Orthocon Permatage Settable Bone Putty is a self-setting cement indicated for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects. Permatage Settable Bone Putty should be used only in skeletally mature individuals.

Device Description

Permatage Settable Bone Putty is a sterile, biocompatible, nonabsorbable material of putty-like consistency for use in repair of cranial defects. The single use Permatage device contains two separate components of putty-like consistency comprised of granular calcium phosphate, paraffin oil, vitamin E acetate, a triglyceride, and a mixture of nonabsorbable, polyether-based polymers. When mixed together, the components of the Permatage device form a nonabsorbable cohesive, putty-like material that adheres to the bone surface and remains in place following application. The resulting hardening material is primarily calcium phosphate and nonabsorbable polymer materials. Permatage components must be mixed immediately prior to use.

AI/ML Overview

The provided text is a 510(k) summary for the Orthocon Permatage Settable Bone Putty, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria through a traditional clinical study with performance metrics like sensitivity or specificity.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert involvement, and ground truth establishment for an AI/algorithm-based device is not applicable to this document. The document describes a traditional medical device (bone putty) and its regulatory clearance process, which relies on biocompatibility testing, bench testing, and in-vivo animal testing to demonstrate substantial equivalence to an existing device, not an AI or software algorithm.

Here's a breakdown of why each section of your request cannot be fulfilled from the provided text:

Table of acceptance criteria and reported device performance: Not present. The "Performance Data" section lists various tests (e.g., Visual Inspection, Paste Stiffness, Package Leak Test) and states that they "met specification" or "passed," but it does not provide specific numerical acceptance criteria or quantitative performance results.
Sample sized used for the test set and the data provenance: Not present for a "test set" in the context of an algorithm. The in-vivo animal testing mentions demonstrating substantial equivalence in "an animal model," but does not specify the sample size of animals or their provenance.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI algorithm is not relevant here. The in-vivo animal testing involved "histopathologic evaluation," which would have been performed by experts, but their number and qualifications are not specified.
Adjudication method: Not applicable.
MRMC comparative effectiveness study: Not applicable, as this is not an AI-assisted device.
Standalone performance (algorithm only without human-in-the-loop): Not applicable, as this is not an AI/algorithm device.
Type of ground truth used: For the in-vivo animal testing, "histopathologic evaluation" served as a form of ground truth for assessing the bone defect repair.
Sample size for the training set: Not applicable, as there is no training set for an AI algorithm.
How the ground truth for the training set was established: Not applicable.

Summary based on available information:

The document describes the regulatory clearance of a bone putty device (Permatage Settable Bone Putty) based on its substantial equivalence to another marketed device (Stryker HydroSet Injectable Cement). The evaluation involved:

Biocompatibility Testing: Conducted in accordance with ISO 10993, including tests for cytotoxicity, irritation, sensitization, systemic toxicity, genotoxicity, local tissue toxicity, hemolysis, pyrogenicity, and neurotoxicity. All tests were conducted on the final, finished, gamma-irradiation sterilized device and in accordance with GLP requirements.
Bench Testing:
- Visual Inspection: Evaluated paste color using a reference scale. Conclusion: Paste color met specification.
- Paste Stiffness: Evaluated paste stiffness using a reference scale. Conclusion: Paste stiffness met specification.
- Package Leak Test: Bubble emission leak test. Conclusion: All test articles passed.
- Temperature Sensitivity: Acceptable maximum temperature increase observed. Conclusion: Acceptable maximum temperature increase observed.
- Water Uptake, Swelling, and Dissolution: Measured volume and mass changes over time. Conclusion: Acceptable water uptake, swelling, and dissolution.
In-Vivo Testing:
- Study Design: Used to demonstrate substantial equivalence in the repair of a critical-sized cranial bone defect in an animal model compared to the comparator device.
- Ground Truth: Substantial equivalence was assessed based on histopathologic evaluation.
- Sample Size/Provenance: Not specified beyond "an animal model."
Clinical Testing: No clinical studies were conducted in support of this 510(k).

The document concludes that the device is substantially equivalent to the predicate device, and the conducted tests passed stated requirements and recognized standards.

Summary

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September 26, 2024

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

Re: K241027

Trade/Device Name: Permatage Settable Bone Putty Regulation Number: 21 CFR 882.5300 Regulation Name: Methyl Methacrylate For Cranioplasty Regulatory Class: Class II Product Code: GXP Dated: August 27, 2024 Received: August 27, 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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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).

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Sincerely,

Digitally signed by Adam D. Adam D. Pierce -S Pierce -S Date: 2024.09.26 13:53:13 -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 Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K241027

Device Name

Permatage Settable Bone Putty

Indications for Use (Describe)

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)

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510(k) SUMMARY- K241027 (Per 21 CFR 807.92)

General Company Information

Name:	Orthocon, Inc.
Contact:	Howard SchrayerRegulatory Affairs Consultant
Address:	700 Fairfield Avenue, Suite 1Stamford, CT 06902
Telephone:	(855) 475 - 9175
Date	September 26, 2024
General Device Information

Product Name:	Permatage Settable Bone Putty
Common Name:	Methyl Methacrylate for Cranioplasty
Classification:	Class II
Product codes:	GXP
Regulation:	21 CFR 882.5300

Predicate Devices: Primary Predicate:

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

Reference Devices:

Orthocon, Inc. HBP7 Settable Hemostatic Bone Putty [510(k) Number K202363]

Device Description

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Indications for Use

The following table shows comparisons of characteristics of Permatage Settable Bone Putty and the predicate device.

