Orthocon Montage-XT Settable, Resorbable Bone Putty 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-XT 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-XT 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 putty acts only as a temporary support medium and is not intended to provide structural support during the healing process.

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

Device Description

Montage-XT Settable, Resorbable Bone Putty is a sterile, biocompatible, resorbable material for use in filling bony voids or gaps in skeletal bones of the extremities. The single use Montage-XT device contains two separate components of putty-like consistency containing granular calcium phosphate, calcium stearate, vitamin E acetate, a triglyceride, a polyalcohol and a mixture of a lactide-diester and polyesterbased polymers. When mixed together, the components of Montage-XT form a cohesive putty-like material that adheres to the bone surface and remains in place following application. The resulting hardened material is primarily calcium phosphate. Montage-XT can be drilled and tapped, and hardware can be placed through it at any time during the setting process.

Montage-XT differs from Montage by allowing for an extended working time of up to 4 minutes.

AI/ML Overview

The provided FDA 510(k) summary does not describe an AI/ML device. Instead, it concerns a medical device called "Montage-XT Settable, Resorbable Bone Putty." Therefore, the requested information pertaining to acceptance criteria and studies demonstrating AI device performance (such as sample sizes for test and training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance) is not applicable to this document.

The document discusses the substantial equivalence of Montage-XT to a predicate device (Montage Settable, Resorbable Bone Putty) based on non-AI performance testing. Here's a breakdown of the relevant information provided:

Acceptance Criteria and Reported Device Performance (Non-AI Device)

Given that this is not an AI device, there are no specific "acceptance criteria" in terms of algorithm performance metrics (e.g., sensitivity, specificity, AUC). Instead, the performance is evaluated through bench testing, biocompatibility testing, and animal testing to demonstrate substantial equivalence to a predicate device.

Table of Performance Comparisons for Substantial Equivalence:

Characteristic	Acceptance Criteria (Implied by Predicate Device)	Reported Device Performance (Montage-XT)
Indications for Use	To fill bony voids or gaps in the skeletal system (extremities and pelvis); surgically created or traumatic osseous defects. Not for defects intrinsic to bony structure integrity. Can augment provisional hardware and support bone fragments during surgery (temporary support). Can be drilled and tapped; hardware placed through it at any time during setting.	Identical to predicate device (Montage). This submission adds "bone void filler device" indication to Montage-XT, aligning it with Montage.
Formulation	Sterile, biocompatible, resorbable material (granular calcium phosphate, calcium stearate, vitamin E acetate, triglyceride, polyalcohol, lactide-diester and polyester-based polymers). Two separate components.	Nearly identical. The document states that the devices have "nearly identical formulations" and Montage-XT contains the same components as Montage described in the device description.
Application Method	Manually applied and spread onto bone defects. Putty-like material at application.	Identical. Manually applied and spread onto bone defects. Putty-like material at application.
Setting Mechanism	Two-part putty/putty device that forms a "settable" (hardening) material when mixed at the time of surgery. Primarily comprised of calcium phosphate similar to native bone.	Identical. Same setting mechanism and primary composition.
Resorption Time	Implanted device is resorbable in greater than 30 days primarily due to presence of calcium phosphate.	Identical. Resorbable in greater than 30 days. Animal study data showed approximately 70% implant material remaining at 12 weeks for both Montage-XT and Montage.
Degradation	Non-calcium salt and non-polymeric components degrade via dissolution; polymer degrades via hydrolysis; calcium salts degrade via chemical dissolution and/or cellular removal.	Identical degradation mechanisms.
Sterilization	Sterile by gamma irradiation.	Identical. Sterilized by the same validated gamma irradiation process.
Packaging	Two putties separately within a single outer foil pouch, with a desiccant.	Identical. Same packaging.
Mixing for Homogeneity	45 seconds.	Identical. 45 seconds.
Working Time	2 minutes (for Montage).	4 minutes (for Montage-XT). This is identified as the only clinically meaningful difference.
Exothermic Reaction	Cures with no appreciable exothermic reaction.	Identical. Cures with no appreciable exothermic reaction.
Drillability/Tappability	Can be drilled and tapped; hardware can be placed through it at any time during setting process.	Identical. Can be drilled and tapped; hardware can be placed through it at any time during setting process.
New Bone Formation	Adequate new bone formation to demonstrate efficacy as a bone void filler (implied by predicate clearance).	20.4% new bone formation in Montage-XT group at 12 weeks, compared to 20.8% in Montage predicate group, and <10% in empty defect control.

