Kisar Stratford SI Screw System

K220274 · Anjali Investments L.L.C · OUR · Apr 24, 2023 · Orthopedic

Device Facts

• Record ID: K220274
• Device Name: Kisar Stratford SI Screw System
• Applicant: Anjali Investments L.L.C
• Product Code: OUR · Orthopedic
• Decision Date: Apr 24, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

Kisar Stratford SI Screw System consists of threaded, fenestrated titanium alloy implant screws with porous layer and associated surgical instrumentation. Device used in clinical setting by surgeons to perform sacroiliac (SI) joint fusion. Screws inserted into SI joint to prevent/minimize motion, promoting fusion; bone graft material may be placed in screw fenestrations to further aid fusion. Available in multiple diameters/lengths to accommodate patient anatomy. System provides mechanical stabilization of joint; benefits patient by addressing SI joint dysfunction and degenerative sacroiliitis through surgical stabilization.

Clinical Evidence

Bench testing only. Mechanical performance validated via torsion, driving torque, and axial pullout (ASTM F543); static/dynamic cantilever bend (ASTM F2193); static tensile strength (ASTM F1147); static shear strength (ASTM F1044); shear fatigue (ASTM F1160); and particulate characterization (ASTM F1877).

Technological Characteristics

Implants fabricated from medical grade titanium alloy (ASTM F3001). Instrumentation manufactured from surgical grade stainless steel. Features threaded, fenestrated design with porous surface layer. Available in multiple diameters and lengths. Non-sterile, single-use.

Indications for Use

Indicated for fusion of the sacroiliac joint in patients with SI joint dysfunction resulting from SI joint disruption or degenerative sacroiliitis.

Regulatory Classification

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.

Predicate Devices

• Synthes 6.5 cannulated bone screw (K021932)
• Genesys Spine Sacroiliac Joint Fusion System (K191748)
• CoreLink Entasis® SI Joint Fusion System (K152237)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Image /page/1/Picture/5 description: The image contains the text "Colin O'neill -S" in a simple, sans-serif font. The text is arranged vertically, with "Colin" on the top line and "O'neill -S" on the bottom line. To the right of the text is a faded, light blue logo that appears to be the letters "FDA".

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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| <div style="display:inline-block;">☑</div> 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: | [phone] |
| Contact Fax: | [phone] |
| 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.

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| 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

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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.