(9 days)
The Struxxure® System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or failed previous fusion.
Struxxure consists of plates and screws in a variety of sizes. Plates from 1- to 5-levels are offered. Fixed and variable angle screws are available in two diameters in both self-drilling versions. This submission adds additional 1-level plate options to the Struxxure Anterior Cervical Plate System.
The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the "STRUXXURE® MCS Anterior Cervical Plate System." This document primarily focuses on demonstrating substantial equivalence to a predicate device based on mechanical testing and a comparison of intended use, indications for use, basic design, and materials.
Crucially, this document does NOT describe the performance of software or an AI-powered device, nor does it detail a clinical study involving human readers or the establishment of ground truth for such a device. The acceptance criteria and study information requested in your prompt (related to AI/software performance) are not applicable to the content provided.
The document discusses:
- Device: STRUXXURE® MCS Anterior Cervical Plate System, which is an implantable medical device (plates and screws) for anterior cervical spinal fixation.
- Purpose of Submission: To demonstrate substantial equivalence to a legally marketed predicate device (STRUXXURE® Anterior Cervical Plate System) to allow the new device to be marketed.
- Testing: Mechanical tests were performed on the "worst case subject plate per ASTM F1717: static compression bending, static torsion, and dynamic compression bending."
- Conclusion: The tests demonstrated "substantially equivalent mechanical performance of the subject plates as compared to legally marketed predicates."
Therefore, I cannot provide the information requested in your prompt using the provided text because it does not pertain to the performance of a software or AI device. The document is about the physical characteristics and mechanical performance of a spinal implant.
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March 22, 2024
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Nexxt Spine % Jeannie Cecka President Cecka Consulting Group 163 Alvarado Rd Berkeley, California 94705
Re: K240690
Trade/Device Name: STRUXXURE® MCS Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: March 13, 2024 Received: March 13, 2024
Dear Jeannie Cecka:
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).
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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, 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
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Indications for Use
Submission Number (if known)
Device Name
STRUXXURE® MCS Anterior Cervical Plate System
Indications for Use (Describe)
The Struxxure® System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stabilization as an adjunct to cervical fusion. Indications for the use of this implant system include degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), tumor, pseudarthrosis or failed previous fusion.
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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K240690 - Page 1 of 2
510(k) Summary
Prepared on: 2024-03-15
Contact Details
| Contact Details | 21 CFR 807.92(a)(1) |
|---|---|
| Applicant Name | Nexxt Spine |
| Applicant Address | 14425 Bergen Blvd, Suite B Noblesville IN 46060 United States |
| Applicant Contact Telephone | 317.436.7801 |
| Applicant Contact | Mr. Andy Elsbury |
| Applicant Contact Email | aelsbury@nexxtspine.com |
| Correspondent Name | Cecka Consulting Group |
| Correspondent Address | 163 Alvarado Rd Berkeley CA 94705 United States |
| Correspondent Contact Telephone | 510.685.6004 |
| Correspondent Contact | Ms. Jeannie Cecka |
Correspondent Contact Email
Device Name
21 CFR 807.92(a)(2)
| Device Trade Name | STRUXXURE® MCS Anterior Cervical Plate System |
|---|---|
| Common Name | Spinal intervertebral body fixation orthosis |
| Classification Name | Appliance, Fixation, Spinal Intervertebral Body |
| Regulation Number | 888.3060 |
| Product Code(s) | KWQ |
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) |
Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code STRUXXURE® Anterior Cervical Plate System K133475 KWQ 21 CFR 807.92(a)(4)
Device Description Summary
Struxxure consists of plates and screws in a variety of sizes. Plates from 1- to 5-levels are offered. Fixed and variable angle screws are available in two diameters in both self-drilling versions. This submission adds additional 1-level plate options to the Struxxure Anterior Cervical Plate System.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
The Struxure® System is intended for anterior screw fixation of the cervical spine. These implants have been designed to provide stablization as an adjunct to cervical fusions for the use of this implant system include degenerative disc disease (defined as neck pain of discogenic origin with the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), spinal stenosis, lordosis or scoliosis, tumor, pseudarthrosis or failed previous fusion.
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Indications for Use Comparison
The STRUXXURE® MCS Anterior Cervical Plate System possesses the same indications for use as the predicate devices.
Technological Comparison
The STRUXXURE® MCS Anterior Cervical Plate System possesses the same technological characteristics as the predicate devices. These include: intended use/indications for use, basic design, materials, and mechanical performance.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The following mechanical tests were performed on the worst case subject plate per ASTM F1717: static compression bending, static torsion, and dynamic compression bending. The results demonstrate the substantially equivalent mechanical performance of the subject plates as compared to legally marketed predicates.
The STRUXXURE® MCS Anterior Cervical Plate System possesses the same intended use and technological characteristics as the predicate device. Therefore the The STRUXXURE® MCS Anterior Cervical Plate System is substantially equivalent for its intended use.
21 CFR 807.92(a)(6)
21 CFR 807.92(a)(6)
21 CFR 807.92(a)(5)
N/A