← Product Code MTJ · K202363 # HBP7 Settable Hemostatic Bone Putty (K202363) _Orthocon, Inc. · MTJ · Jan 19, 2021 · SU · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K202363 ## Device Facts - **Applicant:** Orthocon, Inc. - **Product Code:** MTJ - **Decision Date:** Jan 19, 2021 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** SU - **Attributes:** Therapeutic ## Intended Use HBP7 Settable Hemostatic Bone Putty is indicated for the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade. ## Device Story HBP7 is a sterile, nonabsorbable, putty-like material for bone hemostasis. It consists of two components—granular calcium phosphate, paraffin oil, vitamin E acetate, a triglyceride, and nonabsorbable polyether-based polymers—that must be manually mixed immediately prior to use. Once mixed, the putty is applied directly to surgically cut or traumatically broken bone. It functions as a mechanical barrier (tamponade) to occlude vascular openings in the bone, hardening within minutes of application. The device is intended for use by clinicians in surgical settings. It provides a permanent implant that mimics the mineral phase of native bone tissue, benefiting patients by effectively controlling intraoperative bone bleeding. ## Clinical Evidence No clinical data. Evidence consists of bench testing (relative stiffness, spreadability, stickiness, temperature sensitivity, electrocautery compatibility, dissolution, swelling), biocompatibility testing (cytotoxicity, irritation, sensitization, acute systemic toxicity, genotoxicity, implantation, local tissue toxicity, hemolysis, endotoxicity, pyrogenicity), and animal studies demonstrating intraoperative in vivo hemostasis and resistance to irrigation. ## Technological Characteristics Two-part putty system; components: granular calcium phosphate, paraffin oil, vitamin E acetate, triglyceride, nonabsorbable polyether-based polymers. Resulting material >60% calcium phosphate by weight. Form factor: settable putty. Sterilization: gamma irradiation. Permanent implant. Nonabsorbable. ## Predicate Devices - CP Medical Bone Wax ([K024372](/device/K024372.md)) - HBP4 Hardening, Resorbable Hemostatic Bone Putty ([K141502](/device/K141502.md)) - MONTAGE Settable Hemostatic Bone Putty ([K152005](/device/K152005.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. January 19, 2021 Orthocon, Inc. Howard Schrayer Official Correspondent 1 Bridge Street, Suite 121 Irvington, New York 10533 Re: K202363 Trade/Device Name: HBP7 Settable Hemostatic Bone Putty Regulatory Class: Unclassified Product Code: MTJ Dated: December 17, 2020 Received: December 18, 2020 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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see {1}------------------------------------------------ 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, Cindy Chowdhury, Ph.D., M.B.A. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use 510(k) Number (if known) K202363 Device Name HBP7 Settable Hemostatic Bone Putty Indications for Use (Describe) HBP7 Settable Hemostatic Bone Putty is indicated for the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade. 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) Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. #### 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 PRAStaff(@fda.hhs.gov "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." {3}------------------------------------------------ # 510(k) Summary | Contact: | Howard Schrayer
Orthocon, Inc.
1 Bridge Street, Suite 121
Irvington, NY 10533
Telephone: 914-357-2600
Fax: 914-231-7884
hs.ss@lucidmedical.net | |--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Date Prepared: | August 17, 2020 | | Device Trade Name: | HBP7 Settable Hemostatic Bone Putty | | Manufacturer: | Orthocon, Inc.
1 Bridge Street, Suite 121
Irvington, NY 10533 | | Common Name: | Bone wax | | Classification: | Unclassified | | Product Code: | MTJ | | Predicate Devices | Primary Predicate
CP Medical Bone Wax A formulation based on
beeswax, paraffin and isopropyl palmitate
[510(k) K024372]

Reference Predicate
Orthocon, Inc.
