Orthocon MONTAGE Flowable Settable, Resorbable Bone Paste is indicated to fill bony voids or gaps in the skeletal system (i.e., extremities and pelvis). These defects may be surgically created or osseous defects created as the result of traumatic injury to the bone. Montage Flowable is indicated only for filling bony voids or gaps that are not intrinsic to the integrity of the bony structure.

When hardened in situ, Montage Flowable may be used to augment provisional hardware (e.g., k-wires, plates and screws) and to help support bone fragments during the surgical procedure. The hardened paste acts only as a temporary support medium and is not intended to provide structural support during the healing process.

Montage Flowable can be drilled and tapped, and hardware can be placed through it at any time during the setting process.

Device Description

AI/ML Overview

The provided document is a 510(k) Summary for a medical device (Montage Flowable Settable, Resorbable Bone Paste) and does not describe acceptance criteria for a study proving the device meets those criteria in the context of an AI/ML or diagnostic device. The document primarily focuses on establishing substantial equivalence to a predicate device based on material composition, intended use, and performance in an animal model.

Therefore, many of the specific questions regarding acceptance criteria for a test set, sample sizes for test and training sets, expert qualifications, ground truth establishment, MRMC studies, and standalone algorithm performance cannot be answered from the provided text.

However, I can extract information related to the device performance testing that was done:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present "acceptance criteria" in a table format for performance, but it provides performance data from an animal study and states tests conducted.

Aspect Tested	Acceptance Criteria (Implicit)	Reported Device Performance
New Bone Formation (at 12 weeks in rabbit model)	Not explicitly stated as an acceptance criterion value, but the goal is to demonstrate performance comparable or superior to the predicate and better than an empty defect control, supporting the claim of filling bony voids and subsequent bone replacement.	Montage Flowable: 15.8% new bone formationHydroSet (Predicate): 12.4% new bone formationEmpty Defect (Negative Control): 10% new bone formationNote: "Clinical performance has not been evaluated."
Device Resorption (at 12 weeks in rabbit model)	Not explicitly stated as an acceptance criterion value, but the goal is to demonstrate resorbability as intended for a resorbable bone paste.	Approximately 75% of implant material remained in both the Montage Flowable group and the HydroSet group at 12 weeks.
Drillability/Temporary Support	Device can be drilled when hardened without fragmenting or being displaced. Provides temporary support to a complex repair until permanent hardware fixation is accomplished. (Implicit acceptance: no fragmentation/displacement, successful temporary support).	"Testing was conducted to verify that the device may be drilled when hardened without fragmenting or being displaced. This allows use in conjunction with provisional hardware. In addition, an in vitro study was conducted to demonstrate that once placed as indicated, the device provides temporary support to a complex repair until permanent hardware fixation is accomplished." (Results stated as successful verification/demonstration).
Material Settability/Hardening Time	Consistent with predicate (material settable within 10 minutes of application).	Material is settable within 10 minutes of application.
Absence of Appreciable Exothermic Reaction during Curing	No appreciable exothermic reaction.	Device cures with no appreciable exothermic reaction.
Biocompatibility	Meet recommendations of ISO 10993 (Cytotoxicity, irritation, sensitization, systemic toxicity, genotoxicity, local tissue toxicity, hemolysis, endotoxicity, pyrogenicity).	"Testing was conducted to evaluate the device's biocompatibility in accordance with the recommendations of ISO 10993." (Implied successful completion and meeting standards).
Sterility	SAL of 10^-6; each lot tested for bacterial endotoxin.	"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."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size (Animal Study): The document mentions a "rabbit critical sized femoral defect model," implying an animal group size, but the specific number is not provided. It refers to "Montage Flowable group," "HydroSet predicate group," and "empty defect negative control group."
Data Provenance: Not specified (e.g., country of origin). The study described is an animal study, not human clinical data, and appears to be prospective in its design (creating defects and implanting materials to observe outcomes).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the study described is an animal study, not an AI/ML or diagnostic study requiring human expert ground truth for imaging interpretation. Ground truth for the animal study (new bone formation, device resorption) was established through objective measurements via micro-CT and histopathology/histomorphometry.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This is not a human reader study or AI/ML study requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This document describes the performance of a physical medical device (bone paste), not an AI/ML algorithm or diagnostic system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This document describes the performance of a physical medical device (bone paste), not an AI/ML algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For the animal study:

Micro-CT for quantitative assessment.
Histopathology/Histomorphometry for quantitative assessment of new bone formation and device resorption.

