FIBERGRAFT Aeridyan Matrix Bone Graft Substitute

{0}------------------------------------------------ August 23, 2022 Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The logos are simple and professional, and they are likely used to identify the organizations on official documents and websites. Prosidyan, Inc % Janice M. Hogan Regulatory Counsel Hogan Lovells US LLP 1735 Market Street, Suite 2300 Philadelphia, Pennsylvania 19103 Re: K213803 Trade/Device Name: FIBERGRAFT® Aeridyan™ Matrix Bone Graft Substitute Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: July 19, 2022 Received: July 19, 2022 Dear Janice Hogan: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Laura C. Rose, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement on last page 510(k) Number (if known) K213803 Device Name FIBERGRAFT® Aeridyan™ Matrix Bone Graft Substitute Indications for Use (Describe) FIBERGRAFT® Aeridyan™ Matrix - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT® Aeridyan™ Matrix is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the posterolateral spine, extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. FIBERGRAFT® Aeridyan™ Matrix must be used with autogenous bone marrow aspirate and autograft in posterolateral spine. FIBERGRAFT® Aeridyan™ Matrix must be hydrated with saline or blood for pelvis and extremity applications. Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) □ Over-The-Counter Use (21 CFR 801 Subpart C) # PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. # FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 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.gov "An agency may not conductor sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number. {3}------------------------------------------------ ## 510(k) SUMMARY # Prosidyan, Inc.'s FIBERGRAFT® Aeridyan™ Matrix - Bone Graft Substitute ## Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared Prosidyan, Inc. 41 Spring Street #107 New Providence, NJ 07974 Phone: (908) 517-3666 Facsimile: (908) 396-1151 Contact Person: Gina M. Nagvajara, PhD Date Prepared: July 19, 2022 #### Name of Device and Name FIBERGRAFT® Aeridyan™ Matrix Bone Graft Substitute ## Common or Usual Name Filler, Bone Void, Calcium Compound Classification Name/CFR Regulation/Product Code Resorbable Calcium Salt Bone Void Filler, 21 CFR 888.3045, product code MQV #### Predicate Device - · Prosidyan Inc, FIBERGRAFT BG Matrix (K180080) ## Reference Devices - · NovaBone Products LLC, NovaBone MacroFORM (K140946) - Prosidyan, Inc., FIBERGRAFT® AERIDYAN Matrix (K182670) ## Intended Use / Indications for Use FIBERGRAFT® Aeridyan™ Matrix - Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT® Aeridyan™ Matrix is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the posterolateral spine, extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. FIBERGRAFT® Aeridyan™ Matrix must be used with autogenous bone marrow aspirate and autograft in posterolateral spine. FIBERGRAFT® Aeridyan™ Matrix must be hydrated with saline or blood for pelvis and extremity applications. ## Device Description FIBERGRAFT® Aeridyan™ Matrix product is composed of 4585 bioactive glass (M-45 granules), boron bioactive glass (MS-B microspheres/Borospheres™) and bovine type I collagen. After hydration with saline, blood or bone marrow aspirate (BMA), the Aeridyan™ Matrix can be applied directly to the defect site or molded into the desired shape and gently packed into the defect site as a non-setting putty. In posterolateral spine fusion applications, the product is intended to be hydrated with bone marrow aspirate (BMA) and mixed with autograft in a recommended 1:1 ratio. In pelvis and extremity applications, the product must be hydrated with saline or blood. {4}------------------------------------------------ The FIBERGRAFT® AERIDY AN Matrix product was previously cleared in K182670. There have been no technological changes to the device since this last clearance - the formulation, raw materials and critical raw material suppliers remain the same. The intent of this submission is to expand the indication in the pelvis and extremities based on completion of an additional functional animal study. #### Technological Characteristics The FIBERGRAFT Aeridyan Matrix is of the same composition as the previously cleared FIBERGRAFT Aeridyan Matrix in K182670; and also similar in composition to the previously cleared FIBERGRAFT BG Matrix (K180080). All products are resorbable, osteoconductive, bioactive bone void filler devices that are composed of bioactive glass and bovine collagen. The comparison among the devices is shown in the table below. {5}------------------------------------------------ | | Prosidyan's FIBERGRAFT®<br>Aeridyan ™ Matrix<br>(Subject Device) | Prosidyan's FIBERGRAFT® BG<br>Matrix (K180080)<br>(Predicate Device) | NovaBone MacroFORM (K140946)<br>(Reference Device) | Prosidyan's FIBERGRAFT®<br>AERIDYAN Matrix (K182670)<br>(Reference Device) | | Prosidyan's FIBERGRAFT®<br>Aeridyan ™ Matrix<br>(Subject Device) | Prosidyan's FIBERGRAFT® BG<br>Matrix (K180080)<br>(Predicate Device) | NovaBone MacroFORM (K140946)<br>(Reference Device) | Prosidyan's FIBERGRAFT®<br>AERIDYAN Matrix (K182670)<br>(Reference Device) | |-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|------------------------------------------------------------------|----------------------------------------------------------------------|----------------------------------------------------|----------------------------------------------------------------------------| | Intended Use | Bone void filler for orthopedic<br>applications | Bone void filler for orthopedic<br>applications | Bone void filler for orthopedic<br>applications | Bone void filler for orthopedic<br>applications | Primary Component | 45S5 Bioactive Glass, Boron<br>bioactive glass | 45S5 Bioactive Glass | 45S5 Bioactive Glass | 45S5 Bioactive Glass, Boron<br>bioactive glass | | Indications for Use | FIBERGRAFT® Aeridyan ™ Matrix<br>- Bone Graft Substitute is indicated<br>only for bony voids or gaps that are<br>not intrinsic to the stability of the<br>bony structure. FIBERGRAFT®<br>Aeridyan™ Matrix is indicated to<br>be gently packed into bony voids<br>or gaps of the skeletal system (i.e.,<br>the posterolateral spine,<br>extremities and pelvis). These<br>defects may be surgically created<br>osseous defects or osseous<br>defects created from traumatic<br>injury to the bone. The product<br>provides a bone void filler that<br>resorbs and is replaced with bone<br>during the healing process.<br>FIBERGRAFT® Aeridyan ™ Matrix<br>must be used with autogenous<br>bone marrow aspirate and<br>autograft in posterolateral spine.<br>FIBERGRAFT® Aeridyan ™ Matrix<br>must be hydrated with saline or<br>blood for pelvis and extremity<br>applications. | FIBERGRAFT® BG Matrix - Bone<br>Graft Substitute is indicated only<br>for bony voids or gaps that are not<br>intrinsic to the stability of the bony<br>structure. FIBERGRAFT® BG<br>Matrix is indicated to be gently<br>packed into bony voids or gaps of<br>the skeletal system (i.e.,<br>posterolateral spine, extremities<br>and pelvis). These defects may be<br>surgically created osseous defects<br>or osseous defects created from<br>traumatic injury to the bone. The<br>product provides a bone void filler<br>that resorbs and is replaced with<br>bone during the healing process.<br>FIBERGRAFT® BG Matrix must<br>be used with autogenous bone<br>marrow aspirate and autograft in<br>posterolateral spine. | NovaBone MacroFORM<br>graft devices are indicated only for<br>bony voids or gaps that are not<br>intrinsic to the stability of the bony<br>structure. NovaBone MacroFORM<br>is indicated to be gently packed<br>into bony voids or gaps of the<br>skeletal system (i.e. the<br>extremities and pelvis). These<br>defects may be surgically created<br>osseous defects or osseous<br>defects created from traumatic<br>injury to the bone. NovaBone<br>MacroFORM must be hydrated<br>with autogenous bone marrow<br>prior to implantation. The product<br>provides a bone void filler that<br>resorbs and is replaced with bone<br>during the healing process. | AERIDYAN<br>FIBERGRAFT®<br>Matrix - Bone Graft Substitute is<br>indicated only for bony voids or<br>gaps that are not intrinsic to the<br>stability of the bony structure.<br>FIBERGRAFT®<br>AERIDYAN<br>Matrix is indicated to be gently<br>packed into bony voids or gaps of<br>the skeletal system (i.e.,<br>posterolateral spine). These<br>defects may be surgically created<br>osseous defects or osseous<br>defects created from traumatic<br>injury to the bone. The product<br>provides a bone void filler that<br>resorbs and is replaced with bone<br>during the healing process.<br>FIBERGRAFT® AERIDYAN<br>Matrix must be used with<br>autogenous bone marrow aspirate<br>and autograft in posterolateral<br>spine. | Collagen<br>composition | Type I Collagen from bovine | Type I Collagen from bovine | Type I Collagen from bovine | Type I Collagen from bovine | | Target Population | Individuals with surgically created<br>osseous defects or osseous<br>defects due to traumatic injury to<br>bone. | Individuals with surgically created<br>osseous defects or osseous<br>defects due to traumatic injury to<br>bone. | Individuals with surgically created<br>osseous defects or osseous<br>defects due to traumatic injury to<br>bone. | Individuals with surgically created<br>osseous defects or osseous<br>defects due to traumatic injury to<br>bone. | Osteoconductive | Yes | Yes | Yes | Yes | | Anatomical<br>Placement | Posterolateral spine, Extremities<br>and Pelvis | Posterolateral