(170 days)
Not Found
No
The device description and performance studies focus solely on the mechanical properties and surgical implantation of titanium screws for sacroiliac joint fusion. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis, which is a medical treatment.
No
Explanation: The device is a fusion system, specifically implants (screws), intended for sacroiliac joint fusion to provide stability. It is a therapeutic device, not a diagnostic device which identifies or characterizes a disease or condition.
No
The device description explicitly details physical implants made of titanium, which are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for sacroiliac joint fusion, which is a surgical procedure to stabilize a joint within the body. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as surgical implants (screws) made of titanium, designed to be inserted into the body. This is consistent with a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
Therefore, the Integrity-SI™ Fusion System is a surgical implant device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Integrity-SI Fusion System device is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
Product codes (comma separated list FDA assigned to the subject device)
OUR
Device Description
The Integrity-SI™ Fusion System consists of partially and fully threaded, self-tapping cannulated titanium (Ti-6Al-4V ELI per ASTM F136) implants designed to be inserted across sacroiliac joint to provide stability for joint arthrodesis. The surgical implants are available in various sizes to accommodate patient anatomy. The 10mm and 12mm diameter screws are offered in and partially and fully threaded versions in lengths ranging from 40-110mm, in 5mm increments. All screw sizes are available in non-coated or hydroxyapatite-coated (HA) versions. The 10mm and 12mm screws also include a pre-assembled washer for improved joint compression. The fully threaded 6.5mm diameter, optional secondary screws are offered from lengths of 30 - 70 mm, in 5mm increments. All implants are provided sterile and are individually packaged. The 6.5 mm screws are not for use without the subject 10 mm or 12 mm screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sacroiliac joint
Indicated Patient Age Range
skeletally mature individuals
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)
Testing was performed for the Integrity-SI™ Fusion System and demonstrated substantially equivalent performance to the identified predicates. The following mechanical tests were performed: Torsional strength/breaking angle (ASTM F543-13e1) Insertion/removal torque (ASTM F543-13e1) Pullout force (ASTM F543-13e1) Static Bending Strength (ASTM F2193-14) Fatigue Bending Strength (ASTM F2193-14) Tests completed for insertion torque and axial pullout strength demonstrate the subject devices are substantially equivalent with respect to mechanical performance of the K021932 predicate device. Additionally, testing for torque to failure, mean bending yield strength and bending fatigue life provide evidence the device is capable of withstanding expected loading without failure. Cadaveric testing demonstrates the subject device can be safely implanted using the surgical technique.
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 14, 2016
CoorsTek Medical LLC Mr. Steve Brown QA/RA Manager 560 West Golf Course Road Providence, Utah 84332
Re: K161755
Trade/Device Name: Integrity-SI"M Fusion System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: OUR Dated: November 17, 2016 Received: November 18, 2016
Dear Mr. Steve Brown:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K161755
Device Name Integrity-SI Fusion System
Indications for Use (Describe)
The Integrity-SI Fusion System device is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for CoorsTek Medical. The word "CoorsTek" is written in a stylized font, with the "Coors" part in red and the "TEK" part in black. Below "CoorsTek" is the word "MEDICAL" in smaller, black letters. The logo is simple and professional, and it is likely used to represent the company in its marketing and branding materials.
Section 4: 510(k) SUMMARY [As required by 21 CFR 807.92 (c)]
Submitter / Contact Person / Date of Preparation
| Submitter/Sponsor | CoorsTek Medical LLC
560 W. Golf Course Rd.
Providence, UT 84332
Phone: 435-774-1535
Fax: 435-753-7698 |
|---------------------|--------------------------------------------------------------------------------------------------------------------|
| Contact Person | Steve Brown |
| Date of preparation | December 9th, 2016 |
General Information
| Trade Name | Integrity-SI™ Fusion System |
|---|---|
| Common / Usual Name | Sacroiliac Joint Fixation - Smooth or threaded metallic bone fixation fastener |
| Classification Name and Number | Sacroiliac Joint Fixation, 888. 3040 |
| Regulatory Class | Class II |
| Device Regulation Panel | Orthopedics |
| Product Code | OUR |
| Manufacturer | CoorsTek Medical LLC |
| 560 W. Golf Course Rd. | |
| Providence, UT 84332 | |
| Identification of Legally | |
| Marketed Predicate | |
| Devices | Synthes 6.5 mm Cannulated Screw (K021932) Zyga Technology SImmetry® Sacroiliac Joint Fusion System (K141549) Medtronic Sofamor Danek MSB Sacroiliac Joint Fusion Device (K110472) |
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Image /page/4/Picture/0 description: The image shows the logo for CoorsTek Medical. The word "Coors" is in red, and the word "Tek" is in black. The word "Medical" is in smaller black font below the word "Tek".
