(104 days)
No
The 510(k) summary describes a mechanical implant system and its performance is evaluated through mechanical testing. There is no mention of AI/ML in the intended use, device description, or performance studies.
Yes.
The device is intended for sacroiliac joint fusion and fixation, which are therapeutic interventions for managing conditions like degenerative sacroiliac joint disruptions and fractures.
No
The Eminent Spine SI Screw System is described as a system of screws and optional locking crowns/fangs intended for fixation and fusion of the sacroiliac joint, which is a therapeutic rather than diagnostic function.
No
The device description explicitly details physical hardware components (screws, locking crowns/fangs) made from titanium alloys, and the performance studies involve mechanical testing of these physical components.
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 Eminent Spine SI Screw System is a surgical implant designed to fuse the sacroiliac joint. It is a physical device implanted into the body.
- Intended Use: The intended use is for surgical fusion and stabilization of the sacroiliac joint, not for testing biological samples.
The provided information clearly describes a surgical implant, not a device used for in vitro testing.
N/A
Intended Use / Indications for Use
The Eminent Spine Sl Screw System is intended for sacroiliac joint fusion for conditions including degenerative sacroillitis and sacroiliac joint disruptions, to augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion and acute, non-acute, and non-traumatic fractures involving the sacroiliac joint. This includes those whose symptoms began during pregnancy or in the period and have persisted postpartum for more than 6 months.
Product codes
OUR
Device Description
The Eminent Spine Sacroiliac (SI) Screw System is intended for sacroiliac joint fixation for conditions including degenerative sacroiliac joint disruption. The Eminent Spine SI Screw System consists of screws manufactured from Ti-6Al-4V ELI per ASTM F136 using traditional machining methods, as well as 3D-printed titanium alloy Ti-6AI-4V ELI per ASTM F3001. The screws are available in a variety of lengths and diameters to accommodate varying patient anatomy. The cannulated screws have open and porous graft windows for the Ø8.5, Ø10.0, Ø11.5, and Ø13.0mm options to allow bone growth through the implant. Optional locking crowns/locking fangs are included for all of the available screw diameters to aid in conforming to patient anatomy.
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)
Substantial equivalence is supported by the results of mechanical testing which includes static torsion, driving torque, and axial pullout testing per ASTM F3574, and static and dynamic cantilever bend testing per ASTM F3574. Results support that the strength of the subject SI Screw System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Entasis 3D Dual-Lead Sacroiliac Implant System (K223708)
Reference Device(s)
T-FIX® 3DSI Joint Fusion System (K214123)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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June 4, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.
Eminent Spine, LLC % Chhavy Tep-Cullison Regulatory Affairs Specialist Jalex Medical 27865 Clemens Road, Suite 3 Westlake. Ohio 44145
Re: K240505
Trade/Device Name: Eminent Spine 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: February 21, 2024 Received: May 13, 2024
Dear Chhavy Tep-Cullison:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
Sincerely, Colin O'neill -S
Colin O'Neill, MBE 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
Submission Number (if known)
Device Name
Eminent Spine SI Screw System
Indications for Use (Describe)
The Eminent Spine Sl Screw System is intended for sacroiliac joint fusion for conditions including degenerative sacroillitis and sacroiliac joint disruptions, to augment immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion and acute, non-acute, and non-traumatic fractures involving the sacroiliac joint. This includes those whose symptoms began during pregnancy or in the period and have persisted postpartum for more than 6 months.
Type of Use (Select one or both, as applicable)
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 a logo for "Eminent Spine". The logo features a golden caduceus, which is a symbol of medicine, with a sword running through it. The caduceus and sword are surrounded by a golden, curved shape, resembling a laurel wreath. The text "EMINENT" is in a dark green, sans-serif font, and the text "SPINE" is in a lighter green, sans-serif font, with a line above and below the word.
510(k) Summary
| Submitted By: | Eminent Spine, LLC
2004 Ventura Dr. Suite #100
Plano, TX 75093 |
|-----------------------------|----------------------------------------------------------------------|
| Date: | 02/21/2024 |
| Contact Person: | Chhavy Tep-Cullison, Regulatory Affairs Specialist |
| Contact Telephone: | (440) 320-4338 |
| Contact Fax: | (440) 933-7839 |
| Device Trade Name: | Eminent Spine SI Screw System |
| Device Classification Name: | Smooth or threaded metallic bone fixation fastener (21 CFR 888.3040) |
| Device Classification: | Class II |
| Reviewing Panel: | Orthopedic |
| Product Code: | OUR |
| Predicate Device: | Entasis 3D Dual-Lead Sacroiliac Implant System (K223708) |
| Reference Device: | T-FIX® 3DSI Joint Fusion System (K214123) |
Device Description:
The Eminent Spine Sacroiliac (SI) Screw System is intended for sacroiliac joint fixation for conditions including degenerative sacroiliac joint disruption. The Eminent Spine SI Screw System consists of screws manufactured from Ti-6Al-4V ELI per ASTM F136 using traditional machining methods, as well as 3D-printed titanium alloy Ti-6AI-4V ELI per ASTM F3001. The screws are available in a variety of lengths and diameters to accommodate varying patient anatomy. The cannulated screws have open and porous graft windows for the Ø8.5, Ø10.0, Ø11.5, and Ø13.0mm options to allow bone growth through the implant. Optional locking crowns/locking fangs are included for all of the available screw diameters to aid in conforming to patient anatomy.