spine, Extremities<br>and Pelvis | Extremities and Pelvis | Posterolateral spine | Bioactive | Yes | Yes | Yes | Yes | | Resorbs | Yes | Yes | Yes | Yes | | | | | | | Sterility | Sterile | Sterile | Sterile | Sterile | | | | | | | Biocompatibility | Biocompatible | Biocompatible | Biocompatible | Biocompatible | | | | | | | Packaging | Thermo-form tray | Thermo-form tray | Thermo-form tray and sealed cups | Thermo-form tray | | | | | | {6}------------------------------------------------ # K213803 {7}------------------------------------------------ ## Performance Data The performance of the FIBERGRAFT® Aeridyan Matrix has been established by undertaking physical and chemical property evaluation studies, functional performance animal studies and biocompatibility tests. The physical and chemical property studies confirmed the in vitro functionality and bioactivity of the Aeridyan Matrix. The in vitro bioactivity test results have not been correlated to clinical performance. The biocompatibility of the FIBERGRAFT® Aeridyan Matrix has been demonstrated by ISO 10993 testing and the long history of clinical use of the bioactive glass material for the same intended use. In addition, the Aeridyan Matrix is composed of the same bioactive glass material and the same type and duration of patient as the predicates. Packaging evaluations, shelf life testing and real time aging testing were performed with passing results. Bacterial endotoxin testing was performed using the limulus amebocyte lysate (LAL) method and showed that the device meets the endotoxin limits of established guidelines. The FIBERGRAFT® Aeridyan Matrix product was evaluated in a rabbit posterolateral spine fusion study to support device performance for its indications for use in the FIBERGRAFT® Aeridyan Matrix product was compared to the FIBERGRAFT® BG Matrix predicate device as well as controls. The animal study evaluated device performance in critical sized cancellous bone in the posterolateral spine of 71 skeletally mature rabbits. The performance was evaluated using radiographic, histomorphometric, and biomechanical data. Testing of the FIBERGRAFT® Aeridyan Matrix in the rabbit model is representative of the indications for use and range of anatomical sites proposed for the subject device. The results of the study through 26 weeks of follow-up demonstrated that the FIBERGRAFT® Aeridyan Matrix device performs substantially equivalently to the predicate device and positive control, and any minor technological differences between the device groups do not raise new types of safety or effectiveness concerns. The FIBERGRAFT® Aeridyan Matrix product has also been evaluated in a rabbit femoral condyle defect study in skeletally mature rabbits to further support device performance for use in extremities and pelvis applications. The FIBERGRAFT® Aeridyan Matrix product was compared to the BG Matrix and NovaBone MacroFORM predicate and reference devices. The animal study evaluated device performance in critical sized defects in the distal femur of 44 skeletally mature rabbits. The performance was evaluated using radiographic, histological, and histomorphometric data. Testing of the FIBERGRAFT® Aeridyan Matrix in the rabbit model is representative of the indications for use and range of anatomical sites proposed for the subject device. The results of the study through 26 weeks of follow up demonstrated that the FIBERGRAFT® Aeridyan Matrix device performs substantially equivalently to the predicate and reference devices, and any minor technological differences between the device groups do not adversely impact performance. Therefore, performance testing demonstrated that the FIBERGRAFT® Aeridyan Matrix device functions as intended and meets the requirements of class II bone void fillers as compared to the predicate device and reference devices. #### Substantial Equivalence As demonstrated in performance testing, the FIBERGRAFT® Aeridyan Matrix has the same intended use and similar indications, technological characteristics, and principles of operation as the predicate and reference devices. The minor technological differences between Aeridyan Matrix and its predicate device do not raise any new issues of safety or effectiveness. The data demonstrated that Aeridyan Matrix is substantially equivalent to the predicate device. ## Conclusion FIBERGRAFT® Aeridyan Matrix is an osteoconductive, resorbable bone graft substitute composed of bioactive glass, mixed with type I collagen. The FIBERGRAFT® Aeridyan Matrix is substantially equivalent to its predicate and reference devices for its intended use as a synthetic bone void filler. Performance {8}------------------------------------------------ testing, including in vivo data, demonstrated that the device functions as intended, supporting substantial equivalence.