(9 days)
Not Found
No
The description focuses on the mechanical components (plates and screws) and their intended use for spinal fixation, with no mention of AI or ML technologies.
Yes
The device is described as an implant system for anterior screw fixation of the cervical spine, intended to provide stabilization as an adjunct to cervical fusion for various medical conditions, indicating a therapeutic purpose.
No
This device, the Struxxure® System, is an implantable system (plates and screws) intended for stabilization and fusion of the cervical spine. Its purpose is to physically support and fix the spine, not to identify or diagnose medical conditions.
No
The device description explicitly states that the device consists of "plates and screws," which are physical hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description clearly states the Struxxure® System consists of "plates and screws" intended for "anterior screw fixation of the cervical spine." These are physical implants used within the body during surgery.
- Intended Use: The intended use is for "stabilization as an adjunct to cervical fusion," which is a surgical procedure.
The information provided describes a surgical implant, not a device used for testing biological samples outside the body.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine
Indicated Patient Age Range
Not Found
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)
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.
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
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.
0
March 22, 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: on the left, there is the Department of Health & Human Services logo, which features a stylized eagle. To the right of the eagle is the FDA logo, with the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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).
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, 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.
4
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)