8. The sample size for the training set

Not applicable. There is no training set mentioned or used as this is not an AI/ML device.

9. How the ground truth for the training set was established

Not applicable. There is no training set mentioned or used as this is not an AI/ML device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows 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.

September 1, 2023

Orthocon, Inc. Howard Schrayer Consultant 8 Lookout Hilton Head Island, South Carolina 29928

Re: K231270

Trade/Device Name: Montage Flowable Settable, Resorbable Bone Paste Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable Calcium Salt Bone Void Filler Device Regulatory Class: Class II Product Code: MOV. OIS Dated: August 3, 2023 Received: August 3, 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

{1}------------------------------------------------

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 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 medical devices and radiation-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,

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) K231270

Device Name

Montage Flowable Settable, Resorbable Bone Paste

Indications for Use (Describe)

Montage Flowable can be drilled and tapped, and hardware can be placed through it at any time during the setting process.

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

General Company Information

Name:	Orthocon, Inc.
Contact:	Howard SchrayerRegulatory Affairs Consultant
Address:	700 Fairfield Avenue – Suite 1Stamford, CT 06902
Telephone:	(609) 273 - 7350
Date Prepared	July 11, 2023

General Device Information

Product Name:	Montage Flowable Settable, Resorbable Bone Paste
---------------	--------------------------------------------------

Common Name: Resorbable calcium salt bone void filler device

Classification:	Class II
Product code:	MQV, OIS
Regulation:	21 CFR 888.3045

Predicate Devices

Primary Predicate:

Orthovita, Inc.	HydroSet XT™
	[510(k) Number K161447]

Reference Device:

Orthocon, Inc. HBP6, Resorbable Hemostatic Bone Paste [510(k) Number K193052]
Orthocon, Inc. Montage-QS Settable, Resorbable Bone Putty [510(k) Number K191140]

{4}------------------------------------------------

Description

Montage Flowable Settable. Resorbable Bone Paste is a sterile. biocompatible, resorbable material for use in filling bony voids or gaps in skeletal bones of the extremities. The Montage Flowable device comprises two separate components of paste-like consistency containing granular calcium phosphate, calcium stearate, vitamin E acetate, a triglyceride, polyalcohols and a mixture of a lactide-diester and polyester-based polymers. When mixed together in the applicator tip, the components of the Montage Flowable device form a cohesive paste-like material that adheres to the bone surface and remains in place following application. The resulting hardened, resorbable material is primarily calcium phosphate and is slowly resorbed and replaced with bone during the remodeling process. Montage Flowable can be drilled and tapped, and hardware can be placed through it at any time during the setting process. The performance of Montage Flowable was compared to HydroSet in a rabbit critical sized femoral defect model. At the 12-week timepoint, animal study data demonstrated new bone formation averages of 15.8% in the Montage Flowable group, 12.4% in the HydroSet predicate group, and 10% in the empty defect negative control group. Animal study data suggest that approximately 75% of implant material remained in both the Montage Flowable group and the HydroSet group at 12 weeks following implantation.

Intended Use (Indications)

Montage Flowable can be drilled and tapped, and hardware can be placed through it at any time during the setting process.

Purpose of Submission

Orthocon is proposing to modify the labeling (Instructions for Use) to provide for use of Montage Flowable as a bone void filler that can be used to augment provisional hardware (e.g., k-wires, plates and screws) and to help support bone fragments during the surgical procedure.

{5}------------------------------------------------

Substantial Equivalence

This submission supports the position that Orthocon Montage Flowable Settable, Resorbable Bone Paste is substantially equivalent to the HydroSet XT primary predicate 510(k) - K161447.

The following table shows comparisons of the several characteristics of Montage Flowable Settable, Resorbable Bone Paste and the primary predicate device. The differences noted in the table below do not impact substantial equivalence.

