Who is the manufacturer of Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste?

Orthocon, Inc. filed the 510(k) submission for Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste (K231386).

What is the FDA product code for Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste?

MTJ. as a Class U device in the OR panel.

What is the regulatory pathway for Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste

K231386 · Orthocon, Inc. · MTJ · Jul 11, 2023 · OR

Device Facts

Record ID	K231386
Device Name	Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste
Applicant	Orthocon, Inc.
Product Code	MTJ · OR
Decision Date	Jul 11, 2023
Decision	SESE
Submission Type	Traditional
Device Class	Class U
Attributes	Therapeutic

Intended Use

Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste is indicated for the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade.

Device Story

Sterile, resorbable, two-part paste-like material; comprised of granular calcium phosphate, calcium stearate, vitamin E acetate, triglyceride, polyalcohols, lactide-diester/polyester-based polymers, and barium sulfate. Components mixed immediately prior to use; applied manually to bleeding bone surfaces via single-use applicator. Hardens in situ to form mechanical barrier (tamponade) occluding vascular openings. Used in surgical settings; operated by physicians. Provides local hemostasis; resorbable over >30 days via dissolution, hydrolysis, and cellular removal. Radiopaque due to barium sulfate addition.

Clinical Evidence

Bench testing only. Evaluations included handling properties (stiffness, spreadability, stickiness), temperature sensitivity, electrocautery compatibility, dissolution, and swelling. Biocompatibility testing performed per ISO 10993 (irritation, sensitization, acute systemic toxicity, genotoxicity, implantation, hemolysis, endotoxicity, pyrogenicity). Animal studies demonstrated intraoperative in vivo hemostasis and resistance to irrigation.

Technological Characteristics

Two-part paste system; components: granular calcium phosphate, calcium stearate, vitamin E acetate, triglyceride, polyalcohols, lactide-diester/polyester-based polymers, barium sulfate. Hardens post-mixing. Radiopaque. Resorbable (>30 days). Gamma-irradiated (SAL 10^-6). MRI safe. Manual application via delivery instrument.

Indications for Use

Indicated for control of bleeding from cut or damaged bone in patients requiring bone hemostasis via mechanical barrier or tamponade.

Predicate Devices

HBP6 Settable, Resorbable Hemostatic Bone Putty (K193052)

Reference Devices

Norian® XR (Extra Radiopaque) Calcium Phosphate Bone Void Filler (K023862)

Related Devices

K232998 — Montage- XT Settable, Resorbable Hemostatic Bone Putty · Orthocon, Inc. · Oct 12, 2023
K193052 — HBP6 Settable, Resorbable Hemostatic Bone Paste · Orthocon, Inc. · Mar 27, 2020
K213418 — MONTAGE Settable, Resorbable Hemostatic Bone Putty · Orthocon, Inc. · Aug 30, 2023
K143069 — HEMASORBPLUS press Resorable Hemostatic Bone Putty · Orthocon, Inc. · Dec 22, 2014
K152005 — MONTAGE Settable, Resorbable Hemostatic Bone Putty · Orthocon, Inc. · Oct 15, 2015

Submission Summary (Full Text)

