OSSIOfiber® Staple

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January 21, 2022 OSSIO Ltd. % David McGurl Director, Regulatory Affairs MCRA, LLC 803 7th Street NW Washington, District of Columbia 20001 Re: K212594 Trade/Device Name: OSSIOfiber® Staple Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: MNU Dated: January 10, 2022 Received: January 10, 2022 Dear David McGurl: 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 {1}------------------------------------------------ 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 https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 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). Sincerely, Limin Sun, Ph.D. Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K212594 Device Name OSSIOfiber® Staple Indications for Use (Describe) The OSSIOfiber® Staple is indicated for fixation of arthrodesis, osteotomies in hand or foot surgery in the presence of appropriate brace and/or immobilization. The number and size of the OSSIOfiber® Staples must be adapted to the indication. Type of Use (Select one or both, as applicable) | <div> <span> <svg class="bi bi-check-square" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M14 1H2a1 1 0 0 0-1 1v12a1 1 0 0 0 1 1h12a1 1 0 0 0 1-1V2a1 1 0 0 0-1-1zM2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2z" fill-rule="evenodd"></path> <path d="M10.97 4.97a.75.75 0 0 1 1.071 1.05l-3.992 4.99a.75.75 0 0 1-1.08.02L4.324 8.384a.75.75 0 1 1 1.06-1.06l2.094 2.093 3.473-4.425a.236.236 0 0 1 .02-.022z" fill-rule="evenodd"></path> </svg> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div> <span> <svg class="bi bi-square" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M14 1H2a1 1 0 0 0-1 1v12a1 1 0 0 0 1 1h12a1 1 0 0 0 1-1V2a1 1 0 0 0-1-1zM2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2z" fill-rule="evenodd"></path> </svg> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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 #### OSSIOfiber® Staple #### Submitter #### Ossio Ltd. 8 HaTochen Street, Caesarea, Israel, 3079861 Phone: +972-4-9986600 Facsimile: +972-4-9986601 Contact Person: Taly Lindner Date Prepared: Jan 16, 2022 Name of Device: OSSIOfiber® Staple Common or Usual Name: Staple, Absorbable Classification Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II, 21 C.F.R. § 888.3030 #### Product Code: MNU #### Predicate Devices OS2®-C Compression Staple (K153395) - Primary Predicate #### Reference Devices OSSIO® Pin Product Family (K181180) OSSIOfiber® Hammertoe Fixation System (K190652, K201803) OSSIOfiber® Compression Screw (K193660) #### Device Description The OSSIOfiber® Staple is a fixation implant made of degradable poly (L-lactide) (PLDLA) reinforced with continuous mineral fibers. OSSIOfiber® implants have been shown to be biocompatible. The polymer content degrades by hydrolysis into alpha-hydroxy acids that are metabolized by the body. The fibers are made of minerals that are found in natural bone. As the OSSIOfiber® implants degrade, the load transfers to the surrounding anatomy throughout the healing period of the osteotomy, fusion, or fracture. Substantial degradation takes place within approximately 18 months as shown in pre-clinical studies, thus eliminating the requirement for future hardware removal surgery. The OSSIOfiber® Staples are supplied sterile, for single patient use only, and non-pyrogenic. They are available in several sizes: 11-25 mm bridge lengths, and 15-22 mm leg lengths. The OSSIOfiber® Staples are designed to be used with commonly available orthopedic surgical tools such as ISO 9714 compatible instrumentations. {4}------------------------------------------------ ### Indications for Use The OSSIOfiber® Staple is indicated for fixation of arthrodesis, osteotomies, and fractures in hand or foot surgery in the presence of appropriate brace and/or immobilization. The number and size of the OSSIOfiber® Staples must be adapted to the indication. ## Summary of Technological Characteristics The OSSIOfiber® Staples have intended use, and similar indications for use, principles of operation and design characteristics as the primary predicate device the OS2®-C Compression Staple (K153395). The OSSIOfiber® Staples' material composition as well as the manufacturing and sterilization methods are the same as that of the cleared reference devices the OSSIO® Pin Product Family (K181180), OSSIOfiber® Hammertoe Fixation System (K190652, K201803) and OSSIOfiber® Compression Screw (K193660). Both subject device and the primary predicate device are supplied sterile. The OSSIOfiber® Staple is sterilized by EtO whereas the primary predicate is sterilized by Gamma. The subject device is made of OSSIOfiber® material while the primary predicate is made of PEEK. The OSSIOfiber® Staple has slightly longer leg and bridge lengths compared to the primary predicate. Although there are differences with regards to material, shape and size compared to the primary predicate, mechanical testing demonstrated at least equivalent performance both initially and after in vitro degradation. Any differences between OSSIOfiber® Staple and its primary predicate device do not raise different questions of safety and effectiveness. # Non-Clinical Data Static bending, bending fatigue and pull-out testing were performed as per ASTM F564-17 to verify the bending strength and stiffness, bending fatique strength, and pull-out fixation properties of the OSSIOfiber® Staple. Static bending and bending fatigue were compared to those of the primary predicate device (K153395). Pull-out testing was compared to those of the K181180 reference device. All testing were done initially and following in-vitro degradation. The in-vitro degradation profile was characterized. Biocompatibility for the implants was established primarily based on the referenced ISO 10993 data from the previously cleared reference devices (K181180, K190652, K193660, K201803) as well as a rationale. A rationale was provided to support the MR safe labeling of the implant. # Conclusions The OSSIOfiber® Staple is as safe and effective as its primary predicate device, the OS2®-C Compression Staple (K153395). The OSSIOfiber® Staples have the same intended use, and similar indications for use, principles of operation, and design characteristics as the primary predicate device the OS2®-C Compression Staple (K153395). Material composition is the same as the reference devices (K181180, K193660, K190652, K201803). The minor differences do not alter the intended surgical use of the implant and do not affect its safety and effectiveness when used as labeled. Non-clinical testing data demonstrate that the OSSIOffber® Staple is at least as safe and effective as the primary predicate device. Thus, the OSSIOfiber® Staple is substantially equivalent.