Cerasorb Ortho Foam

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 December 2, 2016 Curasan AG % Dr. Karin Lübbers Managing Director YES Medical Device Services GmbH Bahnstrasse 42-46 Friedrichsdorf, Hesse 61381 Germany Re: K160566 Trade/Device Name: Cerasorb Ortho Foam Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: October 28, 2016 Received: October 31, 2016 Dear Dr. Lübbers: 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. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, Mark N. Melkerson -S Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use 510(k) Number (if known) K160566 Device Name Cerasorb Ortho Foam ## Indications for Use (Describe) Cerasorb Ortho Foam is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Cerasorb Ortho Foam resorbs and is replaced with bone during process. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.qov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the word "Yes" in white letters on a gray background. The "Y" has a green triangle above it. The background is a gray rectangle with rounded corners. # 510(k) Summary # 1. Submitter This 510(k) application was created in January 2016 The 510(k) owner for this application is: | Company | curasan AG | |------------------------------------|-----------------------------------------------| | Address | Lindigstr. 4<br>63801 Kleinostheim<br>Germany | | Phone: | +49-6027-40900-0 | | Fax: | +49-6027-40900-29 | | Email: | info@curasan.de | | Establishment registration number: | 3003771570 | Contact person: | Name: | Dr. Wolf-Dietrich Hübner | |-----------|--------------------------| | Position: | Medical Director | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "Yes" in white letters with a green triangle above the "Y". The word is set against a gray background that appears to have a glossy or reflective surface. The font is bold and sans-serif, giving the word a modern and clean look. 510(k) Application Image /page/4/Picture/3 description: The image contains the word "curasan" in red, lowercase letters. The font is sans-serif and the letters are slightly rounded. The word is presented horizontally and appears to be a logo or brand name. # 2. Device Name and Classification Proprietary / Trade Name: Common Name: Classification Name: Classification: Product Code Panel Cerasorb Ortho Foam Bone Void Filler Filler, Bone Void, Calcium Compound Class II per 21 CFR § 888.3045 MQV Orthopedic # 3. Predicate Device This application claims that Cerasorb Ortho Foam is substantially equivalent to the following predicate device: | 510(k) number | K 032288 | |---------------------------|-------------------------------------------------------------| | Proprietary / Trade Name: | Vitoss Scaffold Foam Bone Graft Material | | Common Name: | Bone Void Filler | | Classification Name: | Filler, Bone Void, Calcium Compound | | Classification: | Class II per 21 CFR § 888.3045 | | Product Code | MQV | | Panel | Orthopedic | | Manufacturer | Orthovita, Inc., 45 Great Valley Parkway, Malvern, PA 19355 | ## 4. Description Cerasorb Ortho Foam is a highly porous composite material for bone augmentation and regeneration applications, consisting of porcine collagen and a resorbable ceramic. Through the use of pure phase ß-tricalcium phosphate with a regular interconnected porous structure, a degradation of the biomaterial is achieved simultaneously to natural bone regeneration. The pure phase B-tricalcium phosphate is made according to ASTM F 1088-04a. The ß-tricalcium phosphate component of Cerasorb Ortho Foam is a mixture of Cerasorb M Ortho and Cerasorb Ortho, which received previous 510(k) clearances (K040216 and K014156, respectively). The device has been tested to meet pyrogen limit specifications. Cerasorb Ortho Foam is available in five different sizes and two versions (mouldable foam and flexible foam strip) and serves to fill bone defects in the entire skeletal system. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "Yes" in white letters on a gray background. The "Y" has a green triangle above it. The letters are in a sans-serif font and are slightly italicized. The background is a gradient of gray, with the lighter shade at the top and the darker shade at the bottom. Image /page/5/Picture/2 description: The image shows the word "curasan" in red, lowercase letters. The letters are slightly tilted to the right, giving the word a dynamic appearance. The font is bold and sans-serif, contributing to the modern and clean look of the logo. The background is plain white, which makes the red letters stand out. Cerasorb Ortho Foam | Available sizes: | |------------------------------------| | Product name | | Cerasorb Ortho Mouldable Foam | | Cerasorb Ortho Mouldable Foam | | Cerasorb Ortho Mouldable Foam | | Cerasorb Ortho Flexible Foam Strip | | Cerasorb Ortho Flexible Foam Strip | Dimensions LxWxH [mm] 25x25x4 25x50x4 25x100x4 25x50x4 25x100x4 # 5. Intended Use Cerasorb Ortho Foam is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Cerasorb Ortho Foam resorbs and is replaced with bone during the healing process. # 6. Substantial Equivalence Cerasorb Ortho Foam is substantially equivalent to the predicate device Vitoss Scaffold Foam Bone Graft Material. Please refer to the