HBP4 Hardening, Resorbable Hemostatic Bone Putty
510(k) K141502

Orthocon, Inc. MONTAGE Settable Hemostatic Bone
Putty
510(k) K152005 | {4}------------------------------------------------ ## Indications for Use: HBP7 Settable Hemostatic Bone Putty is indicated for the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade. ## Device Description: HBP7 Settable Hemostatic Bone Putty is a sterile, biocompatible, nonabsorbable material of putty-like consistency for use in the control of bleeding from bone surfaces. The single use HBP7 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, polyetherbased polymers. When mixed together, the components of the HBP7 device form a nonabsorbable putty-like material that can be applied directly to bleeding bone. The resulting material is primarily comprised of calcium phosphate. HBP7 must be mixed immediately prior to use. When applied to surgically cut or traumatically broken bone. HBP7 Settable Hemostatic Bone Putty achieves local control of bleeding by acting as a mechanical barrier (tamponade). #### Substantial Equivalence and Predicate Devices: The device was shown to be substantially equivalent to previously cleared bone wax devices including CP Medical Bone Wax (K024372), HBP4 Hardening Resorbable Hemostatic Bone Putty (K141502) and Montage Settable Hemostatic Bone Putty (K152005). #### Performance Testing: Bench testing, biocompatibility and animal functionality testing performed on HBP7 Settable Hemostatic Bone Putty demonstrate that the device is substantially equivalent to the predicate devices 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 over a range of temperatures and to evaluate the device's dissolution properties. The following bench studies were completed: relative stiffness, spreadability, stickiness, temperature sensitivity, electrocautery compatibility, dissolution and swelling. Biocompatibility 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-irradiated sterile device in accordance with the GLP requirements: cytotoxicity, irritation, sensitization, acute systemic toxicity, genotoxicity, implantation, local tissue toxicity, hemolysis, endotoxicity and pyrogenicity. Animal Testing included animal studies to demonstrate intraoperative in vivo hemostasis and resistance to irrigation. The following table summarizes the substantial equivalence of HBP7 to the predicate devices. {5}------------------------------------------------ | Manufacturer | Orthocon, Inc. | CP Medical | Orthocon, Inc. | | |---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade Name | HBP7 Settable Hemostatic
Bone Putty | CP Medical Bone Wax | MONTAGE™ Settable,
Resorbable Hemostatic Bone
Putty | | | 510(k) Number | Subject Device - TBD | K024372 | K141502 and K152005 | | | Type of Device/
Product Code | Bone wax / MTJ | Bone wax / MTJ | Bone wax / MTJ | | | Indications for Use | HBP7 Settable Hemostatic
Bone Putty is indicated in the
control of bleeding from cut or
damaged bone by acting as a
mechanical barrier or
tamponade | The CP Medical Bone Wax is
indicated for use in the control
of bleeding from bone
surfaces. | MONTAGE Settable,
Resorbable Hemostatic Bone
Putty is indicated in the control
of bleeding from cut or
damaged bone by acting as a
mechanical barrier or
tamponade | | | | Intended Use | Bone hemostasis | Bone hemostasis | Bone hemostasis | | | Mechanism of
Action | Mechanical tamponade that
occludes vascular openings in
damaged bone | Mechanical tamponade that
occludes vascular openings in
damaged bone | Mechanical tamponade that
occludes vascular openings in
damaged bone | | Form of Device | | HBP7 Settable Hemostatic
Bone Putty is formulated as a
two-part putty/putty device that
forms a "settable" (hardening)
putty when manually mixed at
the time of surgery. | CP Medical Bone Wax is a
putty-like material formulated
from bee's wax, isopropyl
palmitate and paraffin that is
kneaded to soften and apply
and then forms a firm
tamponade after application. | MONTAGE Settable,
Resorbable Hemostatic Bone
Putty is formulated as a two-
part putty/putty device that
forms a "settable" (hardening)
putty when manually mixed at
the time of surgery. | | | | | Radiopaque - Contains | Not radiopaque | | | Radiopacity | hydroxyapatite and β-tricalcium phosphate | | hydroxyapatite and β-tricalcium phosphate | | | Materials | Sterile mixture of two components of putty-like consistency comprised of granular calcium phosphate, (hydroxyapatite and β-tricalcium phosphate), paraffin, vitamin E acetate, triacetin, and a mixture of nonabsorbable polymers. HBP7 is to be mixed immediately prior to use. Resulting settable material from the two putties is primarily comprised (> 60% by weight) of calcium phosphate similar to the mineral phase of native bone tissue. | Sterile mixture of bee's wax, isopropyl palmitate and paraffin that forms a putty-like consistency with no chemical interactions. | Sterile mixture of two 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 (> 60% by weight) of calcium phosphate similar to the mineral phase of native bone tissue. | | | Absorbable | No | No | Yes | | | In Vivo Residence
Time | Permanent Implant | Permanent Implant | Greater than 30 days
primarily due to presence of
calcium phosphate | | | Method of | Manually applied and spread | Manually applied and spread | Manually applied and spread | | Application | onto bone tissue | onto bone tissue | onto bone tissue | | | Degradation
Process | Nonabsorbable in the body -
permanent implant | Nonabsorbable in the body -
permanent implant | The non-calcium salt and
non-polymeric components
degrade via dissolution; the
polymer degrades via
hydrolysis and calcium salts
degrade via chemical
dissolution and/or cellular
removal | | | Sterility | Provided sterile for single use
by gamma irradiation | Provided sterile for single use
by gamma irradiation | Provided sterile for single use
by gamma irradiation | | | Set Time | Sets (hardens) within minutes of
application | N/A | Sets (hardens) within minutes
of application | | # Predicate Comparison Table {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ ## Conclusion HBP7 is substantially equivalent to previously cleared bone hemostasis devices with respect to intended use, general technological characteristics and performance. --- **Source:** [https://fda.innolitics.com/device/K202363](https://fda.innolitics.com/device/K202363) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com