(164 days)
No
The device description and performance studies focus on the material properties and biological performance of a bone putty, with no mention of AI or ML technologies.
No.
The device is used for the repair of cranial defects, which is a structural repair rather than a direct therapeutic effect on a disease or condition.
No
Explanation: This device is a bone putty used for the repair of cranial defects, not for diagnostic purposes. Its function is to physically fill and repair, not to detect or identify medical conditions.
No
The device description clearly outlines a physical material (putty) composed of chemical components, intended for surgical implantation. There is no mention of software as a component or the primary function of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the repair of cranial defects, which is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a self-setting bone putty used to fill physical defects in bone.
- Lack of Diagnostic Activity: There is no mention of the device being used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease.
IVD devices are used to perform tests on samples like blood, urine, or tissue outside of the body to gain diagnostic information. This device is a therapeutic material used within the body for structural repair.
N/A
Intended Use / Indications for Use
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.
Product codes
GXP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranial defects, neurosurgical burr holes, contiguous craniotomy cuts
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
Bench Testing:
- Visual Inspection: Evaluated paste color using a reference scale. Conclusions: Paste color met specification.
- Paste Stiffness: Evaluated paste stiffness using a reference scale. Conclusions: Paste stiffness met specification.
- Package Leak Test: Bubble emission leak test. Conclusions: All test articles passed.
- Temperature Sensitivity: Not Found. Conclusions: Acceptable maximum temperature increase observed.
- Water Uptake, Swelling, and Dissolution: Measured volume and mass changes over time. Conclusions: 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).
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
September 26, 2024
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right of that is the FDA logo, which includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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).
1
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).
2
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
3
Indications for Use
Submission Number (if known)
Device Name
Permatage Settable Bone Putty
Indications for Use (Describe)
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.
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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4
510(k) SUMMARY- K241027 (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 | 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
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.
5
Indications for Use
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.
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 intended
for use in the repair of neurosurgical burr
holes, contiguous craniotomy cuts and
other cranial defects. | Stryker® Injectable Cement 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 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 | Stryker Injectable cement is formulated as
a two-part powder/liquid 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. | 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. |
6
| Radiopaque - Contains hydroxyapatite and β-
tricalcium phosphate | Radiopaque - Contains hydroxyapatite and β-
tricalcium phosphate |
|-------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Implanted device is nonabsorbable. | Implanted device is resorbable in greater
than 2 years 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
sizes 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 packages
containing putty-like components that are
mixed together immediately prior to use. | 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 seconds | 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 5
minutes. |
| Device cures with no appreciable
exothermic reaction. | Device cures with no appreciable
exothermic 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.
7
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 |
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.