SUBSTANTIAL EQUIVALENCE INFORMATION

Orthocon, Inc. Montage Flowable Settable, Resorbable Bone Paste

Orthovita / Stryker HydroSet XT™ Bone Void Filler

TBD

510(k) - K161447

Similarities and Differences

Device is indicated for use as a bonegraft substitute to fill voids in damagedbone that are not intrinsic to the stabilityof the bony structure.	Device is indicated for use as a bonegraft substitute to fill voids in damagedbone that are not intrinsic to the stabilityof the bony structure.
Hardened device can be drilled andtapped to provide temporary support forthe placement of provisional hardwareduring the surgical procedure.	Hardened device can provide temporarysupport for the placement of provisionalhardware during the surgical procedure.
At the time of application, device is inthe form of a paste-like material	At the time of application, device is inthe form of a paste-like material
Device is designed to be manuallyapplied or injected with a syringe andspread onto voids in bone tissue	Device is designed to be manuallyapplied or injected with a syringe andspread onto voids in bone tissue
Montage Flowable Settable, ResorbableBone Paste is formulated as a two-partpaste/paste device that forms a"settable" (hardening) material whenmixed at the time of surgery	HydroSet XT settable, resorbable bonevoid filler device is formulated as a two-part powder/liquid device that forms a"settable" (hardening) material whenmanually mixed at the time of surgery
Sterile mixture of two separatecomponents of paste-like consistencycomprised of granular calciumphosphate, (hydroxyapatite and β-tricalcium phosphate), calcium stearate,vitamin E acetate, a triglyceride,polyalcohols and a mixture of a lactide-	Sterile mixture of two separatecomponents, a powder comprised ofdicalcium phosphate dihydrate,tetracalcium phosphate and tri-sodiumcitrate; and a liquid comprised ofsodium phosphate, polyvinylpyrrolidoneand water. HydroSet XT is to be

{6}------------------------------------------------

diester and polyester-based polymers.Montage Flowable is mixed in a staticmixing tip immediately prior to use.Resulting settable material from the twopastes is primarily comprised of calciumphosphate similar to the mineral phaseof native bone tissue.	manually mixed immediately prior touse. Resulting settable material fromthe two components is primarilycomprised of calcium phosphate similarto the mineral phase of native bonetissue.
Implanted device is resorbable ingreater than 30 days primarily due topresence of calcium phosphate.	Implanted device is resorbable ingreater than 30 days primarily due topresence of calcium phosphate.
The non-calcium salt and non-polymericcomponents degrade via dissolution; thepolymer degrades via hydrolysis andcalcium salts degrade via chemicaldissolution and/or cellular removal	The non-calcium salt componentsdegrade via dissolution and calciumsalts degrade via chemical dissolutionand/or cellular removal
Single-patient-use device is providedsterile by gamma irradiation	Single-patient-use device is providedsterile by gamma irradiation andethylene oxide
The device is available for single-patientuse with a single-use applicator.	The device is available for single-patientuse with a single-use applicator.
The paste is provided in a dual-barrelcartridge within a single outer foil pouch.The outer foil pouch contains adesiccant. The pouch is heat sealedand sterilized.	Each kit contains one liquid-filled glasssyringe and one plastic bowl of powderpackaged within a double pre-formedtray with a Tyvek lid.
Mixing for homogeneity is immediate.	Mixing for homogeneity takes 45 sec.
Material is settable within 10 minutes ofapplication	Material is settable within 10 minutes ofapplication
Device cures with no appreciableexothermic reaction.	Device cures with no appreciableexothermic reaction

Testing Completed

Performance Animal Testing

The performance of Montage Flowable was compared to HydroSet in a rabbit critical sized femoral defect model. Micro-CT and histopathology/histomorphometry assessments were performed on defects treated with each material to quantify device resorption and new bone formation. At the 12-week timepoint, animal study data demonstrated new bone formation averages of 15.8% in the Montage Flowable group, 12.4% in the HydroSet predicate group, and 10% in the empty defect negative control group. Clinical performance has not been evaluated.

{7}------------------------------------------------

Performance Data

Testing was conducted to verify that the device may be drilled when hardened without fragmenting or being displaced. This allows use in conjunction with provisional hardware. In addition, an in vitro study was conducted to demonstrate that once placed as indicated, the device provides temporary support to a complex repair until permanent hardware fixation is accomplished.

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, sensitization, systemic toxicity, genotoxicity, local tissue toxicity, hemolysis, endotoxicity and pyrogenicity.

Sterility

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.

Conclusions

The information provided establishes that the Orthocon Montage Flowable Settable, Resorbable Bone Paste performs substantially equivalent to the HydroSet predicate device for the same intended use. All results demonstrate that any differences in technology do not impact substantial equivalence.

Regulation Number and Section

§ 888.3045 Resorbable calcium salt bone void filler device.

(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.