← Product Code [MTJ](/productcode/MTJ) · K153095 # ROP Resorbable Hemostasis Material (K153095) _Resorbable Orthopedic Products, LLC · MTJ · Feb 17, 2016 · SU · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K153095 ## Device Facts - **Applicant:** Resorbable Orthopedic Products, LLC - **Product Code:** [MTJ](/productcode/MTJ.md) - **Decision Date:** Feb 17, 2016 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** SU - **Attributes:** Therapeutic ## Indications for Use ROP Bone Hemostasis Material is a water-soluble material indicated for use to control bleeding from bone surfaces. ## Device Story ROP Bone Hemostasis Material is a water-soluble, resorbable alkylene oxide copolymer blend used to control bleeding from bone surfaces during surgery. The device is provided in a stick-like form within a capped delivery tube, allowing surgeons to extrude and apply the material to bone defects similarly to a crayon. It functions via physical tamponade, sealing damaged bone and plugging vessels. The device is intended for use in healthcare facilities by surgeons. It is completely resorbed in vivo between 2 and 7 days. The delivery tube acts as a barrier between the surgeon's gloved hand and the material, facilitating application. The device benefits patients by providing effective hemostasis on bone surfaces while being fully resorbable, avoiding the long-term presence of foreign material. ## Clinical Evidence No human clinical data. Evidence consists of non-clinical bench testing and an in vivo animal study (ISO 10993-6) in rabbits. The animal study compared the subject device to the predicate, evaluating hemostasis, bone adherence, resorption, and bone defect healing. Results indicated the subject device performed similarly to the predicate, with complete resorption observed between 2 and 7 days and no negative impact on bone healing. Extensive biocompatibility testing (cytotoxicity, irritation, sensitization, genotoxicity, systemic toxicity, pyrogenicity) was performed per ISO 10993 standards. ## Technological Characteristics Material: Blend of water-soluble alkylene oxide copolymers. Form: Stick-like, 6.0g in delivery tube. Principle: Physical tamponade. Sterilization: Gamma irradiation. Shelf life: 3 years. Standards: ASTM D6007 (formaldehyde), ASTM D6330 (formaldehyde/EO), ASTM D6828 (stiffness), ASTM E1269 (molecular weight), USP-37 <741> (melting point), USP-37 <791> (pH), USP-37 <911> (molecular weight), USP-37 <197M> (ID), ISO 10993 (biocompatibility). ## Predicate Devices - Ostene® CT Soluble Bone Hemostasis Implant Material ([K082491](/device/K082491.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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. 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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 February 17, 2016 Resorbable Orthopedic Products, LLC % Ms. Patsy Trisler Regulatory Consultant Trisler Consulting 5600 Wisconsin Ave Chevy Chase, Maryland 20815 Re: K153095 Trade/Device Name: ROP Resorbable Hemostasis Material Regulatory Class: Unclassified Product Code: MTJ Dated: October 23, 2015 Received: October 26, 2015 Dear Ms. Trisler: 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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, # David Krause -S for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### Indications for Use 510(k) Number (if known) #### K153095 Device Name ROP Bone Hemostasis Material Indications for Use (Describe) ROP Bone Hemostasis Material is a water-soluble material indicated for use to control bleeding from bone surfaces. 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 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." . Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. {3}------------------------------------------------ # K153095 510(k) Summary | Submitter Name: | Resorbable Orthopedic Products, LLC | |-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter Address: | 16633 Dallas Parkway, Suite 250
Addison, TX 75001 | | Contact Person: | Barry E. Constantine
Bconst191@aol.com | | Phone Number: | 732-831-1797 | | Date Prepared: | October 23, 2015 | | Device Trade Name: | ROP Bone Hemostasis Material | | Common Name: | Wax, Bone | | Classification
Number: | Unclassified | | Product Code: | MTJ | | Device Class: | Unclassified | | Predicate Device(s): | K082491, Ostene® CT Soluble Bone Hemostasis Implant Material,
AOC™ Ostene™, Osteotene™, Ceretene™, Ceremed, Inc. | | Indications for Use
Statement: | ROP Bone Hemostasis Material is a water-soluble
material
indicated for use to control bleeding from bone surfaces. | | Device Description: | Device Identification and Materials of Use:
The ROP Bone Hemostasis Material is a blend of water-soluble
alkylene oxide copolymers. It contains no additives or colorants.

The product is provided in a stick-like form, contained in a capped
delivery tube. Each tube contains approximately 6.0 grams of the
material. It is to be extruded from the container by rotation of the
base of the tube for application to bleeding bone defect. The ROP
Bone Hemostasis Material is, as the predicate, a water soluble
wax-like substance and is slippery when wet. The delivery tube is a
barrier between the surgeon's wet gloved hand and the material,
permitting application to the boney defect in the manner similar to
handling a crayon.

ROP Bone Hemostasis Material is sterilized by a validated gamma
irradiation process. It is labeled for single surgical use and is not to
be resterilized. The tube is provided in a secondary wrap to permit
delivery into a sterile field.

