Osteo-P Bone Graft Substitute

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. December 29, 2017 Molecular Matrix, Inc. % Mr. John Kapitan Chief Executive Officer Kapstone Medical P.O. Box 969 Leicester, North Carolina 28748 Re: K170165 Trade/Device Name: Osteo-PTM Bone Graft Substitute Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MOV Dated: November 27, 2017 Received: November 30, 2017 Dear Mr. Kapitan: 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. 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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 {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device 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. 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. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Mark N. Melkerson -S Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K170165 Device Name Osteo-PTM Bone Graft Substitute #### Indications for Use (Describe) Osteo-PIM Bone Graft Substitute is indicated for use only in the treatment of bony voids or gaps that are not intrinsic to the stability of the bony structure. It is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis), and the opening to the defect site sealed with bone wax. These defects may be surgically created osseous defects or osseous defects created from traumatic or degenerative injury to the bone. Subsequent to implantation, Osteo-PTM Bone Graft Substitute is resorbed and replaced with bone during the healing process. | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------| | <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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In accordance with 21 CFR 807.87(h) and 21 CFR 807.92, the 510(k) summary for Osteo-P™ is provided below. | Date Summary Prepared: | November 17, 2017 | |-----------------------------------------------------------------|-------------------------------------------------------------------------| | Submitter Name: | Molecular Matrix, Inc. | | Submitter Address: | 3410 Industrial Blvd., Suite 103<br>West Sacramento, CA. 95691 | | Contact Person: | John Kapitan<br>Kapstone Medical, LLC | | Phone Number:<br>Fax Number: | 916-374-9404<br>530-231-6126 | | Device Trade Name: | Osteo-PTM Bone Graft Substitute | | Device Common Name: | Resorbable bone void filler | | Classification Name:<br>Classification Number:<br>Product Code: | Bone Void Filler Device<br>21 CFR 888.3045<br>MQV | | Primary Predicate Device:<br>Reference Device: | K063359 ISTO Technologies, Inc. InQu®<br>K043045 Synthes (USA) chronOS® | ### Device Description Osteo-PTM Bone Graft Substitute is a radiolucent bone void filler composed of a porous, osteoconductive polymeric carbohydrate with a trabecular structure simulating the multidimensional interconnectivity of human cancellous bone. When placed in direct contact with host bone, Osteo-PTM supports and guides the ingrowth of new bone across the graft site and is resorbed as the healing process occurs. The consistency of Osteo-P™ allows the surgeon to easily manipulate and maximize the direct contact with viable host bone. It is intended for single patient use only and is provided sterile in single-use double sterile packaging. Osteo-P™ is available in various forms to include granules, sheets, cubes, wedges, and cylinders. {4}------------------------------------------------ ## Indications for Use Osteo-PTM Bone Graft Substitute is indicated for use only in the treatment of bony voids or gaps that are not intrinsic to the stability of the bony structure. It is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis), and the opening to the defect site sealed with bone wax. These defects may be surgically created osseous defects or osseous defects created from traumatic or degenerative injury to the bone. Subsequent to implantation. Osteo-PTM Bone Graft Substitute is resorbed and replaced with bone during the healing process. ## Technological Characteristics Testing has confirmed Osteo-P™ Bone Graft Substitute to be biocompatible as a bone void filler device. Animal testing demonstrated evidence of new bone formation consistent with FDA's recommendations for performance testing of Class II Bone Void Filler Devices. Osteo-P™ is substantially equivalent to the predicate device in terms of design, function, intended use and bone healing performance in an animal model. Results from a NZW Rabbit femoral condyle critical-sized defect study comparing Osteo-P™ to the predicate device and autograft as well as extensive biocompatibility testing demonstrated that the differences in raw material composition do not raise new issues of safety and effectiveness. | Characteristic | Osteo-PTM Bone