{0}------------------------------------------------ July 11, 2023 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text. Orthocon, Inc. % Howard Schrayer Consultant Orthocon. Inc 700 Fairfield Ave - Suite 1 Stamford. CT 06902 Re: K231386 Trade/Device Name: Montage XRO Settable, Resorbable Hemostatic Bone Paste Regulatory Class: Unclassified Product Code: MTJ Dated: May 12, 2023 Received: May 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 (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). Sincerelv. # Jesse Muir -S Jesse Muir, 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}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K231386 Device Name Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste Indications for Use (Describe) Montage Flowable XRO Settable Hemostatic Bone Paste is indicated for the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade. | 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) #### 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.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." {3}------------------------------------------------ # 510(k) Summary | Contact: | Howard Schrayer Orthocon, Inc. 700 Fairfield Avenue - Suite 1 Stamford, CT 06902 USA Telephone: 609-273-7350 hs.ss@lucidmedical.net | |------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------| | Date Prepared: | May 12, 2023 | | Device Trade Name: | Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste | | Manufacturer: | Orthocon, Inc. 700 Fairfield Avenue - Suite 1 Stamford, CT 06902 USA | | Common Name: | Calcium phosphate bone hemostasis material | | Classification: | Unclassified | | Product Code: | MTJ | | Predicate Devices: Primary Predicate: | Orthocon, Inc. HBP6 Settable, Resorbable Hemostatic Bone Putty 510(k) K193052 | | Reference Device: | Synthes, Inc. Norian® XR (Extra Radiopaque) Calcium Phosphate Bone Void Filler 510(k) K023862 | {4}------------------------------------------------ #### Indications for Use: Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste is indicated for the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade. ## Device Description: Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste is a sterile, biocompatible, resorbable material for use in the control of bleeding from bone surfaces. The single use device contains two separate components of paste-like consistency comprised of granular calcium phosphate, calcium stearate, vitamin E acetate, a triglyceride, polyalcohols, a mixture of a lactide-diester and polyester-based polymers and barium sulfate. When mixed together, the components of the device form a resorbable paste-like material that can be applied directly to bleeding bone by means of a single-use applicator (delivery device). The resulting hardening paste is primarily comprised of calcium phosphate. Montage Flowable XRO is mixed immediately prior to use. When applied to surgically cut or traumatically broken bone. Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste achieves local control of bleeding by acting as a mechanical barrier (tamponade). #### Substantial Equivalence and Predicate Devices: The device was shown to be substantially equivalent to the previously cleared, predicate, HBP6 Settable, Resorbable Hemostatic Bone Putty (K193052). The following table shows comparisons of the several characteristics of Montage Flowable XRO Settable, Resorbable Bone Paste and the primary predicate device. The differences noted in the table below do not impact substantial equivalence. | Manufacturer | Orthocon, Inc. Predicate Device | Orthocon, Inc. Subject Device | |---------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade Name | HBP6 Settable, Resorbable Hemostatic Bone Paste | Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste | | 510(k) Number | K193052 | TBD | | Type of Device/ Product Code | Bone wax / MTJ | Bone wax / MTJ | | | HBP6 Settable, Resorbable | Montage Flowable XRO Settable, | | Indications for Use | HBP6 Settable, Resorbable Hemostatic Bone Paste is indicated in the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade | Resorbable Hemostatic Bone Paste is indicated in the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade | | Intended Use | Bone hemostasis | Bone hemostasis | | Mechanism of Action | Mechanical tamponade that occludes vascular openings in damaged bone | Mechanical tamponade that occludes vascular openings in damaged bone | | Form of Device | HBP6 Settable, Resorbable Hemostatic Bone Paste is formulated as a two-part paste/paste device that forms a "settable" (hardening) paste when mixed at the time of surgery. | Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste is formulated as a two-part paste/paste device that forms a "settable" (hardening) paste when mixed at the time of surgery. | | Radiopacity | Radiopaque – Contains hydroxyapatite and β-tricalcium phosphate | Radiopaque – Contains hydroxyapatite, ß-tricalcium phosphate and barium sulfate | | Composition | Sterile mixture of two separate components of paste-like consistency comprised of granular calcium phosphate, (hydroxyapatite and β- tricalcium phosphate), calcium stearate, vitamin E acetate, triacetin, 1,4- butanediol, triethanolamine and a mixture of a lactide-diester and polyester-based (lactide and caprolactone) absorbable polymers. HBP6 is to be mixed immediately prior to use. Resulting settable device from the two pastes is primarily comprised of calcium phosphate similar to the mineral phase of native bone tissue. | Sterile mixture of two separate components of paste-like consistency comprised of granular calcium phosphate, (hydroxyapatite and ß-tricalcium phosphate), calcium stearate, vitamin E acetate, triacetin, 1,4- butanediol, triethanolamine, a mixture of a lactide-diester and polyester-based (lactide and caprolactone) absorbable polymers and barium sulfate. Montage Flowable XRO is to be mixed immediately prior to use. Resulting settable device from the two pastes is primarily comprised of calcium phosphate similar to the mineral phase of native bone tissue. | | Resorbable | Yes | Yes | | | | | | Resorption Time | Greater than 30 days primarily due to presence of calcium phosphate. | Greater than 30 days primarily due to presence of calcium phosphate | | Method of Application | Manually applied with delivery instrument and spread onto bone tissue | Manually applied with delivery instrument and spread onto bone tissue | | Degradation Process | The non-calcium salt and non- polymeric components degrade via dissolution; the polymer degrades via hydrolysis and calcium salts degrade via chemical dissolution and/or cellular removal | The non-calcium salt and non- polymeric components degrade via dissolution; the polymer degrades via hydrolysis and the calcium salts and barium sulfate degrade via chemical dissolution and/or cellular removal | | Sterility | Provided sterile for single use by gamma irradiation | Provided sterile for single use by gamma irradiation | | MRI Safety | Device is safe in the MRI environment | Device is safe in the MRI environment | #### Predicate Comparison Table {5}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------ ## Performance Testing: Bench testing, biocompatibility and animal functionality testing performed on the predicate and Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste demonstrate that the device is substantially equivalent to predicate devices in intended use, technological characteristics, and performance. This testing included the following: Bench Testing was conducted to verify the device's handling properties, to characterize the device's performance over a range of temperatures and to evaluate the device's dissolution properties. The following evaluations were completed: relative stiffness, spreadability, stickiness, temperature sensitivity, electrocautery compatibility, dissolution and swelling. Biocompatibility 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-irradiated sterile device in accordance with the GLP requirements: irritation, sensitization, acute systemic toxicity, genotoxicity, implantation, systemic toxicity, hemolysis, endotoxicity and pyrogenicity. Animal Testing included studies to demonstrate intraoperative in vivo hemostasis and resistance to irrigation. #### Sterilitv The gamma sterilization process has been validated to provide a SAL of 10-6. Each lot of finished devices is tested for bacterial endotoxin for lot release. #### Conclusion Montage Flowable XRO is substantially equivalent to the predicate HBP6 Settable Hemostatic Bone Putty and previously cleared bone hemostasis devices with respect to intended use, general technological characteristics and performance.