Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a bone putty material and its physical and biological properties. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI/ML.

Therapeutic

Yes
The device is used for the repair of cranial defects, which indicates a therapeutic purpose to treat a medical condition.

Diagnostic

No

Explanation: This device is a bone putty used to repair cranial defects, not to diagnose medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical material (putty) composed of various chemical components, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for the repair of neurosurgical burr holes and cranial defects. This is a surgical procedure involving the direct application of a material to the body.
Device Description: The device is a bone putty, a material intended to be implanted or applied to bone tissue.
Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a condition, analyze a sample from the body, or provide information about a patient's health status based on in vitro testing.
Testing: The performance studies focus on biocompatibility, bench testing of material properties, and in-vivo animal testing for bone repair. These are typical tests for implantable or surgical materials, not IVDs.

IVDs are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Orthocon MONTAGE Settable, Resorbable 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 Settable, Resorbable Bone Putty should be used only in skeletally mature individuals.

Product codes

GXP

Device Description

MONTAGE Settable, Resorbable Bone Putty is a sterile, biocompatible, resorbable material for use in repair of cranial defects. The MONTAGE device comprises two separate components of putty consistency containing granular calcium phosphate, calcium stearate, a triglyceride, a polyalcohol and a mixture of a lactide-diester and polyester-based polymers. When mixed together, the components of the MONTAGE device form a putty-like material. The resulting hardened, resorbable material is primarily calcium phosphate. MONTAGE components must be mixed immediately prior to use.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

cranial defects, neurosurgical burr holes

Indicated Patient Age Range

skeletally mature individuals

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

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, pyrogenicity and neurotoxicity.

Bench Testing:

Visual Inspection: Evaluated putty component color using a 3-point scale. Conclusions: Putty color and handling met specification.
Putty Handling: Evaluated putty stickiness to gloves using a 3-point scale. Conclusions: Putty color and handling met specification.
Putty Stiffness: Measured putty stiffness using a Penetrometer. Conclusions: Putty stiffness met specification.
Putty Vitamin E Acetate Concentration: Solvent extraction and chemical analysis. Conclusions: Putty vitamin E acetate concentration met specification.
Hand Mixing Time: Evaluated hand-mixing time using a 2-point scale. Conclusions: Mixing time, stickiness, and mixability met specification.
Hand Mixing Stickiness: Evaluated stickiness to gloves using a 3-point scale. Conclusions: Mixing time, stickiness, and mixability met specification.
Mixability: Evaluated mixability using a 2-point scale. Conclusions: Mixing time, stickiness, and mixability met specification.
Device Stiffness: Measured device stiffness using a Penetrometer. Conclusions: Device stiffness met specification.
Package Gross Leak: Bubble emission leak test. Conclusions: All test articles passed.
Temperature Sensitivity: Determined maximum temperature increase observed during mixing. Conclusions: Acceptable maximum temperature increase following hand-mixing.
Water Uptake, Swelling and Dissolution: Measured volume and mass changes during 72 hours in phosphate buffered saline, pH 7.4, at 37°C. Conclusions: Acceptable water uptake, swelling and dissolution.

In-Vivo Testing: In-vivo animal testing was used to demonstrate substantial equivalence of MONTAGE Settable, Resorbable Bone Putty in the repair of a critical sized cranial bone defect of New Zealand White rabbits compared to the predicate device. Substantial equivalence was assessed from histopathologic evaluation and histomorphometric measurements of implant absorption over time.

Clinical Testing: No clinical studies have been conducted in support of this 510(k).

Key Metrics

Not Found

Predicate Device(s)

K060763

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 882.5300 Methyl methacrylate for cranioplasty.

(a)
Identification. Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect.(b)
Classification. Class II (performance standards).

Summary

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Image /page/0/Picture/0 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 acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.

January 13, 2023

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

Re: K221933

Trade/Device Name: MONTAGE Settable, Resorbable Bone Putty Regulation Number: 21 CFR 882.5300 Regulation Name: Methyl Methacrylate For Cranioplasty Regulatory Class: Class II Product Code: GXP Dated: December 14, 2022 Received: December 14, 2022

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

1

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.

Image /page/1/Picture/5 description: The image shows the text "Adam D." on the first line and "Pierce -S" on the second line. The text is black and the background is a light blue and white grid pattern. The text is large and easy to read.

Digitally signed by Adam D. Pierce -S Date: 2023.01.13 13:22:26 -05'00'

Adam 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 Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K221933

Device Name

MONTAGE Settable, Resorbable Bone Putty

Indications for Use (Describe)

Orthocon MONTAGE Settable, Resorbable 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 Settable, Resorbable Bone Putty should be used only in skeletally mature individuals.

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

Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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General Company Information

Name:	Orthocon, Inc.
Address:	700 Fairfield Avenue, Suite 1
Stamford, CT 06902
Telephone:	(855) 475 - 9175
Contact:	Howard Schrayer
Date Prepared	January 12, 2023

General Device Information

Product Name:	MONTAGE Settable, Resorbable Bone Putty
Common Name:	Calcium Phosphate Cement
Classification:	Class II
Product codes:	GXP
Regulation:	21 CFR 882.5300

Predicate Device

Stryker	Stryker Injectable Cement
	[510(k) Number K060763]

Device Description

MONTAGE Settable, Resorbable Bone Putty is a sterile, biocompatible, resorbable material for use in repair of cranial defects. The MONTAGE device comprises two separate components of putty consistency containing granular calcium phosphate, calcium stearate, a triglyceride, a polyalcohol and a mixture of a lactide-diester and polyester-based polymers. When mixed together, the components of the MONTAGE device form a putty-like material. The resulting hardened, resorbable material is primarily calcium phosphate. MONTAGE components must be mixed immediately prior to use.

