(43 days)
Not Found
No
The summary describes a mechanical plate and screw system for spinal fusion and does not mention any software, algorithms, or AI/ML capabilities. The performance studies are mechanical tests, not algorithmic performance evaluations.
Yes
The device is indicated for the treatment of various spinal conditions, including fracture, tumor, degenerative disc disease, scoliosis, and spinal stenosis, which inherently involves providing therapy to patients.
No
Explanation: This device is a plate and screw system intended for the treatment of spine instability, degenerative disc disease, and other spinal conditions, indicating it is a therapeutic device rather than a diagnostic one.
No
The device description explicitly states it is a "lumbar plate and screw system" and mentions "implants," which are physical hardware components. The performance studies also focus on mechanical testing of these physical implants.
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 for diagnosis, monitoring, or screening.
- Device Description: The STRUXXURE®-L and STRUXXURE®-A Plate System is described as a "lumbar plate and screw system" used for surgical implantation to treat spine instability.
- Intended Use: The intended use is for surgical treatment of various spine conditions by providing structural support and stability. This is a therapeutic intervention, not a diagnostic test performed on a specimen.
The information provided clearly indicates this is a surgically implanted device used for treatment, not a device used to analyze biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
The STRUXXURE®-L and STRUXXURE®-A Plate System is indicated for treatment of spine instability via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the thoracolumbar (T1-L5) spine or via an anterior surgical approach below the bifurcation of the great vessels in the lumbar and lumbosacral (1-S1) spine. The indications for use include fracture (including dislocation and subluxation), turnor, degenerative disc disease (DDD, defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, spinal stenosis, spondylolisthesis, pseudarthrosis and failed previous spine surgery.
The STRUXXURE®-L System may also be attached to NEXXT MATRIXX® Lateral interbody devices. The STRUXXURE®-A Plate System may also be attached to NEXXT MATRIXX® ALIF interbody devices. In these configurations the STRUXXURE®-L and STRUXXURE®-A Plate System is used to treat skeletally mature patients having DDD at one or two contiguous levels from L2-S1 with up to Grade 1 spondylolisthesis or as an adjunct to fusion in patients diagnosed with degenerative scoliosis.
Product codes (comma separated list FDA assigned to the subject device)
KWQ
Device Description
The STRUXXURE®-L and STRUXXURE®-A Plate System is a lumbar plate and screw system. The implants are available in a variety of sizes to accommodate the individual anatomic and clinical circumstances of each patient. The implants are sold non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracolumbar (T1-L5) spine, lumbar and lumbosacral (L1-S1) spine
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)
Mechanical testing of the worst case STRUXXURE®-L and STRUXXURE®-A Plate System construct was performed according to ASTM F1717 and included static and dynamic compression and static torsion. In addition, screw backout testing and cage-plate dissociation testing were performed. The mechanical test results demonstrate that the STRUXXURE®-L and STRUXXURE®-A Plate System performance is substantially equivalent.
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
September 17, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
Nexxt Spine LLC % Karen Warden, Ph.D. President BackRoads Consulting PO Box 566 Chesterland, Ohio 44026
Re: K202192
Trade/Device Name: STRUXXURE®-L and STRUXXURE®-A Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: KWQ Dated: August 4, 2020 Received: August 5, 2020
Dear Dr. Warden:
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
1
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 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 (OS) 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. Acting 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name STRUXXURE®-L and STRUXXURE®-A Plate System
STROATORES L and STROATORES H Plate Systems
Indications for Use (Describe)
The STRUXXURE®-L and STRUXXURE®-A Plate System is indicated for treatment of spine instability via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the thoracolumbar (T1-L5) spine or via an anterior surgical approach below the bifurcation of the great vessels in the lumbar and lumbosacral (1-S1) spine. The indications for use include fracture (including dislocation and subluxation), turnor, degenerative disc disease (DDD, defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, spinal stenosis, spondylolisthesis, pseudarthrosis and failed previous spine surgery.