Study Information (for Non-AI Device)

Sample size used for the test set and the data provenance:
- Bench Testing: No specific numerical sample sizes are given for each bench test (pH, dissolution/solubility, reaction temperature, relative stiffness, spreadability, stickiness, temperature sensitivity, electrocautery compatibility, working time). These are typically "n=" numbers for in-vitro experiments.
- Biocompatibility Testing: Not specified in terms of sample size, but indicates a battery of tests (irritation, sensitization, acute systemic toxicity, genotoxicity, implantation, systemic toxicity, hemolysis, endotoxicity, pyrogenicity) conducted in accordance with GLP requirements.
- Animal Testing: A "rabbit critical sized femoral defect model" was used. The number of animals in the Montage-XT group and Montage predicate group is not specified, but the results (20.4% vs 20.8% new bone formation) suggest multiple animals per group. The study was prospective in nature, comparing Montage-XT to Montage and an empty control. The country of origin for the animals and study is not explicitly stated.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is not an AI device, so there's no ground truth established by experts in the context of diagnostic interpretation. Ground truth for animal studies would be based on histological analysis by veterinary pathologists.
Adjudication method for the test set: Not applicable for an AI context. For the animal study, the "ground truth" (new bone formation, material remaining) would be determined by quantitative histological or imaging analysis, likely reviewed by experienced individuals, but not an adjudication process in the sense of expert consensus on image interpretation.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, a multi-reader multi-case study is not applicable for this type of medical device (bone putty).
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI algorithm.
The type of ground truth used:
- Bench Testing: Physical, chemical, and mechanical measurements and observations.
- Biocompatibility Testing: Biological responses in animal models or in-vitro systems according to ISO 10993.
- Animal Testing: Histological analysis and potentially imaging (e.g., radiography, micro-CT) to quantify new bone formation and material resorption in vivo.
The sample size for the training set: Not applicable. There is no training set for a physical medical device.
How the ground truth for the training set was established: Not applicable.

Summary of the Device's Approval Justification:

The device (Montage-XT) received 510(k) clearance because it was determined to be substantially equivalent to a legally marketed predicate device (Montage). The primary justification is that Montage-XT is "nearly identical" to Montage in its composition, intended use, technological characteristics, and performance, with the only clinically meaningful difference being an extended working time from 2 to 4 minutes. This extended working time, along with the new bone formation and resorption characteristics, was demonstrated as equivalent to the predicate device in an animal study. The submission also adds "bone void filler" as an indication for Montage-XT, consistent with the predicate device.

Summary

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August 21, 2024

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 is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Orthocon, Inc. Howard Schrayer Regulatory Consultant 700 Fairfield Ave. - Suite 1 Stamford, Connecticut 06902

Re: K233566

Trade/Device Name: Montage-XT Settable, Resorbable Bone Putty Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable Calcium Salt Bone Void Filler Device Regulatory Class: Class II Product Code: MQV, OIS Dated: July 3, 2024 Received: July 3, 2024

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).

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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 OS 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, JESSE MUIR Digitally signed by JESSE
MUIR-S Date: 2024.08.21 -2 10:28:43 -04'00' 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

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K233566 - Howard Schrayer

Enclosure

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Indications for Use

Submission Number (if known)

K233566

Device Name

Montage-XT Settable, Resorbable Bone Putty

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

ver-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary K233566

Contact:	Howard SchrayerOrthocon, Inc.8 LookoutHilton Head Island, SC 29928Telephone: 609-273-7350hs.ss@lucidmedical.net
Date Prepared:	August 20, 2024
Device Trade Name:	MONTAGE-XT™ Settable, Resorbable Bone Putty
Manufacturer:	Orthocon, Inc.700 Fairfield Avenue, Suite 1Stamford, CT 10533
Telephone:	(855) 475 - 9175
Common Name:	Resorbable calcium salt bone void filler device
Classification:	Class II
Product Code:	MQV, OIS
Primary Predicate Device:

MONTAGE® Settable, Resorbable Bone Putty Orthocon, Inc. 510(k) K222063

Reference Predicate Device:

MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty Orthocon, Inc. 510(k) K220315

Indications for Use:

When hardened in situ. Montage-XT may be used to augment provisional hardware (e.g., k-wires, plates and screws) and to help support bone fragments during the

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surqical procedure. The hardened putty acts only as a temporary support medium and is not intended to provide structural support during the healing process.

