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 sacroiliitis.

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.

AI/ML Overview

The provided text is a 510(k) summary for the Kisar Stratford SI Screw System. It describes the device, its intended use, and compares its technological characteristics to predicate devices. However, this document does not contain information about acceptance criteria or a study proving that the device meets those criteria, as typically found in clinical studies for AI/ML-enabled devices.

The "Mechanical Testing" section briefly mentions acceptance criteria in the context of mechanical performance. Since the request is likely for AI/ML device evaluations, and this document pertains to a medical screw system, the requested information (sample size for test/training sets, experts for ground truth, adjudication methods, MRMC studies, standalone performance) is not applicable or present in this document.

The document focuses on demonstrating substantial equivalence based on:

Intended Use: Fusion of the sacroiliac joint for conditions including SI joint dysfunction resulting from SI joint disruption or degenerative sacroiliitis.
Technological Characteristics: Materials (medical grade titanium alloy), design (threaded, fenestrated implant screws with porous layer), and dimensions (diameters, lengths).
Mechanical Testing: Torsion, driving torque, axial pullout, static and dynamic cantilever bend, static tensile strength, static shear strength, shear fatigue, and particulate characterization.

Based on the provided text, none of the requested information regarding acceptance criteria and studies (as would be relevant for an AI/ML device) can be extracted.

The "Mechanical Testing" section merely states: "Results support that the subject device performs as well as or better than the chosen acceptance criteria." It does not define those acceptance criteria or detail the study design in a way that aligns with the questions posed for AI/ML device evaluations.

Summary

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April 24, 2023

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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. 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

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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,

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Colin O'Neill, M.B.E. 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

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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)
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☑ Executive/Senior OTE Member Plan	□ In-The-Application OTE Member Plan
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X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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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 SystemK152237 - CoreLink Entasis® SI Joint Fusion System

Device Description:

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.

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Item	Kisar Stratford SI ScrewSystem	Synthes 6.5Cannulated BoneScrew (K021932)	Genesys Spine SacroiliacJoint Fusion System(K191748)	CoreLink Entasis(K152237)	Comparison
Device	Sacroiliac Joint Fixation	Screw, Fixation, BoneSacroiliac JointFixation	Sacroiliac Joint Fixation	Sacroiliac JointFixation	Equivalent
RegulationDescription	Smooth or threadedmetallic bone fixationfastener	Smooth or threadedmetallic bone fixationfastener	Smooth or threaded metallicbone fixation fastener	Smooth or threadedmetallic bone fixationfastener	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 forUse	The Kisar Stratford SIScrew system is intendedfor fusion of the sacroiliacjoint for conditionsincluding SI jointdysfunction resulting fromSI joint disruption ordegenerative sacroiliitis.	The DePuy Synthes 6.5mm Cannulated Screwsare intended for fixationof fractures, fusions,osteotomies, non-unions,and malunions of longbones and long bonefragments, pelvis,sacrum, and the bonesof the foot in adults andin bothchildren (2-12 years)and adolescents (12-21years) in which growthplates have fused or inwhich growth plateswill notbe crossed by screwfixation. These screwsare also indicated for	The Genesys SpineSacroiliac Joint FusionSystem is intended forsacroiliac joint fusion forconditions includingsacroiliac joint disruptionsand degenerative sacroiliitis	The Entasis™ Dual-Lead SacroiliacImplant system isintended for sacroiliacjoint fusion forconditions includingdegenerativesacroiliitis andsacroiliac jointdisruptions.	Equivalent
		femoral neck fractures;slipped capital femoralepiphysis; an adjunct toDHS in basilar neckfractures; tibial plateaufractures; anklearthrodesis; pediatricfemoral neckfractures; intercondylarfemur fractures; SI jointdisruptions; andsubtalar arthrodesis.
Description	The Kisar Stratford SIScrew system consists offully threaded implantscrews with a porous layerand an instrument system.The screws are insertedinto the sacroiliac (SI) jointand intended to preventand minimize motion ofthe joint thus promotingjoint fusion. Bone graftmaterial may be used in thefenestration of the implantsas an additional means ofpromoting joint fusion. Thescrews are available inmultiple diameters andlengths to accommodatedifferent patient anatomy.All implants are fabricatedfrom medical gradetitanium alloy and systeminstrumentation is	The DePuy SynthesØ6.5 mm CannulatedScrews are intended forfixation of fractures,fusions,osteotomies, non-unions, and malunionsof long bones and longbone fragments, pelvis,sacrum, and the bonesof the foot in adults andin both children (2-12years) and adolescents(12-21 years) in whichgrowth plates havefused or in whichgrowth plates will notbe crossed.by screw fixation.These screws are alsoindicated for femoralneck fractures; slippedcapital	Genesys Spine's SacroiliacJoint Fusion Systemconsists of partiallythreaded and fully threadedimplants designed to securethe sacroiliac joint andminimize micromotion inorder to enable bony fusion.All screws and anchors arecannulated and self-tapping;they are offered withdifferent diameters (up to13.5mm), lengths (up to70mm), and styles toaccommodate variations inpatient anatomy andsurgeon preference. Fusionacross the graft space can beaided by the addition ofbone graft material to thelumen of each screw;fenestration in each screw	The Entasis™ Dual-Lead SacroiliacImplant system iscomposed of dual-leadsacroiliac screwsmanufactured fromtitanium (Ti-6Al-4VELI) per ASTM F136.The screws areavailable inlengths of 30-70mmand diameters of 7-11.5mm.	Equivalent
	manufactured fromsurgical grade stainlesssteel and other surgicalgrade materials.	femoral epiphysis; anadjunct to DHS inbasilar neck fractures;tibial plateau fractures;anklearthrodesis; pediatricfemoral neck fractures;intercondylar femurfractures; SI jointdisruptions;and subtalararthrodesis.	apposition across thesacroiliac joint. Dual threadscrews and fully threadedscrews provide jointcompression by utilizing acompressive thread pattern.Optional Washers areincluded to aid inconforming to patientanatomy and to helpdistribute the load onto alarger area. All implants arefabricated from medicalgrade titanium alloy (Ti-6Al-4V ELI). The deliverysystem uses guide pins foraccurate surgical placementinto pre-drilled bone. Allimplants will be providednon-sterile and are intendedfor single use only.
ScrewDiameters	Ø9.5 nominal threaddiameterØ11.5 nominal threaddiameter	Ø6.5 nominal threaddiameter	Ø9.5 nominal threaddiameterØ11.5 nominal threaddiameterØ13.5 nominal threaddiameter	Ø7.0 nominal threaddiameterØ9.5 nominal threaddiameterØ11.5 nominal threaddiameter	Equivalent
ScrewLengths	Ø9.5 & Ø11.5 - 30mm-110mm in 5mm increments	30mm-150mm in 5mmincrements160-180mm in 10mmincrementsPartially threaded,16mm thread length	Ø13.5 & 11.5 - 30-70 in5mm incrementsØ9.5 – 35-70mm in 5 mmincrements	All sizes - 30-70mmlong	Equivalent

Table 1: Dimensions and Technological Characteristics Comparison

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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.

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.