| Device Description | The Integrity-SITM Fusion System consists of partially and fully
threaded, self-tapping cannulated titanium (Ti-6Al-4V ELI per
ASTM F136) implants designed to be inserted across sacroiliac
joint to provide stability for joint arthrodesis. The surgical implants
are available in various sizes to accommodate patient anatomy.
The 10mm and 12mm diameter screws are offered in and partially
and fully threaded versions in lengths ranging from 40-110mm, in
5mm increments. All screw sizes are available in non-coated or
hydroxyapatite-coated (HA) versions. The 10mm and 12mm
screws also include a pre-assembled washer for improved joint
compression. The fully threaded 6.5mm diameter, optional
secondary screws are offered from lengths of 30 - 70 mm, in 5mm
increments. All implants are provided sterile and are individually
packaged. The 6.5 mm screws are not for use without the subject
10 mm or 12 mm screws. |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The system is used to provide structural stability in skeletally
mature individuals who have developed a clinical need to alleviate
chronic pain due to SI joint disruptions and degenerative
sacroiliitis. |
| Indications for Use | Integrity-SITM Fusion System is intended for sacroiliac joint fusion
for conditions including sacroiliac joint disruptions and
degenerative sacroilitis. |
| Indications for Use
Comparison | The intended use for the subject and predicate devices are the
same. The indications for use statement for the subject device
and the Zyga Technology Simmetry (K021932) and Medtronic
Sofamor Danek MSB Sacroiliac Joint Fusion Device (K110472)
predicates are identical. The Synthes 6.5 mm Cannulated Screw
(K021932) indications for use statement is broader than the
subject device but does include SI joint disruptions. |
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Image /page/5/Picture/0 description: The image shows the logo for CoorsTek Medical. The word "CoorsTek" is written in a stylized font, with the "Coors" in red and the "Tek" in black. Below the word "CoorsTek" is the word "Medical" in a smaller, sans-serif font. The logo is simple and professional, and it is likely used on the company's website and marketing materials.
| Summary of Non-Clinical
Performance Data | Testing was performed for the Integrity-SI™ Fusion System and
demonstrated substantially equivalent performance to the
identified predicates. The following mechanical tests were
performed: Torsional strength/breaking angle (ASTM F543-13e1) Insertion/removal torque (ASTM F543-13e1) Pullout force (ASTM F543-13e1) Static Bending Strength (ASTM F2193-14) Fatigue Bending Strength (ASTM F2193-14) Tests completed for insertion torque and axial pullout strength demonstrate the subject devices are substantially equivalent with respect to mechanical performance of the K021932 predicate device. Additionally, testing for torque to failure, mean bending yield strength and bending fatigue life provide evidence the device is capable of withstanding expected loading without failure. Cadaveric testing demonstrates the subject device can be safely implanted using the surgical technique. |
|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
Characteristics
Comparison | The technological characteristics and intended use of the subject devices is identical to that of the predicate devices cleared under the following submissions: K141559 Slmmetry Sacroiliac Joint Fusion System K110472 Medtronic Sacroiliac Fusion Device K021932 Synthes 6.5mm Cannulated Screw Both subject and predicate devices include titanium alloy bone screws that are inserted across the SI joint to provide a stable construct to promote arthrodesis across the joint. As a result, the subject device does not introduce any new concerns of safety or effectiveness. |
| Conclusion | Based upon a comparison of the design features, indications for use, technological characteristics, the use of established well known materials, and mechanical performance, the Integrity-SI™ Fusion System has demonstrated substantial equivalence to the identified predicate device systems. The performance data demonstrates that the devices included in the Integrity-SI™ Fusion System do not raise any new questions of safety or effectiveness. |