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

Device Description:

Montage-XT differs from Montage by allowing for an extended working time of up to 4 minutes. The performance of Montage-XT was compared to Montage in a rabbit critical sized femoral defect model. At the 12-week timepoint, animal study data demonstrated new bone formation averages of 20.4% in the Montage-XT group, 20.8% in the Montage predicate group, and less than 10% in the empty defect negative control group. Animal study data show that approximately 70% of implant material remained in both the Montage-XT group and the Montage group at 12 weeks following implantation.

Purpose of this Submission:

Montage-XT was previously cleared for use in the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade. The purpose of this submission is to add an indication for Montage-XT for use as a bone void filler device.

Substantial Equivalence and Predicate Devices:

The subject device is nearly identical to and is substantially equivalent to its previously cleared primary predicate, Montage. The only difference between the subject device and its reference predicate is the addition of a statement regarding the use of the device as a bone void filler.

The following table shows comparisons of the several characteristics of Montage-XT and the primary predicate device. The differences noted in the table below do not impact substantial equivalence.

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SUBSTANTIAL EQUIVALENCE INFORMATION

Orthocon, Inc. Montage-XT Settable, Resorbable Bone Putty

Orthocon, Inc. Montage Settable, Resorbable Bone Putty

510(k) - 233566

510(k) - K222063

Similarities and Differences

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Technoloqical Characteristics:

The technological characteristics of the devices are unchanged. The only change is the addition of a statement regarding the use of Montage-XT in as a bone void filler.

Performance Testing:

The only clinically meaningful difference between Montage and Montaqe-XT is the extension of working time from 2 to 4 minutes. Evaluations were previously conducted to compare MONTAGE-XT Settable, Resorbable Bone Putty with the predicate device. The evaluations demonstrated that Montage-XT is substantially equivalent to the Montage predicate 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. The following bench studies were completed: pH characterization, dissolution/solubility, reaction temperature, relative stiffness, spreadability, stickiness, temperature sensitivity, electrocautery compatibility and working time. Both devices are sterilized with the same validated gamma irradiation process and both have the same established shelf-life / stability characteristics.

Biocompatibility Testing was conducted to evaluate biocompatibility in accordance with the recommendations of ISO 10993. The following biocompatibility studies were conducted in accordance with the GLP requirements: irritation, sensitization, acute systemic toxicity, genotoxicity, implantation, systemic toxicity, hemolysis, endotoxicity and pyrogenicity.

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Animal Testing included animal studies to quantify device resorption and new bone formation of Montage and Montage-XT in a rabbit critical sized femoral defect model. Because the devices have nearly identical formulations and have been found to be substantially equivalent in all other respects, the data supporting use as a bone void filler from studies of Montage is relevant to Montage-XT and was confirmed through testing of Montage-XT. Clinical performance has not been evaluated.

Conclusion

MONTAGE-XT is substantially equivalent to Montage Settable, Resorbable Bone Putty with respect to intended use, general technological characteristics, and performance.

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.

