(237 days)
No
The device description focuses on the mechanical properties and design of titanium implants for sacroiliac joint fusion. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies are mechanical tests, not related to algorithmic performance.
Yes
The device is intended for sacroiliac joint fusion to treat specific conditions like sacroiliac joint dysfunction, degenerative sacroiliitis, and fractures, which are medical conditions, and its function of providing stability and immobilization contributes to their treatment.
No
The device description indicates that the Integrity-SI® Fusion System consists of implants designed to provide stability for sacroiliac joint arthrodesis, which is a treatment for certain conditions, not a means of diagnosis.
No
The device description explicitly details physical implants (screws, washers) made of titanium, indicating it is a hardware medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The Integrity-SI® Fusion System is a system of surgical implants (screws) designed to be inserted into the body to stabilize the sacroiliac joint.
- Intended Use: The intended use is for sacroiliac joint fusion, which is a surgical procedure to stabilize a joint within the body.
The device is a surgical implant used in vivo (within the body), not a device used to test samples in vitro (outside the body).
N/A
Intended Use / Indications for Use
The Integrity-SI® Fusion System is intended for sacroiliac joint fusion for the following conditions:
-
Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroilitis. This includes conditions whose symptoms began during pregnancy or in the period and have persisted postpartum for more than 6 months.
-
To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
-
Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.
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 implants designed to be inserted across sacroiliac joint providing stability for joint arthrodesis when used in conjunction with allograft or autograft. The surgical implants are available in various sizes to accommodate patient anatomy. The 8 mm, 10 mm, and 12 mm diameter screws are offered in partially and fully threaded version in lengths from 40 - 1 10 mm, in 2.5 mm increments and are available in non-coated or hydroxyapatite-coated (HA) versions. The screws also include a pre-assembled washer for improved joint compression. The fully threaded 6.5 mm diameter, optional, secondary fasteners are offered for additional rotational stability in lengths of 30 - 70 mm, in 5 mm increments and are only intended for use in conjunction with a primary 8 mm, 10 mm, or 12 mm screw.
The screws are provided in sterile and non-sterile options.
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 patients
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 of the subject device was undertaken in accordance with ASTM F543-17 to demonstrate substantial equivalence. The following tests were performed:
- Torsional properties per ASTM F543-17 ●
- Driving and removal torque per ASTM F543-17
- Axial pullout per ASTM F543-17 ●
In addition, this submission leverages verification and validation testing previously submitted by the applicant under K161755 and K210754.
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.
Integrity-SI® Fusion System, K222512, CoorsTek Integrity-SI Fusion System, K161755, Cannulated Fasteners and Nuts, K211290, Synthes 6.5 mm Cannulated Screw, K021932, SI-Cure Sacroiliac Joint Fusion System, K231951
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
September 21, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the text "U.S. FOOD & DRUG ADMINISTRATION" is written in blue.
OsteoCentric Technologies % Roshana Ahmed Sr Regulatory Specialist Telos Partners LLC 2458 Frontier Drive Warsaw, Indiana 46582
Re: K230226
Trade/Device Name: Integrity-SI® 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: August 25, 2023 Received: August 25, 2023
Dear Roshana Ahmed:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (QS) 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 medical devices and radiation-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).
Sincerelv.
Eileen
Cadel -
S
Digitally signed
by Eileen Cadel
-S
Date:
2023.09.21
14:59:18 -04'00'
for
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
2
Indications for Use
510(k) Number (if known) K230226
Device Name
Integrity-SI® Fusion System
Indications for Use (Describe)
The Integrity-SI Fusion System is intended for sacroiliac joint fusion for the following conditions:
-
Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroilitis. This includes conditions whose symptoms began during pregnancy or in the period and have persisted postpartum for more than 6 months.
-
To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
-
Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
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
I. Submitter
OsteoCentric Technologies 75 West 300 N. Suite 150 Logan, UT 84321 Phone: 1-800-969-0639
Submitter Contact Person: Todd Evans, Senior Director of Quality and Regulatory Affairs Submission Contact Person: Roshana Ahmed, M.A., RAC, Sr. Regulatory Specialist
Date Prepared: September 19, 2023
II. Device
| Device Proprietary Name: | Integrity-SI® Fusion System |
|---|---|
| Common or Usual Name: | Sacroiliac Joint Fixation |
| Classification Name: | Smooth or threaded metallic bone fixation fastener |
| Regulation Number: | 21 CFR 888.3040 |
| Product Code: | OUR |
| Device Classification: | Class II |
III. Predicate Device
Primary predicate:
-
Integrity-SI® Fusion System, K222512, OsteoCentric Technologies
Additional predicates: -
CoorsTek Integrity-SI Fusion System, K161755, CoorsTek Medical, LLC
-
Cannulated Fasteners and Nuts, K211290, OsteoCentric Technologies
-
Synthes 6.5 mm Cannulated Screw, K021932, Synthes (USA) ●
-
SI-Cure Sacroiliac Joint Fusion System, K231951, Alevio, LLC ●
IV. Device Description
The Integrity-SI® Fusion System consists of partially and fully threaded, self-tapping cannulated titanium implants designed to be inserted across sacroiliac joint providing stability for joint arthrodesis when used in conjunction with allograft or autograft. The surgical implants are available in various sizes to accommodate patient anatomy. The 8 mm, 10 mm, and 12 mm diameter screws are offered in partially and fully threaded version in lengths from 40 - 1 10 mm, in 2.5 mm increments and are available in non-coated or hydroxyapatite-coated (HA) versions. The screws also include a pre-assembled washer for improved joint compression. The fully
4
threaded 6.5 mm diameter, optional, secondary fasteners are offered for additional rotational stability in lengths of 30 - 70 mm, in 5 mm increments and are only intended for use in conjunction with a primary 8 mm, 10 mm, or 12 mm screw.
The screws are provided in sterile and non-sterile options.
V. Indications for Use
The Integrity-SI Fusion System is intended for sacroiliac joint fusion for the following conditions:
- -Sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.
- To augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
- Acute, non-acute, and non-traumatic fractures involving the sacroiliac joint. -
Comparison of Technological Characteristics to the Predicate VI.
There are no changes to the Indications for Use statement.
The subject device is identical to the predicate device with respect to materials of construction, sterilization, and manufacturing methods. The only difference between the subject and predicate device is introduction of the 8 mm fastener, introduction of additional fastener sizes in 2.5 mm increments, addition of non-sterile fasteners to the product line, and the addition of new instruments (5.0 mm drill, taps, and new depth gauge).
VII. Performance Data
Mechanical testing of the subject device was undertaken in accordance with ASTM F543-17 to demonstrate substantial equivalence. The following tests were performed:
- Torsional properties per ASTM F543-17 ●
- Driving and removal torque per ASTM F543-17
- Axial pullout per ASTM F543-17 ●
In addition, this submission leverages verification and validation testing previously submitted by the applicant under K161755 and K210754.
VIII. Conclusion
As noted above, the only difference between the predicate and subject device is the introduction of an 8 mm screw and new instruments. This difference does not raise any new questions of safety and efficacy and is supported by the information provided in this submission. Therefore, the Integrity-SI® Fusion System is substantially equivalent to the predicate device.