(24 days)
Not Found
No
The device description focuses solely on the physical characteristics and materials of the implants. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended for sacroiliac joint fusion and addresses conditions like sacroiliac joint dysfunction. It provides stability for joint arthrodesis, which are direct therapeutic interventions.
No
This device is a surgical implant designed for sacroiliac joint fusion, providing stability for joint arthrodesis. It treats conditions rather than diagnosing them.
No
The device description explicitly details physical implants (screws, fasteners) made of titanium, indicating it is a hardware-based medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The Integrity-SI Fusion System is a system of surgical implants (screws) designed to be inserted into the sacroiliac joint to provide stability.
- Intended Use: The intended use is for the surgical fusion of the sacroiliac joint to treat specific conditions. This is a surgical procedure, not a diagnostic test performed on a sample.
The device is a surgical implant used in vivo (within the body) for treatment, not a device used in vitro (in a lab) for diagnosis.
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 sacroiliitis. 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 10mm and 12mm diameter screws are offered in partially and fully threaded version in lengths from 40-110mm, in 5mm increments. All fastener 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 fasteners are offered for additional rotational stability in lengths of 30 - 70 mm, in 5mm increments and are only intended for use in conjunction with a primary 10mm or 12mm screw.
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)
There were no changes in the design, materials, sterilization, or manufacturing methods of the device. Therefore, no new performance data was required to demonstrate the substantial equivalence of the subject device to the predicate device.
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
September 12, 2022
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left and features a stylized eagle. The FDA logo is on the right and features the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
OsteoCentric Technologies % Mr. Ken Riordan Regulatory Project Manager Telos Partners, LLC 2850 Frontier Drive Warsaw, Indiana 46582
Re: K222512
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 17, 2022 Received: August 19, 2022
Dear Mr. Riordan:
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 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,
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)
K222512
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 sacroiliitis. 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: Ken Riordan, Regulatory Project Manager, Telos Partners, LLC
Date Prepared: August 11, 2022
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
Substantial equivalence is claimed to the following devices:
- CoorsTek Integrity-SI Fusion System, K161755 (Primary Predicate)
- SI-BONE iFuse Implant System, K193524 ●
Device Description IV.
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 10mm and 12mm diameter screws are offered in partially and fully threaded version in lengths from 40-110mm, in 5mm increments. All fastener 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 fasteners are offered for additional rotational stability in lengths of 30 - 70 mm, in 5mm increments and are only intended for use in conjunction with a primary 10mm or 12mm screw.
4
Indications for Use V.
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 technological characteristics of the OsteoCentric Integrity-SI Fusion System. The device is identical to the predicate device with respect to the design, materials, sterilization, and manufacturing methods. The change to the Indications for Use does not change the intended use of the device, does not introduce new indications, and does not change the therapeutic effect or use of the implants.
VII. Performance Data
There were no changes in the design, materials, sterilization, or manufacturing methods of the device. Therefore, no new performance data was required to demonstrate the substantial equivalence of the subject device to the predicate device.
VIII. Conclusion
The technological characteristics and intended use have not changed compared to the predicate device. Therefore, the OsteoCentric Integrity-SI Fusion System is substantially equivalent to the predicate device.