Graft<br>Substitute<br>(subject device) | InQu® Bone Graft<br>Substitute<br>(predicate device) | chronOS® Bone Void<br>Filler<br>(reference device) | Comparison | |----------------------------------|-----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|--------------------------------------| | 510(k) | | K063359 | K013072 | N/A | | Intended Use | Resorbable Bone void<br>Filler | Resorbable Bone void<br>Filler | Resorbable Bone void<br>Filler | Equivalent | | Target Population | Individuals with bony<br>defects resulting from<br>surgery or trauma; not<br>intrinsic to the stability of<br>the structure | Individuals with bony<br>defects resulting from<br>surgery or trauma; not<br>intrinsic to the stability of<br>the structure | Individuals with bony<br>defects resulting from<br>surgery or trauma; not<br>intrinsic to the stability of<br>the structure | Equivalent | | Anatomical<br>Location | Bony voids or gaps of the<br>skeletal system, (i.e., the<br>extremities and pelvis) | Bony voids or gaps of the<br>skeletal system, (i.e., the<br>extremities and pelvis) | Bony voids or gaps of the<br>skeletal system, (i.e., the<br>extremities, spine and<br>pelvis) | Equivalent to<br>predicate<br>device | | Technological<br>Characteristics | | | | | | Principle of<br>Operation | Provide Osteoconductive<br>Matrix | Provide Osteoconductive<br>Matrix | Provide Osteoconductive<br>Matrix | Equivalent | | Material of<br>Construction | Porous osteoconductive<br>polymer matrix | Porous osteoconductive<br>polymer matrix | Porous osteoconductive<br>polymer matrix | Equivalent | | Shapes | Variety (to include):<br>Granules, Sheets, Cubes,<br>Wedges, and Cylinders | Variety: Granules and<br>Sheets | Variety (to include):<br>Granules, Blocks, Wedges,<br>and Cylinders | Equivalent to<br>reference<br>device | | Sizes | Granules: 1-5mm<br>Preformed shapes: Variety | Granules: 2-5mm<br>Sheets: Variety | Granules: 1.4mm-2.8mm &<br>2.8mm-5.6mm.<br>Preformed shapes: Variety | Equivalent | ## Substantial Equivalence {5}------------------------------------------------ | Molecular Matrix, Inc. | | | | Traditional 510(k) | |---------------------------------------------|-----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|--------------------------------------| | Porosity | 75-95% | 75-90% | 60-70% | Equivalent to<br>predicate<br>device | | Pore Size | ~1-700 µm<br>main distribution: 50-500<br>µm | ~1-300µm | Macropores: 100-500µm<br>(main distribution)<br>Micropores: <10 µm | Equivalent | | Radiolucency | Radiolucent | Radiolucent | Radiopaque | Equivalent to<br>predicate<br>device | | Performance | | | | | | Surgical<br>Application<br>Restrictions/Use | Gently packed into defect.<br>Requires appropriate<br>fixation/stabilization.<br>Requires hydration | Gently packed into defect.<br>Requires appropriate<br>fixation/stabilization.<br>Requires hydration. | Gently packed into defect.<br>Requires appropriate<br>fixation/stabilization.<br>Requires hydration | Equivalent | | Osteoconductivity | Osteoconductive | Osteoconductive | Osteoconductive | Equivalent | | Resorbable | Yes | Yes | Yes | Equivalent | | Mechanical<br>Strength | Does not impart mechanical<br>strength to surgical site. | Does not impart mechanical<br>strength to surgical site. | Compressive strength<br>~5MPa | Equivalent to<br>predicate<br>device | | Packaging | Double sterile pack. | Double sterile pack | Double sterile pack. | Equivalent | | Sterility | Sterile, SAL 10-6 | Sterile, SAL 10-6 | Sterile, SAL 10-6 | Equivalent | | Sterilization<br>Method | E-Beam | E-Beam | E-Beam | Equivalent | | Pyrogenicity | Non-pyrogenic<br>Limulus Amebocyte Lysate<br>(LAL) Chromogenic<br>Endotoxin Quantitation<br>Assay | Non-pyrogenic | Non-pyrogenic | Equivalent | | Biocompatibility | Biocompatible | Biocompatible | Biocompatible | Equivalent | The following technological differences exist between the subject and predicate or reference devices: | Characteristic | Osteo-PTM | InQu® | chronOS® | |----------------------|-----------------------------------------------------|-------------------------|----------------------------------------| | | (subject device) | (predicate device) | (reference device) | | Material Composition | Porous Hyper Cross-linked<br>Polymeric Carbohydrate | Porous PGLA / HA matrix | Porous β-Tricalcium<br>Phosphate (TCP) | Pre-Clinical Testing confirmed that despite differences in material composition, Osteo-P™ is equivalent to the predicate device in function, indication for use, device classification product code, environment of use, and principles of operation to the predicate device. The biocompatibility of Osteo-P™ has also been confirmed through extensive in vitro and in vivo testing.