table below that discusses the substantial equivalence of the two devices in detail. | Device Comparison Table | | | |--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Feature | Proposed device:<br>Cerasorb Ortho Foam | Predicate device<br>Vitoss Scaffold Foam Bone Graft<br>Material | | Intended use | Cerasorb Ortho Foam is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Cerasorb Ortho Foam resorbs and is replaced with bone during the healing process. | Vitoss Scaffold Foam Bone Graft Material is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Vitoss Scaffold Foam is indicated for use in the treatment of surgically created osseous defects or osseous defects created from traumatic injury to the bone. Vitoss Scaffold Foam should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously. Vitoss Scaffold Foam Bone Graft Material is intended to be used for filling bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). Following placement in the bony void or gap, the scaffold resorbs and is replaced with bone during the healing process. | | Abbreviated intended use | Bone void filler | Bone void filler | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the word "Yes" in a stylized font. The "Y" is white and has a green triangle above it, while the "es" is white and slightly blurred. The background is a gradient of gray, with the darker shade at the bottom and the lighter shade at the top. The overall design is simple and modern. Image /page/6/Picture/3 description: The image shows the word "curasan" in red, lowercase letters. The font is sans-serif and the letters are slightly rounded. The word is displayed horizontally and is the only element in the image. | Device Comparison Table | | | |-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------| | Feature | Proposed device:<br>Cerasorb Ortho Foam | Predicate device<br>Vitoss Scaffold Foam Bone Graft<br>Material | | Target Population | Individual with bony defect resulting from surgery or trauma | Individual with bony defect resulting from surgery or trauma | | Anatomical locations | Bony voids or gaps of the skeletal system, i. e., the extremities and pelvis | Bony voids or gaps of the skeletal system, i. e., the extremities, spine and pelvis | | Labeling | Contains comparable intended use, warnings, and precautions as the labeling of the Vitoss Scaffold Foam Bone Graft Material. The wording is not identical, but substantially equivalent. | - | | Materials | | | | Chemical composition | Calcium salt with Type I and Type III porcine collagen | Calcium salt with Type I bovine collagen | | Mineral phases | $ β $ -Tricalcium phosphate Ca3(PO4)2 | $ β $ -Tricalcium phosphate Ca3(PO4)2 | | Design | | | | Physical structure | Trabecular structure similar to cancellos bone | Trabecular structure similar to cancellos bone | | Pore size (range) | 0.1-500 $ μ $ m | 1-1000 $ μ $ m | | Performance | | | | Osteoconductivity | Osteoconductive | Osteoconductive | | Mechanical strength | Does not impart mechanical strength to surgical site | Does not impart mechanical strength to surgical site | | Sterility | Sterilized by gamma irradiation, single use only | Sterilized by gamma irradiation, single use only | | Biocompatibility | Established | Established | | Dosage Form(s) | Strips, Packs | Cylinders (Blocks), Strips, Packs, Flow, Shapes | One difference between Cerasorb Ortho Foam and the predicate device is that porcine collagen type I and type III was used instead of bovine collagen. This change was done for safety reasons as for porcine collagen the risk of Transmissible Spongiform Encephalopathy transmission is reduced. Moreover, the pore size of the integrated ß-tricalcium phosphate particles is on the average smaller for Cerasorb Ortho Foam, but within the same range. No significant functional implications are expected. Based on the identified characteristics it is claimed that the device is substantially equivalent to the predicate device. # 7. Performance Testing A comparative study in sheep using the critical size defect model was performed. Cerasorb Ortho Flexible Foam Strip and Cerasorb Ortho Mouldable Foam were tested and compared to the predicate device Vitoss Scaffold Foam Bone Graft Material. The amount and quality {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the word "Yes" in white letters on a gray background. The "Y" has a green triangle above it. The letters are in a bold, sans-serif font. The background is a gradient, with the top being lighter than the bottom. Cerasorb Ortho Foam Image /page/7/Picture/3 description: The image shows the word "curasan" in red, lowercase letters. The letters are slightly rounded and have a uniform thickness. The word is presented in a simple, sans-serif font. The background is plain white, which makes the red letters stand out. of the newly formed bone was evaluated as well as the occurrence of fibrosis and inflammation at the surgical site. It was concluded that Cerasorb Ortho Flexible Foam Strip and Cerasorb Ortho Mouldable Foam performed at least as well as the predicate device Vitoss Scaffold Foam Bone Graft. Based on the functional testing performed, substantial equivalence to the predicate device Vitoss Scaffold Foam Bone Graft Material is given.