Indications for Use:
The Eminent Spine SI Screw System is intended for sacroiliac joint fusion for conditions including degenerative sacroilitis and sacroiliac joint disruptions, to augment immobilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion and acute, and non-traumatic fractures involving the sacroiliac joint. This includes those whose symptoms began during pregnancy or in the period and have persisted postpartum for more than 6 months.
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Image /page/4/Picture/0 description: The image is a logo for Eminent Spine. The logo features a golden caduceus with a sword through it, surrounded by a golden circle with green accents. Below the image is the word "EMINENT" in green, with the word "SPINE" in a smaller font below it.
Summary of Technological Characteristics:
The Eminent Spine SI Screw System and the predicate system both have the same intended use and fundamental scientific technology. A comparison table of the subject device and predicate device technological characteristics is provided in this submission in Section 005 Substantial Equivalence. A condensed comparison table is also presented below. There are no differences in technological characteristics that raise questions of safety and efficacy.
| Item | Subject Device:
Eminent Spine SI Screw System | Predicate Device:
Entasis 3D Dual-Lead Sacroiliac
Implant System (K223708) | Comparison |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Classification
Name | Smooth or threaded metallic bone
fixation fastener | Smooth or threaded metallic bone
fixation fastener | Same |
| Regulation | 21 CFR 888.3040 | 21 CFR 888.3040 | Same |
| Product Code | OUR | OUR, HWC | Same |
| Indications for
Use | The Eminent Spine SI System is
intended for sacroiliac joint fusion for
conditions including degenerative
sacroiliitis and sacroiliac joint
disruptions, to augment
immobilization and stabilization of the
sacroiliac joint in skeletally mature
patients undergoing sacropelvic
fixation as part of a lumbar or
thoracolumbar fusion and acute, non-
acute, and non-traumatic fractures
involving the sacroiliac joint. This
includes those whose symptoms began
during pregnancy or in the peripartum
period and have persisted postpartum
for more than 6 months. | The Entasis 3D Dual-Lead Sacroiliac
Implant System is intended for
sacroiliac joint fusion for conditions
including degenerative sacroiliitis and
sacroiliac joint disruptions, to
augment immobilization and
stabilization of the sacroiliac joint in
skeletally mature patients undergoing
sacropelvic fixation as part of a
lumbar or thoracolumbar fusion and
acute, non-acute, and non-traumatic
fractures involving the sacroiliac joint.
This includes those whose symptoms
began during pregnancy or in the
peripartum period and have persisted
postpartum for more than 6 months. | Same |
| Screw
Lengths | 20 - 90 mm in 5 mm increments | Machined: 30-70mm in 5mm
increments
3D-Printed: 30-110mm in 5mm
increments | Substantially
Equivalent |
| Screw
Diameters | Ø8.5, Ø10.0, Ø11.5, Ø13.0 mm | Machined: Ø7.0, Ø9.5, Ø11.5 mm
3D-Printed: Ø9.5, Ø11.5, Ø14.5 mm | Substantially
Equivalent |
| Material | Ti-6Al-4V ELI per ASTM F136
Ti-6Al-4V per ASTM F3001 | Ti-6Al-4V ELI per ASTM F136
Ti-6Al-4V per ASTM F3001 | Same |
Table 1: Dimensions and Technological Characteristics Comparison
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Image /page/5/Picture/0 description: The image shows a logo for Eminent Spine. The logo features a golden sword with a caduceus wrapped around it, set within a golden oval. Below the emblem, the word "EMINENT" is written in a serif font, with the word "SPINE" underneath in a smaller font.
Non-Clinical Testing:
Substantial equivalence is supported by the results of mechanical testing which includes static torsion, driving torque, and axial pullout testing per ASTM F3574, and static and dynamic cantilever bend testing per ASTM F3574. Results support that the strength of the subject SI Screw System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
Conclusion:
Based on the indications for use, technological characteristics, and comparison with the predicate device, the subject device has demonstrated substantial equivalence.