Body Contact:
The device is a resorbable material in contact with bone tissue for | less than 30 days. {4}------------------------------------------------ ## Mechanism of Action: The ROP Bone Hemostasis Material acts as a physical hemostasis agent, by means of a tamponade action. It stops bleeding by sealing the damaged bone and plugging the vessels. Testing has shown the device is completely resorbed between the 2- and 7-day evaluation time points. ## Environment of Use: The device is for use only in a health care facility/hospital during surgical procedures. - Summary of Non-clinical testing has been performed in accordance with FDA Testing: quidance and standards as follows. # Material and Device Characterization Testing #### Laboratory Testing Raw Material Testing: - Formaldehyde Content (VOL): ASTM #D6007 - Formaldehyde and Ethylene Oxide Content: EPA Method-. 316, ASTM #D6330 - Ethylene Glycol, Diethylene Glycol Impurities: USP-37 - Leachable Organic Compounds: USP-37 <1663/1634. . ASTM #D7823 - . Stiffness: ASTM#D6828 Device Characterization testing was performed as follows: - . Melting point: USP-37<741> - Viscosity: The product is a solid at room temperature. - . Adherence to bone surface (as part of the implantation study and the ignition potential study) - Appearance/Texture: Visual/Tactile USP-37 - Weight Consistency: Gravimetric - . pH: USP-37 <791> - Molecular Weight (Saybolt Viscocity): USP 37 <911> - Molecular Weight (Thermo Gravimetry): ASTM #E1269 - ID: FT-IR USP-37 <197M) - . Ignition Potential was evaluated by an independent test laboratory, with no evidence of ignition observed. Swelling - a characteristic critical to assess in many bone tissue contact products, is not pertinent because the ROP Bone Hemostasis Material dissolves in water, and therefore does not swell. {5}------------------------------------------------ #### Animal Testing In vivo performance testing was conducted as part of the ISO 10993-6 study to evaluate the following in addition to local tissue response: - . Hemostasis - . Device Adherence to bone - Resorption ● - . Bone defect healing Results showed the ROP material performed similarly to the predicate Ostene. Both are hemostatic, adhere to bone, resorb and do not show a negative impact on bone healing. #### Biocompatibility Testing: The following testing was performed according to ISO 10993 and data are provided in the 510(k) which demonstrate the device is biocompatible and non-toxic. - . Cytotoxicity: Certified to ISO 13485 and Accredited to ISO 17025 and 10993 Part 5 - . ISO Modified Intracutaneous Irritation in the Rabbit: ISO 10993-10 - . Guinea Pig Maximization Sensitization Test: ISO 10993-1, -2, -10, -12 and ISO 13485. - . Genotoxicity: 1.) Mouse Peripheral Blood Micronucleus Study: OECD Test No. 474. 2.) Bacterial Reverse Mutation Study with Dose Range Finding Study: ISO 10993, OECD 471. - . Dose Range Finding Study with a Definitive Mouse Lymphoma Assay: ASTM #E-1280, Standard Guide for Performing the Mouse Lymphoma Assay for Mammalian Cell Mutagenicity and the OECD Test #476. - . ISO Bone Implantation Study in the mid shaft femur of rabbits, 48 hours, 1 and 4 weeks: ISO 10993-6 - Systemic Toxicity in Mice: USP/NF <88>, ISO 10993-11 - . ISO Systemic Toxicity in the Rat following Subcutaneous implantation, 4 weeks: ISO 10993-11 and ISO 10993-6 - USP Rabbit Pvrogen Study: USP/NF <151>. ISO 10993-11 . #### Sterilization and Shelf life: The final packaged product is sterilized via gamma irradiation. The validated shelf life of the ROP Bone Hemostasis Material will be 3 years. {6}------------------------------------------------ Comparison to the ROP Bone Hemostasis Material has the same intended use Predicate Devices: and the same principles of operation as the predicate device - to stop bleeding bone tissue by a physical means and to resorb in situ. > It is composed of a material that is substantially equivalent to the predicate: both are water-soluble, resorbable, alkylene oxide copolymers. > The predicate bone hemostasis material is provided in a peel-back foil packet, which is different from the tube in which the ROP Bone Hemostasis Material is provided. > The ROP Bone Hemostasis Material is sterilized via Gamma Irradiation, while the Ostene product is sterilized via Electron Beam Irradiation. > These differences in packaging and sterilization methods do not raise new safety and effectiveness questions. Substantial Based on the above comparisons, as well as the study data Equivalence presented in the 510(k) in which the proposed device was Conclusion: evaluated in comparison to the predicate device in the expanded ISO 10993-6 study, it is concluded that the ROP Bone Hemostasis Material is substantially equivalent to the predicate Ostene Hemostasis Material. --- **Source:** [https://fda.innolitics.com/device/K153095](https://fda.innolitics.com/device/K153095) **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. 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