animal Source Dental Bone Grafting Material #### Predicate Device Bio-Oss® natural bone grafting material (K871773, K952617, K970321. K033815) Manufactured by: Geistlich Pharma AG Bahnhofstrasse 40 CH-6110 Wolhusen Switzerland ### Device Category/Class Class II Device Class: Regulation Number: 21 C.F.R. 872.3930 Product Code: NPM {1}------------------------------------------------ K111816 ### Intended Use EQUIMATRIX™ cancellous and cortical granules are recommended for: - Augmentation or reconstructive treatment of the alveolar ridge. - - Filling of infrabony periodontal defects. 1 - Filling of defects after root resection, apicoectomy, and cystectomy. - - Filling of extraction sockets to enhance preservation of the alveolar ridge. - - Elevation of the maxillary sinus floor. - - Filling of periodontal defects in conjunction with products intended for - Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR). - Filling of peri-implant defects in conjunction with products intended for ー Guided Bone Regeneration (GBR). ### Device Description EquiMatrix™ is a sterile, natural, non-antigenic, porous bone mineral matrix produced by the removal of organic compounds from equine bone. Due to its natural structure EquiMatrix™ is physically and chemically comparable to the mineralized matrix of human bone. The anorganic bone matrix of EquiMatrix™ has a macro and microporous structure similar to human bone. The formation and in-growth of new bone at the implantation site of EquiMatrix™ is favored due to its trabecular architecture, interconnecting macro and micro pores, and its natural consistency. It is supplied as cancellous (spongiosa) or cortical granules in a single use container, packaged in a secondary thermoform blister, and sterilized by v-irradiation. ### Technological Aspects of Particulate Bone Grafting Particulate bone grafts (cancellous and cortical) are widely used in dentistry for the treatment of periodontal bone defects, prevention of alveolar resorption following tooth extraction, and to augment deficient and atrophic sites prior to implant placement. Although autogenous tissue has been traditionally regarded as the gold standard for bone regeneration, it has the disadvantage of limited availability, increased patient morbidity, and irregular resorptive patterns. Therefore, other sources of graft material including allogenic, alloplastic, and xenogenic particles have been developed and studied as an osteoconductive matrix for new bone formation. Xenoarafts of bovine origin have proven to be especially useful for guided bone regeneration in stabilizing the blot clot, promoting revascularization and maintaining space during wound healing. There is also an inherent advantage in these xenografts for sinus augmentation and in the aesthetic zone as a foundation for implant and dental reconstruction due to the slower resorption rate. {2}------------------------------------------------ K///816 Equimatrix is a particulate natural bone mineral derived from horses which is proposed as an alternative xenograff material for use where dental bone grafting is required for treatment of periodontal defects and implant site development. # Basis for Substantial Equivalence EquiMatrix™ and Bio-Oss® have a similar physical and chemical structure. Both are porous, biocompatible bone grafts that facilitate the formation and mineralization of new bone by the osteoblast. The primary difference between the two products is the source bone: EquiMatrix™ is manufactured from equine (horse) bones, while Bio-Oss® is manufactured from bovine (cows) source material. The following table summarizes the basis for the Sponsor's substantial equivalence determination: | Item | EquiMatrix™ | Bio-Oss® | |----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------| | Intended use | Used as an adjunctive therapy in restoring bony defects | Used as an adjunctive therapy in restoring bony defects | | Target population | Human oral, periodontal | Human oral, periodontal | | Dosage form | Granules contained in single use container | Granules contained in single use container | | Granule sizes | 0.2 mm to 1.0 mm or<br>1.0 mm to 2.0 mm<br>granules | 0.25 mm to 1.0 mm or<br>1.0 mm to 2.0 mm<br>granules | | Material | Anorganic naturally<br>derived osteoconductive<br>hydroxyapatite bone<br>mineral | Anorganic naturally<br>derived osteoconductive<br>hydroxyapatite bone<br>mineral | | Table 1 (continued)<br>Item | EquiMatrix™ | Bio-Oss® | | Source bone | Equine bone | Bovine bone | | Physical Morphology | Trabecular,<br>interconnecting macro<br>and micro pores | Trabecular,<br>interconnecting macro<br>and micro pores | | Biocompatibility | Biocompatible, as<br>demonstrated