SUBSTANTIAL EQUIVALENCE INFORMATION

Orthocon, Inc. Permatage Settable Bone Putty 510(k) — K241027

Stryker Injectable Cement HydroSet

510(k) - K060763

Comparisons of Technological Characteristics

Permatage Settable Bone Putty is intendedfor use in the repair of neurosurgical burrholes, contiguous craniotomy cuts andother cranial defects.	Stryker® Injectable Cement is intended foruse in the repair of neurosurgical burrholes, contiguous craniotomy cuts andother cranial defects.
Product Code GXP	Product Code GXP
At the time of application, device is in theform of a spreadable material	At the time of application, device is in theform of a spreadable material
Device is designed to be manually appliedto the cranial defect	Device is designed to be applied to thecranial defect with a manually operateddispenser
Permatage Settable Bone Putty isformulated as a two-part putty/putty devicethat forms a "settable" (hardening) materialwhen mixed at the time of surgery	Stryker Injectable cement is formulated asa two-part powder/liquid device that formsa "settable" (hardening) material whenmixed at the time of surgery
Permatage Settable Bone Putty is a sterile,biocompatible, nonabsorbable material ofputty-like consistency for use in repair ofcranial defects. The single use Permatagedevice contains two separate components ofputty-like consistency comprised of granularcalcium phosphate, paraffin oil, vitamin Eacetate, a triglyceride, and a mixture ofnonabsorbable, polyether-based polymers.When mixed together, the components of thePermatage device form a nonabsorbablecohesive putty-like material that adheres to thebone surface and remains in place followingapplication. The resulting hardening material isprimarily comprised of calcium phosphate andnonabsorbable polymer materials.	Sterile mixture of two separatecomponents, a powder comprised ofdicalcium phosphate dihydrate,tetracalcium phosphate and tri-sodiumcitrate; and a liquid comprised of sodiumphosphate, polyvinylpyrrolidone andwater. Stryker Injectable Cement is to bemanually mixed immediately prior to use.Resulting settable material from the twocomponents is primarily comprised ofcalcium phosphate.

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Radiopaque - Contains hydroxyapatite and β-tricalcium phosphate	Radiopaque - Contains hydroxyapatite and β-tricalcium phosphate
Implanted device is nonabsorbable.	Implanted device is resorbable in greaterthan 2 years primarily due to presence ofcalcium phosphate.
Single-patient-use device is provided sterileby gamma irradiation	Single-patient-use device is providedsterile by gamma irradiation and ethyleneoxide
The bone putty is available in individualsizes of 5cc.	The device is available in individual;and/or multi-pack patient use sizes of 3, 5,10 and 15cc.
The putty is provided in two foil packagescontaining putty-like components that aremixed together immediately prior to use.	Each kit contains one liquid-filled glasssyringe and one plastic bowl of powderpackaged within a double pre-formed traywith a Tyvek lid.
Mixing for homogeneity takes 45 seconds	Mixing for homogeneity takes 45 sec.
Material is settable within 10 minutes ofapplication	Material is settable within 10 minutes ofapplication
Material provides a working time of 2minutes.	Material provides a working time of 5minutes.
Device cures with no appreciableexothermic reaction.	Device cures with no appreciableexothermic reaction

Testing Completed

Biocompatibility Testing

Testing was conducted to evaluate 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.

Performance Data

Performance testing included a series of laboratory evaluations and in vivo testing. These evaluations are summarized below.

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Bench Testing

Test	Description	Conclusions
Visual Inspection	Evaluated paste colorusing a reference scale	Paste colormet specification
Paste Stiffness	Evaluated paste stiffnessusing a reference scale	Paste stiffness metspecification
Package Leak Test	Bubble emission leak test	All test articles passed
Temperature Sensitivity	Acceptable maximum temperatureincrease observed	Acceptable maximumtemperature increase observed
Water Uptake,Swellingand Dissolution	Measured volume and masschanges over time	Acceptable water uptake,swelling and dissolution

In-Vivo Testing

In-vivo animal testing was used to demonstrate substantial equivalence of Permatage Settable Bone Putty in the repair of a critical sized cranial bone defect in an animal model compared to the comparator device. Substantial equivalence was assessed based on histopathologic evaluation.

Clinical Testing

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

Conclusions

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

The information provided establishes that similar legally marketed devices, including the primary predicate, have been used for the same clinical application as Orthocon Permatage Settable 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 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 quidelines. Any differences between Permatage and the predicate do not raise new concerns or risks.

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).