(448 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and design of the screw system, with no mention of AI or ML capabilities.
Yes
The device is intended for fusion of the sacroiliac joint to treat SI joint dysfunction or degenerative sacroiliitis, with the goal of promoting joint fusion and preventing/minimizing motion. This directly addresses the pathology and aims to restore normal function.
No
The device description clearly states its purpose is to prevent and minimize motion of the joint, promoting fusion. There is no mention of diagnostic capabilities; its function is purely therapeutic/interventional.
No
The device description explicitly states it consists of threaded, fenestrated implant screws and an instrument system, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The Kisar Stratford SI Screw system is a surgical implant designed to be inserted into the sacroiliac joint to promote fusion. It is a physical device used within the body, not for testing samples outside the body.
- Intended Use: The intended use is for fusion of the sacroiliac joint, a surgical procedure, not a diagnostic test.
Therefore, the Kisar Stratford SI Screw system falls under the category of a surgical implant or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
OUR
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Sacroiliac joint (SI joint)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
April 24, 2023
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
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
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,
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)
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) |
|---|
| ------------------------------------------------- |
| ☑ 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)
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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 |
| 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
System | Synthes 6.5
Cannulated Bone
Screw (K021932) | Genesys Spine Sacroiliac
Joint Fusion System
(K191748) | CoreLink Entasis
(K152237) | Comparison |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Device | Sacroiliac Joint Fixation | Screw, Fixation, Bone
Sacroiliac Joint
Fixation | Sacroiliac Joint Fixation | Sacroiliac Joint
Fixation | Equivalent |
| Regulation
Description | Smooth or threaded
metallic bone fixation
fastener | Smooth or threaded
metallic bone fixation
fastener | Smooth or threaded metallic
bone fixation fastener | Smooth or threaded
metallic bone fixation
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
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. | The DePuy Synthes 6.5
mm Cannulated Screws
are intended for fixation
of fractures, fusions,
osteotomies, non-
unions,
and malunions of long
bones and long bone
fragments, pelvis,
sacrum, and the bones
of the foot in adults and
in both
children (2-12 years)
and adolescents (12-21
years) in which growth
plates have fused or in
which growth plates
will not
be crossed by screw
fixation. These screws
are also indicated for | The Genesys Spine
Sacroiliac Joint Fusion
System is intended for
sacroiliac joint fusion for
conditions including
sacroiliac joint disruptions
and degenerative sacroiliitis | The Entasis™ Dual-
Lead Sacroiliac
Implant system is
intended for sacroiliac
joint fusion for
conditions including
degenerative
sacroiliitis and
sacroiliac joint
disruptions. | Equivalent |
| | | femoral neck fractures;
slipped capital femoral
epiphysis; an adjunct to
DHS in basilar neck
fractures; tibial plateau
fractures; ankle
arthrodesis; pediatric
femoral neck
fractures; intercondylar
femur fractures; SI joint
disruptions; and
subtalar arthrodesis. | | | |
| Description | The Kisar Stratford SI
Screw system consists of
fully threaded 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 graftmaterial 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 and system
instrumentation is | The DePuy Synthes
Ø6.5 mm Cannulated
Screws are intended for
fixation of fractures,
fusions,
osteotomies, non-
unions, and malunions
of long bones and long
bone fragments, pelvis,
sacrum, and the bones
of the foot in adults and
in both children (2-12
years) and adolescents
(12-21 years) in which
growth plates have
fused or in which
growth plates will not
be crossed.
by screw fixation.
These screws are also
indicated for femoral
neck fractures; slipped
capital | Genesys Spine's Sacroiliac
Joint Fusion System
consists of partially
threaded and fully threaded
implants designed to secure
the sacroiliac joint and
minimize micromotion in
order to enable bony fusion.
All screws and anchors are
cannulated and self-tapping;
they are offered with
different diameters (up to
13.5mm), lengths (up to
70mm), and styles to
accommodate variations in
patient anatomy and
surgeon preference. Fusion
across the graft space can be
aided by the addition of
bone graft material to the
lumen of each screw;
fenestration in each screw | The Entasis™ Dual-
Lead Sacroiliac
Implant system is
composed of dual-lead
sacroiliac screws
manufactured from
titanium (Ti-6Al-4V
ELI) per ASTM F136.
The screws are
available in
lengths of 30-70mm
and diameters of 7-
11.5mm. | Equivalent |
| | manufactured from
surgical grade stainless
steel and other surgical
grade materials. | femoral epiphysis; an
adjunct to DHS in
basilar neck fractures;
tibial plateau fractures;
ankle
arthrodesis; pediatric
femoral neck fractures;
intercondylar femur
fractures; SI joint
disruptions;
and subtalar
arthrodesis. | apposition across the
sacroiliac joint. Dual thread
screws and fully threaded
screws provide joint
compression by utilizing a
compressive thread pattern.
Optional Washers are
included to aid in
conforming to patient
anatomy and to help
distribute the load onto a
larger area. All implants are
fabricated from medical
grade titanium alloy (Ti-
6Al-4V ELI). The delivery
system uses guide pins for
accurate surgical placement
into pre-drilled bone. All
implants will be provided
non-sterile and are intended
for single use only. | | |
| Screw
Diameters | Ø9.5 nominal thread
diameter
Ø11.5 nominal thread
diameter | Ø6.5 nominal thread
diameter | Ø9.5 nominal thread
diameter
Ø11.5 nominal thread
diameter
Ø13.5 nominal thread
diameter | Ø7.0 nominal thread
diameter
Ø9.5 nominal thread
diameter
Ø11.5 nominal thread
diameter | Equivalent |
| Screw
Lengths | Ø9.5 & Ø11.5 - 30mm-
110mm in 5mm increments | 30mm-150mm in 5mm
increments
160-180mm in 10mm
increments
Partially threaded,
16mm thread length | Ø13.5 & 11.5 - 30-70 in
5mm increments
Ø9.5 – 35-70mm in 5 mm
increments | All sizes - 30-70mm
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.