(91 days)
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No
The summary describes a system of additively manufactured implants for sacroiliac joint fusion and pelvic fracture fixation, with performance studies focused on mechanical testing. There is no mention of AI, ML, image processing, or data sets typically associated with AI/ML applications in medical devices.
Yes
The device is intended for sacroiliac joint fusion and fracture fixation, which are direct treatments for medical conditions, thus making it a therapeutic device.
No
The device is described as a system of implants intended to facilitate fusion of the sacroiliac joint and for fracture fixation of the pelvis. Its stated purpose is treatment (fusion and fixation), not diagnosis.
No
The device description explicitly states it is a "collection of additively manufactured implants" made from titanium alloy, which are physical hardware components.
Based on the provided information, the NEXXT MATRIXX® SI System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the system is for sacroiliac joint fusion and fracture fixation of the pelvis. These are surgical procedures performed directly on the patient's body.
- Device Description: The device is described as a collection of implants (press-fit shafts, threaded screws, washers) made of titanium alloy. These are physical devices intended to be surgically implanted.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. The NEXXT MATRIXX® SI System is a surgical implant used for structural support and fusion within the body.
N/A
Intended Use / Indications for Use
The NEXXT MATRIXX® SI System is indicated for sacroiliac joint fusion for:
• Sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacroiliitis.
• Augmenting immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
The NEXXT MATRIXX® SI System is also indicated for fracture fixation of the pelvis, including acute, non-acute and non-traumatic fractures.
Product codes (comma separated list FDA assigned to the subject device)
OUR, HWC
Device Description
The NEXXT MATRIXX® SI System is a collection of additively manufactured implants intended to facilitate fusion of the sacroiliac joint. The NEXXT MATRIXX® SI System includes three different implants which are press-fit shafts or threaded screws including the IMPAXX SI Implant, HELIXX SI Fully Threaded Implant, and the HELIXX SI Lag Implant. The HELIXX SI Lag Implants may be used with optional HELIXX SI Modular Washers. All subject implants are manufactured from Ti-6A1-4V per ASTM F3001 or Ti-6A1-4V ELI titanium alloy per ASTM F136 and are offered in various sizes to accommodate patient anatomical needs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sacroiliac joint, pelvis
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The NEXXT MATRIXX® SI System has been tested in the following test modes:
- Static Cantilever Bending per ASTM F2193
- Dynamic Cantilever Bending per ASTM F2193
- Axial Pullout per ASTM F543
The results of this non-clinical testing show that the strength of the NEXXT MATRIXX® SI System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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
March 14, 2025
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the words "U.S. Food & Drug Administration" and "Administration" written out.
Nexxt Spine, LLC % Hannah Taggart Regulatory Associate Empirical Technologies 4628 Northpark Drive Colorado Springs, Colorado 80918
Re: K243838
Trade/Device Name: NEXXT MATRIXX® SI System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: OUR, HWC Dated: December 13, 2024 Received: December 13, 2024
Dear Hannah Taggart:
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.
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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).
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 QS 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-regulatory
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assistance/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,
Maziar Shah Mohammadi
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
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
NEXXT MATRIXX® SI System
Indications for Use (Describe)
The NEXXT MATRIXX® SI System is indicated for sacroiliac joint fusion for:
· Sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacroillitis.
· Augmenting immobilization and stabilization of the sacroiliac joint in skeletally mature patients
undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
The NEXXT MATRIXX® SI System is also indicated for fracture fixation of the pelvis, including acute, non-acute and non-traumatic fractures.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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K243838 510(K) SUMMARY
| Submitter's Name: | Nexxt Spine, LLC |
|---|---|
| Submitter's Address: | 14425 Bergen Blvd, Suite B |
| Noblesville, Indiana 46060 | |
| Submitter's Telephone: | 317.436.7801 |
| Contact Person: | Hannah Taggart, MS |
| Empirical Technologies | |
| 719-457-1152 | |
| htaggart@empiricaltech.com | |
| Image: Empirical Technologies logo | |
| Date Summary was Prepared: | December 13, 2024 |
| Trade or Proprietary Name: | NEXXT MATRIXX® SI System |
| Device Classification Name: | Sacroiliac Joint Fixation |
| Classification & Regulation #: | Class II per 21 CFR §888.3040 |
| Regulation Name: | Smooth or threaded metallic bone fastener |
| Product Code: | OUR, HWC |
| Classification Panel: | Orthopedic - Spinal (DHT6B) |
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The NEXXT MATRIXX® SI System is a collection of additively manufactured implants intended to facilitate fusion of the sacroiliac joint. The NEXXT MATRIXX® SI System includes three different implants which are press-fit shafts or threaded screws including the IMPAXX SI Implant, HELIXX SI Fully Threaded Implant, and the HELIXX SI Lag Implant. The HELIXX SI Lag Implants may be used with optional HELIXX SI Modular Washers. All subject implants are manufactured from Ti-6A1-4V per ASTM F3001 or Ti-6A1-4V ELI titanium alloy per ASTM F136 and are offered in various sizes to accommodate patient anatomical needs.
INDICATIONS FOR USE
The NEXXT MATRIXX® SI System is indicated for sacroiliac joint fusion for:
- · Sacroiliac joint dysfunction including sacroiliac joint disruption and degenerative sacroiliitis.
- · Augmenting immobilization and stabilization of the sacroiliac joint in skeletally mature patients undergoing sacropelvic fixation as part of a lumbar or thoracolumbar fusion.
The NEXXT MATRIXX® SI System is also indicated for fracture fixation of the pelvis, including acute, nonacute, and non-traumatic fractures.
TECHNOLOGICAL CHARACTERISTICS
The predicates included in this submission were selected based on the best practices described in the FDA Draft Guidance document Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission. The subject device and predicate devices have similar technological characteristics in terms of intended use, materials of manufacture, design, function, and performance. The minor differences do not raise any new issues of safety and effectiveness.
| 510k Number | Trade or Proprietary or Model Name | Manufacturer | Product Code | Predicate Type |
|---|---|---|---|---|
| K241574 | iFuse TORQ® Implant System | SI Bone | OUR, HWC, OLO | Primary |
| K193524 | iFuse Implant System | SI Bone | OUR | Additional |
| K021932 | Synthes 6.5 mm Cannulated Screw | Synthes | HWC, OUR | Additional |
Predicate Devices
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Performance Data
The NEXXT MATRIXX® SI System has been tested in the following test modes:
- Static Cantilever Bending per ASTM F2193 ●
- Dynamic Cantilever Bending per ASTM F2193 ●
- Axial Pullout per ASTM F543 ●
The results of this non-clinical testing show that the strength of the NEXXT MATRIXX® SI System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
CONCLUSION
The overall technology characteristics and mechanical performance data lead to the conclusion that the NEXXT MATRIXX® SI System is substantially equivalent to the predicate device.