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Indications for Use

Orthocon MONTAGE 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 Settable, Resorbable Bone Putty should be used only in skeletally mature individuals.

The following table shows comparisons of characteristics of MONTAGE Settable, Resorbable Bone Putty and the predicate device.

SUBSTANTIAL EQUIVALENCE INFORMATION

Orthocon, Inc. MONTAGE Settable. Resorbable Bone Putty 510(k) - 221933

Stryker Injectable Cement HydroSet

510(k) - K060763

Comparisons of Technological Characteristics

| Device is intended for use in the repair of
neurosurgical burr holes, contiguous
craniotomy cuts and other cranial defects
with a surface area no larger than 25cm². | Stryker Injectable Cement is intended for use in
the repair of neurosurgical burr holes,
contiguous craniotomy cuts and other cranial defects. |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| At the time of application, device is in the
form of a putty-like material | At the time of application, device is in the form
of a paste-like material |
| Device is designed to be manually applied to
the cranial defect | Device is designed to be manually applied to
the cranial defect |
| MONTAGE Settable, Resorbable Bone
Putty is formulated as a two-part putty/putty
device that forms a “settable” (hardening)
material when manually mixed at the time of
surgery | Stryker Injectable cement is formulated as a
two-part powder/liquid device that forms a
"settable" (hardening) material when manually
mixed at the time of surgery |
| Sterile mixture of two separate components
of putty-like consistency comprised of
granular calcium phosphate,
(hydroxyapatite and β-tricalcium
phosphate), calcium stearate, vitamin E
acetate, triacetin, 1,4-butanediol and a
mixture of a lactide-diester and polyester-
based (lactide and caprolactone)
absorbable polymers. MONTAGE is to be
mixed immediately prior to use. Resulting
settable material from the two putties is
primarily comprised of calcium phosphate | Sterile mixture of two separate components, a
powder comprised of dicalcium phosphate
dihydrate, tetracalcium phosphate and tri-
sodium citrate; and a liquid comprised of
sodium phosphate, polyvinylpyrrolidone and
water. Stryker Injectable Cement is to be
manually mixed immediately prior to use.
Resulting settable material from the two
components is primarily comprised of calcium
phosphate. |

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| Implanted device is resorbable in
greater than 30 days primarily due to
presence of calcium phosphate. | Implanted device is resorbable in greater
than 30 days primarily due to presence of
calcium phosphate. |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 45 sec. | Mixing for homogeneity takes 45 sec. |
| Material is settable within 10 minutes of
application | Material is settable within 10 minutes of
application |
| Material provides a working time of 2
minutes. | Material provides a working time of 2
minutes. |
| Device cures with no appreciable
exothermic reaction | Device cures with no appreciable
exothermic reaction |

Performance Data

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, pyrogenicity and neurotoxicity.

6

Bench Testing

Test	Description	Conclusions
Visual Inspection	Evaluated putty component color
using a 3-point scale	Putty color and handling met
specification
Putty Handling	Evaluated putty stickiness to
gloves using a 3-point scale
Putty Stiffness	Measured putty stiffness using a
Penetrometer	Putty stiffness met
specification
Putty Vitamin E Acetate
Concentration	Solvent extraction and chemical
analysis	Putty vitamin E acetate
concentration met
specification
Hand Mixing Time	Evaluated hand-mixing time using
a 2-point scale	Mixing time, stickiness, and
mixability met specification
Hand Mixing Stickiness	Evaluated stickiness to gloves
using a 3-point scale
Mixability	Evaluated mixability using a 2-
point scale
Device Stiffness	Measured device stiffness using a
Penetrometer	Device stiffness met
specification
Package Gross Leak	Bubble emission leak test	All test articles passed
Temperature Sensitivity	Determined maximum
temperature increase observed
during mixing	Acceptable maximum
temperature increase
following hand-mixing
Water Uptake, Swelling
and Dissolution	Measured volume and mass
changes during 72 hours in
phosphate buffered saline, pH
7.4, at 37°C	Acceptable water uptake,
swelling and dissolution

In-Vivo Testing

In-vivo animal testing was used to demonstrate substantial equivalence of MONTAGE Settable, Resorbable Bone Putty in the repair of a critical sized cranial bone defect of New Zealand White rabbits compared to the predicate device. Substantial equivalence was assessed from histopathologic evaluation and histomorphometric measurements of implant absorption over time.

Clinical Testing

No clinical studies have been conducted in support of this 510(k).

Conclusions

This submission supports the position that Orthocon MONTAGE Settable. Resorbable Bone Putty is substantially equivalent to the predicate device.

The information provided establishes that similar legally marketed devices have been used for the same clinical applications as Orthocon MONTAGE Settable, Resorbable Bone Putty and that Substantial Equivalence to the predicate device has been established. Each of the tests conducted passed the requirements as stated in the protocols and in recognized standards. The data presented demonstrate that the device is suitable for its indicated use. The materials from which the Orthocon device is fabricated have an established history of use, and the devices have been tested in accordance with applicable FDA guidelines.