Permatage Flowable, Settable Bone Paste

K253732 · Orthocon, Inc. · GXP · Mar 13, 2026 · Neurology

Device Facts

• Record ID: K253732
• Device Name: Permatage Flowable, Settable Bone Paste
• Applicant: Orthocon, Inc.
• Product Code: GXP · Neurology
• Decision Date: Mar 13, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Permatage Flowable, Settable Bone Paste is a sterile, nonabsorbable, two-part bone cement used for cranial defect repair; indicated for neurosurgical burr holes and craniotomy cuts. Device consists of granular calcium phosphate, paraffin oil, vitamin E acetate, triglyceride, and nonabsorbable polyether-based polymers. Components are supplied in a dual-barrel cartridge and mixed immediately prior to application via a manually operated dispenser. Material adheres to bone surface and hardens in situ within 10 minutes without appreciable exothermic reaction. Used in clinical/neurosurgical settings by physicians. Benefits include stable, cohesive repair of cranial defects in skeletally mature patients.

Clinical Evidence

No clinical data. Bench testing only: visual inspection, paste stiffness, package leak test, temperature sensitivity, and water uptake/swelling/dissolution testing performed. All tests met specifications.

Technological Characteristics

Two-part paste-paste system; components: granular calcium phosphate, paraffin oil, vitamin E acetate, triglyceride, nonabsorbable polyether-based polymers. Radiopaque (hydroxyapatite/β-tricalcium phosphate). Supplied in dual-barrel cartridge (up to 16cc). Sterile (gamma irradiation). Manual dispenser application. Nonabsorbable. Cures in 10 minutes; no exothermic reaction.

Indications for Use

Indicated for repair of neurosurgical burr holes, contiguous craniotomy cuts, and other cranial defects in skeletally mature individuals.

Regulatory Classification

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.

Predicate Devices

• Permatage Settable Bone Putty (K241027)

Reference Devices

• HBP7 Settable Hemostatic Bone Putty (K202363)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

March 13, 2026

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

Re: K253732
Trade/Device Name: Permatage Flowable, Settable Bone Paste
Regulation Number: 21 CFR 882.5300
Regulation Name: Methyl Methacrylate For Cranioplasty
Regulatory Class: Class II
Product Code: GXP
Dated: February 9, 2026
Received: February 10, 2026

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).

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K253732 - Howard Schrayer
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Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13484 clause 8.3 (Nonconforming product), and ISO 13485 clause 8.5 (Corrective and preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 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 (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-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (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-devices/device-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

JULIA E. SLOCOMB -S
Digitally signed by JULIA E. SLOCOMB -S
Date: 2026.03.13 15:19:48 -04'00'

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K253732 - Howard Schrayer
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for Jaime Raben, Ph.D.
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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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services [phone]
EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K253732 | |
| Device Name Orthocon Permatage Flowable, Settable Bone Paste | |
| Indications for Use (Describe) Orthocon Permatage Flowable, Settable Bone Paste is a self-setting cement indicated for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects. Permatage Flowable, Settable Bone Paste 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) | |
| 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 [e-mail] | |
| "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." | |

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510(k) SUMMARY- K253723
(Per 21 CFR 807.92)

## General Company Information

Name: Orthocon, Inc.
Contact: Howard Schrayer
Regulatory Affairs Consultant
Address: 700 Fairfield Avenue, Suite 1
Stamford, CT 06902
Telephone: (855) 475 - 9175
Date Prepared: March 13, 2026

## General Device Information

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

## Predicate Devices:

### Primary Predicate:

Orthocon, Inc. Permatage Settable Bone Putty
[510(k) Number K241027]

### Reference Device:

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

## Device Description

Permatage Flowable, Settable Bone Paste is a sterile, biocompatible, nonabsorbable material of Paste-like consistency for use in repair of cranial defects. The single use Permatage device contains two separate components of paste-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, paste-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.

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# Indications for Use

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

The following table shows comparisons of characteristics of Permatage Flowable, Settable Bone Paste and the predicate device.

## SUBSTANTIAL EQUIVALENCE INFORMATION

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

Orthocon, Inc.
Permatage Flowable, Settable
Bone Paste
510(k) - 253732

## Comparisons of Technological Characteristics

| Permatage Settable Bone Putty is intended for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects. | Permatage Flowable, Settable Bone Paste is intended for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects. |
| --- | --- |
| | |
| Product Code GXP | Product Code GXP |
| | |
| At the time of application, device is in the form of a spreadable material | At the time of application, device is in the form of a flowable, spreadable material |
| | |
| Device is designed to be manually applied to the cranial defect | Device is designed to be applied to the cranial defect with a manually operated dispenser |
| | |
| Permatage Settable Bone Putty is formulated as a two-part putty/putty device that forms a “settable” (hardening) material when mixed at the time of surgery | Permatage Flowable, Settable Bone Paste is formulated as a two-part paste/paste device that forms a “settable” (hardening) material when mixed at the time of surgery |
| | |
| 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 comprised of calcium phosphate and nonabsorbable polymer materials. | Permatage Flowable, Settable Bone Paste is a sterile, biocompatible, nonabsorbable material of paste-like consistency for use in repair of cranial defects. The single use Permatage device contains two separate components of paste-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 paste-like material that adheres to the bone surface and remains in place following application. The resulting hardening material is primarily comprised of calcium phosphate and nonabsorbable polymer materials. |

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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 nonabsorbable. |
| Single-patient-use device is provided sterile by gamma irradiation | Single-patient-use device is provided sterile by gamma irradiation |
| The bone putty is available in individual sizes of up to 10cc. | The bone paste is available in individual sizes of up to 16cc. |
| The putty is provided in two foil packages within a single outer foil pouch. The outer foil pouch contains a desiccant. The pouch is heat sealed and sterilized. | The paste is provided in a dual-barrel cartridge within a single outer foil pouch. The outer foil pouch contains a desiccant. The pouch is heat sealed and sterilized. |
| Mixing for homogeneity takes 45 seconds | Mixing for homogeneity is immediate |
| 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 |

# Biocompatibility Risk Assessment

All differences between the K253732 subject device, Permatage Flowable Settable Bone Paste, the K241027 predicate device, Permatage Settable Bone Putty, and the K202363 reference device, HBP7 Settable Hemostatic Bone Putty, were assessed with regard to the following biocompatibility endpoints: cytotoxicity, sensitization, irritation, acute systemic toxicity, material mediated pyrogenicity, subacute/subchronic toxicity, genotoxicity, implantation, neurotoxicity, hemocompatibility (indirect hemolysis), chronic toxicity, and carcinogenicity. Information in the biocompatibility risk assessment provided adequate rationale to address these biocompatibility endpoints.

# Performance Data

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

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# Bench Testing

| Test | Description | Conclusions |
| --- | --- | --- |
| Visual Inspection | Evaluated paste color using a reference scale | Paste color met specification |
| Paste Stiffness | Evaluated paste stiffness using a reference scale | Paste stiffness met specification |
| Package Leak Test | Bubble emission leak test | All test articles passed |
| Temperature Sensitivity | Acceptable maximum temperature increase observed | Acceptable maximum temperature increase observed |
| Water Uptake, Swelling and Dissolution | Measured volume and mass changes over time | Acceptable water uptake, swelling and dissolution |

# Clinical Testing

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

# Conclusions

This submission supports the position that Orthocon Permatage Flowable, Settable Bone Paste 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 Flowable, Settable Bone Paste 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 guidelines. The data presented demonstrate that the device is suitable for its indicated use. Any differences between Permatage and the predicate do not raise new concerns or risks.