Orthocon Montage-XT Settable,	Orthocon Montage Settable,
Resorbable Bone Putty is indicated to	Resorbable Bone Putty is indicated to
fill bony voids or gaps in the skeletal	fill bony voids or gaps in the skeletal
system (i.e., extremities and pelvis).	system (i.e., extremities and pelvis).
These defects may be surgically	These defects may be surgically
created, or osseous defects created	created, or osseous defects created
as the result of traumatic injury to the	as the result of traumatic injury to the
bone. Montage-XT is indicated only	bone. Montage is indicated only for
for filling bony voids or gaps that are	filling bony voids or gaps that are not
not intrinsic to the integrity of the bony	intrinsic to the integrity of the bony
structure.	structure.
When hardened in situ, Montage-XT	When hardened in situ, Montage may
may be used to augment provisional	be used to augment provisional
hardware (e.g., k-wires, plates and	hardware (e.g., k-wires, plates and
screws) and to help support bone	screws) and to help support bone
fragments during the surgical	fragments during the surgical
procedure. The hardened putty acts	procedure. The hardened putty acts
only as a temporary support medium	only as a temporary support medium
and is not intended to provide	and is not intended to provide
structural support during the healing	structural support during the healing
process.	process.
Montage-XT can be drilled andtapped, and hardware can be placedthrough it at any time during thesetting process.	Montage can be drilled and tapped,and hardware can be placed through itat any time during the setting process.

At the time of application, device is in	At the time of application, device is in
the form of a putty-like material	the form of a putty-like material

Device is designed to be manually	Device is designed to be manually
applied and spread onto bone defects	applied and spread onto bone defects

Montage-XT Settable, ResorbableBone Putty is formulated as a two-part putty/putty device that forms a"settable" (hardening) material whenmixed at the time of surgery	Montage-XT Settable, Bone Putty isformulated as a two-part putty/puttydevice that forms a "settable"(hardening) material when mixed atthe time of surgery
Sterile mixture of two separate	Sterile mixture of two separate
components of putty-like consistencycomprised of granular calciumphosphate, (hydroxyapatite and ß-tricalcium phosphate), calciumstearate, vitamin E acetate, atriglyceride, a polyalcohol and amixture of a lactide-diester andpolyester-based (lactide andcaprolactone) absorbable polymers.Montage-XT is to be mixedimmediately prior to use. Resultingsettable material from the two puttiesis primarily comprised of calciumphosphate similar to the mineral	components of putty-like consistencycomprised of granular calciumphosphate, (hydroxyapatite and ß-tricalcium phosphate), calciumstearate, vitamin E acetate, atriglyceride, a polyalcohol and amixture of a lactide-diester andpolyester-based (lactide andcaprolactone) absorbable polymers.Montage is to be mixed immediatelyprior to use. Resulting settablematerial from the two putties isprimarily comprised of calciumphosphate similar to the mineral
phase of native bone tissue.	phase of native bone tissue.
Implanted device is resorbable in	Implanted device is resorbable in
greater than 30 days primarily due topresence of calcium phosphate.	greater than 30 days primarily due topresence of calcium phosphate.

The non-calcium salt and non-polymeric components degrade viadissolution; the polymer degrades viahydrolysis and calcium salts degradevia chemical dissolution and/orcellular removal	The non-calcium salt and non-polymeric components degrade viadissolution; the polymer degrades viahydrolysis and calcium salts degradevia chemical dissolution and/or cellularremoval

Single-patient-use device is providedsterile by gamma irradiation	Single-patient-use device is providedsterile by gamma irradiation
The two putties are provided	The two putties are provided
separately within a single outer foilpouch. The outer foil pouch containsa desiccant.	separately within a single outer foilpouch. The outer foil pouch containsa desiccant.
Mixing for homogeneity takes 45 sec.	Mixing for homogeneity takes 45 sec.
Working time is 4 minutes
	Working time is 2 minutes
Device cures with no appreciable	Device cures with no appreciable
exothermic reaction.	exothermic reaction
Device can be drilled and tapped, and	Device can be drilled and tapped, and
hardware can be placed through it at	hardware can be placed through it at
any time during the setting process.	any time during the setting process.
When hardened in situ, Montage-XT	When hardened in situ, Montage-XT may
may be used to augment provisional	be used to augment provisional
hardware (e.g., k-wires, plates and	hardware (e.g., k-wires, plates and
screws) and to help support bone	screws) and to help support bone
fragments during the surgical	fragments during the surgical
procedure. The hardened putty acts	procedure. The hardened putty acts
only as a temporary support medium	only as a temporary support medium
and is not intended to provide	and is not intended to provide
structural support during the healing	structural support during the healing
process.	process.