The STRUXXURE®-L System may also be attached to NEXXT MATRIXX® Lateral interbody devices. The STRUXXURE®-A Plate System may also be attached to NEXXT MATRIXX® ALIF interbody devices. In these configurations the STRUXXURE®-L and STRUXXURE®-A Plate System is used to treat skeletally mature patients having DDD at one or two contiguous levels from L2-S1 with up to Grade 1 spondylolisthesis or as an adjunct to fusion in patients diagnosed with degenerative scoliosis.
| 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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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3
Section 7 - 510(k) Summary
| Date: | 4 August 2020 |
|---|---|
| Sponsor: | Nexxt Spine, LLC |
| 14425 Bergen Blvd, Suite B | |
| Noblesville, IN 46060 | |
| Office: 317.436.7801 | |
| Fax: 317.245.2518 | |
| Sponsor Contact: | Andy Elsbury, President |
| 510(k) Contact: | Karen E. Warden, PhD |
| BackRoads Consulting Inc. | |
| PO Box 566 | |
| Chesterland, OH 44026 | |
| Office: 440.729.8457 | |
| Trade Name: | STRUXXURE ® -L and STRUXXURE ® -A Plate System |
| Common Name: | Lateral and anterior lumbar plate system |
| Regulatory Class: | Class II |
| Classification Name, | |
| Regulation, Product | |
| Code: | Appliance, fixation, spinal intervertebral body, 888.3060, KWQ |
| Device Description: | The STRUXXURE ® -L and STRUXXURE ® -A Plate System is a lumbar plate |
| and screw system. The implants are available in a variety of sizes to | |
| accommodate the individual anatomic and clinical circumstances of each | |
| patient. The implants are sold non-sterile. | |
| Intended Use: | The STRUXXURE ® -L and STRUXXURE ® -A Plate System is indicated for |
| treatment of spine instability via a lateral or anterolateral surgical approach | |
| above the bifurcation of the great vessels in the thoracic and thoracolumbar | |
| (T1-L5) spine or via an anterior surgical approach below the bifurcation of | |
| the great vessels in the lumbar and lumbosacral (L1-S1) spine. The | |
| indications for use include fracture (including dislocation and subluxation), | |
| tumor, degenerative disc disease (DDD, defined as back pain of discogenic | |
| origin with degeneration of the disc confirmed by patient history and | |
| radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, | |
| spondylolysis, spondylolisthesis, pseudarthrosis and failed previous spine | |
| surgery. | |
| The STRUXXURE ® -L System may also be attached to NEXXT MATRIXX ® | |
| Lateral interbody devices. The STRUXXURE ® -A Plate System may also be | |
| attached to NEXXT MATRIXX ® ALIF interbody devices. In these | |
| configurations the STRUXXURE ® -L and STRUXXURE ® -A Plate System is | |
| used to treat skeletally mature patients having DDD at one or two | |
| contiguous levels from L2-S1 with up to Grade 1 spondylolisthesis or as an | |
| adjunct to fusion in patients diagnosed with degenerative scoliosis. | |
| Materials: | The STRUXXURE ® -L and STRUXXURE ® -A Plate System is manufactured |
| from titanium alloy as described by ASTM F136. | |
| Primary Predicate: | CoreLink Lateral Plate System (CoreLink, LLC – K190016) |
| Performance Data: | Mechanical testing of the worst case STRUXXURE ® -L and STRUXXURE ® - |
| A Plate System construct was performed according to ASTM F1717 and | |
| included static and dynamic compression and static torsion. In addition, | |
| screw backout testing and cage-plate dissociation testing were performed. | |
| The mechanical test results demonstrate that the STRUXXURE ® -L and | |
| STRUXXURE ® -A Plate System performance is substantially equivalent. |
4
| Technological
Characteristics: | The STRUXXURE®-L and STRUXXURE®-A Plate System has the same
technological characteristics as the predicate devices. These include basic
design, material, method of stabilization and anatomic location. Therefore
the fundamental scientific technology of the STRUXXURE®-L and
STRUXXURE®-A Plate System is the same as previously cleared devices. |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion: | The STRUXXURE®-L and STRUXXURE®-A Plate System possesses the
same intended use and technological characteristics as the predicate
devices. Therefore the STRUXXURE®-L and STRUXXURE®-A Plate
System is substantially equivalent for its intended use. |