Kisar Stratford SI Screw System

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Anjali Investments L.L.C % Jennifer Palinchik President Jalex Medical LLC 27865 Clemens Road Suite 3 Westlake, Ohio 44145 Re: K220274 Trade/Device Name: Kisar Stratford SI Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: OUR Dated: March 15, 2023 Received: March 16, 2023 Dear Jennifer Palinchik: 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. 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Assistant Director DHT6B: Division of Spinal 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) K220274 Device Name Kisar Stratford SI Screw System Indications for Use (Describe) The Kisar Stratford SI Screw system is intended for fusion of the sacroillac joint for conditions including SI joint dysfunction resulting from SI joint disruption or degenerative sacroillitis. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| | <div style="display:inline-block;">☑</div> Executive/Senior OTE Member Plan | □ In-The-Application OTE Member Plan | |-----------------------------------------------------------------------------|--------------------------------------| |-----------------------------------------------------------------------------|--------------------------------------| X 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." {3}------------------------------------------------ # 510(k) Summary | Submitted By: | Anjali Investments, LLC | |------------------------------|---------------------------------------------------------------------------------------------------------------------------------| | Date: | 03/15/2023 | | Contact Person: | Jennifer Palinchik | | Contact Telephone: | (440) 541-0060 | | Contact Fax: | (440) 933-7839 | | Device Trade Name: | Kisar Stratford SI Screw System | | Common Name: | Smooth or threaded metallic bone fixation fastener | | Device Classification Name: | Sacroiliac joint fixation (21 CFR 888.3040) | | Device Classification: | Class II | | Reviewing Panel: | Orthopedic | | Product Code: | OUR | | Primary Predicate Device: | K021932 - Synthes 6.5 cannulated bone screw, partially threaded. The primary predicate device has not been subject to a recall. | | Additional Predicate Device: | K191748 - Genesys Spine Sacroiliac Joint Fusion System<br>K152237 - CoreLink Entasis® SI Joint Fusion System | ## Device Description: The Kisar Stratford SI Screw System consists of threaded, fenestrated implant screws with a porous layer and an instrument system. The screws are inserted into the sacroiliac (SI) joint and intended to prevent and minimize motion of the joint thus promoting joint fusion. Bone graft material may be used in the fenestration of the implants as an additional means of promoting joint fusion. The screws are available in multiple diameters and lengths to accommodate different patient anatomy. All implants are fabricated from medical grade titanium alloy per ASTM F3001 and system instrumentation is manufactured from surgical grade stainless steel and other surgical grade materials. #### Indications for Use: The Kisar Stratford SI Screw system is intended for fusion of the sacroiliac joint for conditions including SI joint dysfunction resulting from SI joint disruption or degenerative sacroiliitis. #### Summary of Technological Characteristics: The Kisar Stratford SI Screw system and the predicate have the same intended use and fundamental scientific technology. A comparison table of the subject device and predicate devices technological characteristics is provided in this submission in Section XIV Substantial Equivalence. A condensed comparison table is also presented below. There are no differences in technological characteristics that raise questions of safety and efficacy. {4}------------------------------------------------ | Item | Kisar Stratford SI Screw<br>System | Synthes 6.5<br>Cannulated Bone<br>Screw (K021932) | Genesys Spine Sacroiliac<br>Joint Fusion System<br>(K191748) | CoreLink Entasis<br>(K152237) | Comparison | |---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Device | Sacroiliac Joint Fixation | Screw, Fixation, Bone<br>Sacroiliac Joint<br>Fixation | Sacroiliac Joint Fixation | Sacroiliac Joint<br>Fixation | Equivalent | | Regulation<br>Description | Smooth or threaded<br>metallic bone fixation<br>fastener | Smooth or threaded<br>metallic bone fixation<br>fastener | Smooth or threaded metallic<br>bone fixation fastener | Smooth or threaded<br>metallic bone fixation<br>fastener | Equivalent | | Regulation | 21 CFR 888.3040 | 21 CFR 888.3040 | 21 CFR 888.3040 | 21 CFR 888.3040 | Equivalent | | Product Code | OUR | HWC, OUR | OUR | OUR | Equivalent | | Indications for<br>Use | The Kisar Stratford SI<br>Screw system is intended<br>for fusion of the sacroiliac<br>joint for conditions<br>including SI joint<br>dysfunction resulting from<br>SI joint disruption or<br>degenerative sacroiliitis. | The DePuy Synthes 6.5<br>mm Cannulated Screws<br>are intended for fixation<br>of fractures, fusions,<br>osteotomies, non-<br>unions,<br>and malunions of long<br>bones and long bone<br>fragments, pelvis,<br>sacrum, and the bones<br>of the foot in adults and<br>in both<br>children (2-12 years)<br>and adolescents (12-21<br>years) in which growth<br>plates have fused or in<br>which growth plates<br>will not<br>be crossed by screw<br>fixation. These screws<br>are also indicated