MONTAGE-QS Settable, Resorbable Bone Putty

{0}------------------------------------------------ October 12, 2023 Image /page/0/Picture/1 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. Orthocon, Inc. Howard Schrayer Consultant 8 Lookout Hilton Head Island, SC 29928 Re: K231475 Trade/Device Name: MONTAGE-QS Settable, Resorbable Bone Putty Regulation Number: 21 CFR 882.5300 Regulation Name: Methyl Methacrylate For Cranioplasty Regulatory Class: Class II Product Code: GXP Dated: September 12, 2023 Received: September 12, 2023 Dear Howard Schrayer: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). {1}------------------------------------------------ Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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, Adam D. Digitally signed by Adam D. Pierce -S Digitally signed by Date: 2023.10.12 Pierce -S 14:48:11 -04'00' Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality {2}------------------------------------------------ Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K231475 Device Name Montage-OS Settable, Resorbable Bone Putty #### Indications for Use (Describe) Orthocon MONTAGE-OS Settable Bone Putty is a self-setting calcium phosphate cement indicated for use in the repair of neurosurgical burr holes, contiguous cranial defects with a surface area no larger than 25cm2. MONTAGE-QS Settable, Resorbable Bone Putty should be used only in skeletally mature individuals. | Type of Use (Select one or both, as applicable) | | | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------| | <table border="0"><tr><td><div> <span> <b> </b> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div></td><td><div> <span> <b> </b> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div></td></tr></table> | <div> <span> <b> </b> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <b> </b> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | | <div> <span> <b> </b> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <b> </b> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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 conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ ## 510(k) SUMMARY (Per 21 CFR 807.92) ## General Company Information | Name: | Orthocon, Inc. | |-----------------------------------------------------|-----------------------------------------------------------------------| | Contact: | Howard Schrayer<br>Regulatory Affairs Consultant | | Address: | 700 Fairfield Avenue, Suite 1<br>Stamford, CT 06902 | | Telephone: | (855) 475 - 9175 | | Date Prepared | October 9, 2023 | | General Device Information | | | Product Name: | MONTAGE-QS™ Settable Resorbable Bone Putty | | Common Name: | Calcium Phosphate Cement | | Classification: | Class II | | Product codes: | GXP | | Regulation: | 21 CFR 882.5300 | | Predicate Devices:<br>Primary Predicate:<br>Stryker | Stryker Injectable Cement<br>[510(k) Number K060763] | | Reference Devices:<br>Orthocon, Inc. | MONTAGE-QS Settable, Resorbable Bone Putty<br>[510(k) Number K191140] | | Orthocon, Inc. | MONTAGE Settable, Resorbable Bone Putty<br>[510(k) Number K221933] | ### Device Description MONTAGE-QS Settable, Resorbable Bone Putty is a sterile, biocompatible, resorbable material for use in repair of cranial defects. The MONTAGE-QS device comprises two separate components of putty consistency containing granular calcium phosphate, calcium stearate, vitamin E acetate, a triglyceride, polyalcohols and a mixture of a lactide-diester and polyesterbased polymers. When mixed together, the components of the MONTAGE-QS device form a putty-like material. The resulting hardened, resorbable material is primarily calcium phosphate. MONTAGE-QS components must be mixed immediately prior to use. {5}------------------------------------------------ ## Indications for Use Orthocon MONTAGE-QS Settable, Resorbable Bone Putty is a self-setting calcium phosphate cement indicated for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects with a surface area no larger than 25cm². MONTAGE-QS Settable, Resorbable Bone Putty should be used only in skeletally mature individuals. The following table shows comparisons of characteristics of MONTAGE-QS Settable, Resorbable Bone Putty and the predicate device. ### SUBSTANTIAL EQUIVALENCE INFORMATION ### Orthocon, Inc. MONTAGE-QS Settable, Resorbable Bone Putty 510(k) — K231475 Stryker Injectable Cement HydroSet 510(k) - K060763 ### Comparisons of Technological Characteristics | Device is intended for use in the repair of<br>neurosurgical burr holes, contiguous<br>craniotomy cuts and other cranial defects<br>with a surface area no larger than 25cm². | Stryker® Injectable Cement is intended for use<br>in the repair of neurosurgical burr holes,<br>contiguous craniotomy cuts and other cranial<br>defects. | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | At the time of application, device is in the<br>form of a putty-like material | At the time of application, device is in the form<br>of a paste-like material | | Device is designed to be manually applied to<br>the cranial defect | Device is designed to be manually applied to<br>the cranial defect | | MONTAGE-QS Settable, Resorbable Bone<br>Putty is formulated as a two-part putty/putty<br>device that forms a “settable” (hardening)<br>material when manually mixed at the time of<br>surgery | Stryker Injectable cement is formulated as a<br>two-part powder/liquid device that forms a<br>"settable" (hardening) material when manually<br>mixed at the time of surgery | | Sterile mixture of two separate components<br>of putty-like consistency comprised of<br>granular calcium phosphate,<br>(hydroxyapatite and β-tricalcium<br>phosphate), calcium stearate, vitamin E<br>acetate, triacetin, polyalcohols and a<br>mixture of a lactide-diester and polyester-<br>based (lactide and caprolactone)<br>absorbable polymers. MONTAGE-QS is to<br>be mixed immediately prior to use.