by:<br>- Genotoxicity<br>testing<br>- Intracutaneous<br>reactivity testing<br>- Maximization and<br>sensitization<br>testing<br>- Pyrogen testing<br>- Acute systemic<br>injection testing<br>- Cytotoxicity<br>testing<br>- Implantation<br>testing<br>- Preclinical safety<br>and efficacy<br>testing<br>- Clinical case<br>series | Biocompatible (as<br>demonstrated in<br>published literature) | | Performance | Bone formation | Bone formation | | Compatibility w/other<br>devices | Can be used with GTR<br>membrane | Can be used with GTR<br>membrane | | Sterilization Process | Sterile by Gamma<br>irradiation | Sterile by Gamma<br>irradiation | | Chemical Composition | Similar to Bio-Oss®<br>based on chemical<br>analyses, XRD, FT-IR,<br>and ICP analysis | Similar to EquiMatrix™<br>based on chemical<br>analyses, XRD, FT-IR,<br>and ICP analysis | | Chemical safety | Biocompatible | Biocompatible | | Anatomical sites | Oral, Periodontal | Oral, Periodontal | | Pyrogen Free | Yes | Yes | | Shelf life | 3 years | Determined by<br>Manufacturer | #### Substantial Equivalence Comparison Table 1 {3}------------------------------------------------ K///8/6 # Brief Summary of Data Submitted in Support of Effectiveness The Sponsor evaluated the performance characteristics of EquiMatrix™ and Bio-Oss® with a thorough chemical and physical characterization. The physical and chemical characteristics of the products were found to be comparable. Further, {4}------------------------------------------------ K///8/6 in several animal studies, both products were found to grow new bone and be subsequently resorbed at similar rates. Finally, in a clinical case series, use of EquiMatrix™ resulted in defect healing and formation of new bone of sufficient quality to obtain dental implant placement. #### Brief Summary of Data Submitted in Support of Safety EquiMatrix™ was the subject of the full range of biocompatibility tests recommended in the FDA's "Class II Special Controls Guidance Document: Dental Bone Grafting Devices" and in accordance with ISO 10993. Test results confirmed product safety. Organic material has been removed from the product, and product specifications have been established to limit protein content. Further, the product is sterilized to achieve a sterility assurance level SAL 1 x 10°. Based on the information presented herein, it has been demonstrated that EquiMatrix™ is substantially equivalent to Bio-Oss®, and safe and effective for the proposed indications for use. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows a logo for the Department of Health & Human Services. The logo features a stylized abstract symbol resembling three curved lines or waves, positioned to the right. To the left of the symbol, the text "DEPARTMENT OF HEALTH & HUM" is arranged vertically along the edge of the logo, followed by "SERVICES" below. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Ms. Marsha Simon Manager, Regulatory Affairs Luitpold Pharmaceuticals, Incorporated One Luitpold Drive P.O. Box 9001 Shirley, New York 11967 SEP 2 9 2011 Re: K111816 Trade/Device Name: EquiMatrix™ Natural Bone Mineral Matrix Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NPM Dated: September 23, 2011 Received: September 26, 2011 Dear Ms. Simon: 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. {6}------------------------------------------------ Page 2 -- Ms. Simon Enclosure . 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 (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.htmlfor 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 yours. Zh 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 {7}------------------------------------------------ 111816 # 1.0 Indications for Use Statement # INDICATIONS FOR USE 510(K) Number: EquiMatrix™ Natural Bone Mineral Matrix Device Name: # INDICATIONS AND USAGE: EQUIMATRIX™ cancellous and cortical granules are recommended for: - Augmentation or reconstructive treatment of the alveolar ridge. - - Filling of infrabony periodontal defects. - - Filling of defects after root resection, apicoectomy, and cystectomy. - - Filling of extraction sockets to enhance preservation of the alveolar ridge. - - Elevation of the maxillary sinus floor. - - Filling of periodontal defects in conjunction with products intended for Guided ﺖ Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR). - Filling of peri-implant defects in conjunction with products intended for Guided -Bone Regeneration (GBR). Prescription Use _ V AND/OR (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) Concurrence of CDRH, Office of Device Evaluation (ODE) Melle (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: K111816