for | The Genesys Spine<br>Sacroiliac Joint Fusion<br>System is intended for<br>sacroiliac joint fusion for<br>conditions including<br>sacroiliac joint disruptions<br>and degenerative sacroiliitis | The Entasis™ Dual-<br>Lead Sacroiliac<br>Implant system is<br>intended for sacroiliac<br>joint fusion for<br>conditions including<br>degenerative<br>sacroiliitis and<br>sacroiliac joint<br>disruptions. | Equivalent | | | | femoral neck fractures;<br>slipped capital femoral<br>epiphysis; an adjunct to<br>DHS in basilar neck<br>fractures; tibial plateau<br>fractures; ankle<br>arthrodesis; pediatric<br>femoral neck<br>fractures; intercondylar<br>femur fractures; SI joint<br>disruptions; and<br>subtalar arthrodesis. | | | | | Description | The Kisar Stratford SI<br>Screw system consists of<br>fully threaded implant<br>screws with a porous layer<br>and an instrument system.<br>The screws are inserted<br>into the sacroiliac (SI) joint<br>and intended to prevent<br>and minimize motion of<br>the joint thus promoting<br>joint fusion. Bone graftmaterial may be used in the<br>fenestration of the implants<br>as an additional means of<br>promoting joint fusion. The<br>screws are available in<br>multiple diameters and<br>lengths to accommodate<br>different patient anatomy.<br>All implants are fabricated<br>from medical grade<br>titanium alloy and system<br>instrumentation is | The DePuy Synthes<br>Ø6.5 mm Cannulated<br>Screws are intended for<br>fixation of fractures,<br>fusions,<br>osteotomies, non-<br>unions, and malunions<br>of long bones and long<br>bone fragments, pelvis,<br>sacrum, and the bones<br>of the foot in adults and<br>in both children (2-12<br>years) and adolescents<br>(12-21 years) in which<br>growth plates have<br>fused or in which<br>growth plates will not<br>be crossed.<br>by screw fixation.<br>These screws are also<br>indicated for femoral<br>neck fractures; slipped<br>capital | Genesys Spine's Sacroiliac<br>Joint Fusion System<br>consists of partially<br>threaded and fully threaded<br>implants designed to secure<br>the sacroiliac joint and<br>minimize micromotion in<br>order to enable bony fusion.<br>All screws and anchors are<br>cannulated and self-tapping;<br>they are offered with<br>different diameters (up to<br>13.5mm), lengths (up to<br>70mm), and styles to<br>accommodate variations in<br>patient anatomy and<br>surgeon preference. Fusion<br>across the graft space can be<br>aided by the addition of<br>bone graft material to the<br>lumen of each screw;<br>fenestration in each screw | The Entasis™ Dual-<br>Lead Sacroiliac<br>Implant system is<br>composed of dual-lead<br>sacroiliac screws<br>manufactured from<br>titanium (Ti-6Al-4V<br>ELI) per ASTM F136.<br>The screws are<br>available in<br>lengths of 30-70mm<br>and diameters of 7-<br>11.5mm. | Equivalent | | | manufactured from<br>surgical grade stainless<br>steel and other surgical<br>grade materials. | femoral epiphysis; an<br>adjunct to DHS in<br>basilar neck fractures;<br>tibial plateau fractures;<br>ankle<br>arthrodesis; pediatric<br>femoral neck fractures;<br>intercondylar femur<br>fractures; SI joint<br>disruptions;<br>and subtalar<br>arthrodesis. | apposition across the<br>sacroiliac joint. Dual thread<br>screws and fully threaded<br>screws provide joint<br>compression by utilizing a<br>compressive thread pattern.<br>Optional Washers are<br>included to aid in<br>conforming to patient<br>anatomy and to help<br>distribute the load onto a<br>larger area. All implants are<br>fabricated from medical<br>grade titanium alloy (Ti-<br>6Al-4V ELI). The delivery<br>system uses guide pins for<br>accurate surgical placement<br>into pre-drilled bone. All<br>implants will be provided<br>non-sterile and are intended<br>for single use only. | | | | Screw<br>Diameters | Ø9.5 nominal thread<br>diameter<br>Ø11.5 nominal thread<br>diameter | Ø6.5 nominal thread<br>diameter | Ø9.5 nominal thread<br>diameter<br>Ø11.5 nominal thread<br>diameter<br>Ø13.5 nominal thread<br>diameter | Ø7.0 nominal thread<br>diameter<br>Ø9.5 nominal thread<br>diameter<br>Ø11.5 nominal thread<br>diameter | Equivalent | | Screw<br>Lengths | Ø9.5 & Ø11.5 - 30mm-<br>110mm in 5mm increments | 30mm-150mm in 5mm<br>increments<br>160-180mm in 10mm<br>increments<br>Partially threaded,<br>16mm thread length | Ø13.5 & 11.5 - 30-70 in<br>5mm increments<br>Ø9.5 – 35-70mm in 5 mm<br>increments | All sizes - 30-70mm<br>long | Equivalent | Table 1: Dimensions and Technological Characteristics Comparison {5}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------ #### Mechanical Testing: Substantial equivalence is supported by the results of mechanical testing which includes torsion, driving torque, and axial pullout testing per ASTM F543, and static and dynamic cantilever bend testing per ASTM F2193. Static tensile strength per ASTM F1147, Static Shear Strength per ASTM F1044, Shear Fatigue testing per ASTM F1160, and Particulate Characterization per ASTM F1877 were performed to assess the performance of the devices' porous structures. Results support that the subject device performs as well as or better than the chosen acceptance criteria. Mechanical testing methods, data, and reports are provided in this submission. ## Conclusion: Based on the indications for use, technological characteristics, and comparison with the predicate device, the subject device has demonstrated substantial equivalence.