<br>Resulting settable material from the two<br>putties is primarily comprised of calcium<br>phosphate. | Sterile mixture of two separate components, a<br>powder comprised of dicalcium phosphate<br>dihydrate, tetracalcium phosphate and tri-<br>sodium citrate; and a liquid comprised of<br>sodium phosphate, polyvinylpyrrolidone and<br>water. Stryker Injectable Cement is to be<br>manually mixed immediately prior to use.<br>Resulting settable material from the two<br>components is primarily comprised of calcium<br>phosphate. | | Implanted device is resorbable in greater<br>than 30 days primarily due to presence of<br>calcium phosphate. | Implanted device is resorbable in greater than<br>30 days primarily due to presence of calcium<br>phosphate. | {6}------------------------------------------------ | Single-patient-use device is provided sterile by gamma irradiation | Single-patient-use device is provided sterile by gamma irradiation and ethylene oxide | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------| | The bone putty is available in individual and/or multi-pack patient use sizes of up to 5cc (approximately 10 grams). | The device is available in individual; and/or multi-pack patient use sizes of 3, 5, 10 and 15cc. | | Each putty is placed into a separate inner foil “blister” which are contained within a single outer foil pouch. The outer foil pouch contains a desiccant. The inner blister and outer pouch are heat sealed and sterilized. | Each kit contains one liquid-filled glass syringe and one plastic bowl of powder packaged within a double pre-formed tray with a Tyvek lid. | | Mixing for homogeneity takes 30 sec. | Mixing for homogeneity takes 45 sec. | | Material is settable within 5 minutes of application | Material is settable within 10 minutes of application | | Material provides a working time of 1 minutes. | Material provides a working time of 2 minutes. | | Device cures with no appreciable exothermic reaction. | Device cures with no appreciable exothermic reaction | ## Testing Completed ## Efficacy Evaluation The cranioplasty efficacy performance of MONTAGE-QS was compared to HydroSet in a rabbit cranial critical-sized defect model. Test results confirmed that each device filled bone defects. From the histology-based assessments, MONTAGE-QS performance for cranioplasty was judged to be equivalent to HydroSet in this critical-sized defect model. ### Performance Data Performance testing included a series of laboratory evaluations and in vivo testing. These evaluations are summarized below. {7}------------------------------------------------ # Bench Testing | Test | Description | Conclusions | |----------------------------------------------|----------------------------------------------------------------------|---------------------------------------------------------------------| | Visual Inspection | Evaluated putty component color<br>using a reference scale | Putty color<br>met specification | | Putty Stiffness | Evaluated putty stiffness<br>using a reference scale | Putty stiffness met<br>specification | | Putty Vitamin E<br>Acetate<br>Concentration | Solvent extraction and chemical<br>analysis | Putty vitamin E acetate<br>concentration met specification | | Hand Mixing Time | Evaluated hand-mixing time using<br>a reference scale | Mixing time, stickiness, and<br>mixability met specification | | Hand Mixing<br>Stickiness | Evaluated stickiness<br>using a reference scale | | | Mixability | Evaluated mixability using a reference<br>scale | | | Package Leak Test | Bubble emission leak test | All test articles passed | | Temperature<br>Sensitivity | Determined maximum temperature<br>increase observed<br>during mixing | Acceptable maximum temperature<br>increase<br>following hand-mixing | | Water Uptake,<br>Swelling<br>and Dissolution | Measured volume and mass<br>changes over time | Acceptable water uptake,<br>swelling and dissolution | ### In-Vivo Testing In-vivo animal testing was used to demonstrate substantial equivalence of MONTAGE-QS Settable, Resorbable Bone Putty in the repair of a critical sized cranial bone defect in an animal model compared to the predicate device. Substantial equivalence was assessed from histopathologic evaluation. ### Biocompatibility Testing Testing was conducted to evaluate the device's biocompatibility in accordance with the recommendations of ISO 10993. The following biocompatibility studies were conducted on the final, finished, gamma-irradiation sterilized device and in accordance with the GLP requirements: cytotoxicity, irritation, systemic toxicity, genotoxicity, local tissue toxicity, hemolysis, pyrogenicity and neurotoxicity. ### Clinical Testing No clinical studies have been conducted in support of this 510(k). ### Conclusions This submission demonstrates that Orthocon MONTAGE-QS Settable, Resorbable Bone Putty is substantially equivalent to the predicate device.