(77 days)
No
The summary describes a physical implant device and its mechanical properties, with no mention of AI or ML in its design, function, or intended use.
Yes
The device is described as replacing diseased, collapsed, damaged, or unstable vertebral bodies and restoring the integrity of the spinal column, which indicates it is used for treatment.
No
The device is described as a corpectomy device, which is an implant used to replace a diseased or damaged vertebral body. Its function is to provide structural support and stabilization to the spine, rather than to diagnose medical conditions.
No
The device description clearly states it is a collection of "additively manufactured spacers" and describes their physical characteristics and intended use as implants, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant used to replace or reconstruct vertebral bodies in the spine. This is a therapeutic and structural function within the body, not a diagnostic test performed on samples outside the body.
- Device Description: The device is described as a collection of additively manufactured spacers for spinal implantation. This aligns with a surgical implant, not a diagnostic device.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
- Performance Studies: The performance studies focus on mechanical testing (compression, torsion, subsidence, expulsion), which are relevant to the structural integrity and function of a surgical implant, not the accuracy of a diagnostic test.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The NEXXT MATRIXX® corpectomy devices do not fit this description.
N/A
Intended Use / Indications for Use
The NEXXT MATRIXX® corpectomy devices are indicated for use in the cervical spine (C2-T1) and thoracolumbar spine (T1-L5) in skeletally mature patients to replace a diseased, collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders. The NEXXT MATRIXX® corpectomy devices are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion. The NEXXT MATRIXX® corpectomy devices are intended for use with autograft or allogenic bone graft comprised of cancellous and/ or corticocancellous bone graft, as an adjunct to fusion and with FDA-cleared supplemental internal fixation.
Product codes (comma separated list FDA assigned to the subject device)
PLR, MQP
Device Description
The NEXXT MATRIXX® System is a collection of additively manufactured spacers for cervical, lumbar/lumbosacral and thoracolumbar implantation. The basic shape of these implants is a structural column to provide surgical stabilization of the spine. Each device comprises an external structural frame having a roughened surface (~7μm). The intervening geometric lattices have pores 300-700µm.
The inferior/superior aspects of the NEXXT MATRIXX® open devices incorporate a large vertical cavity which can be packed with bone graft material. The inferior/superior aspects of the NEXXT MATRIXX® solid devices are closed and do not permit the packing of bone graft within the implant. The solid devices are only to be used for partial vertebral body replacement. The open and solid devices are available in an assortment of height, length, width and lordotic angulation combinations to accommodate the individual anatomic and clinical circumstances of each patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (C2-T1), thoracolumbar spine (T1-L5)
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
Prescription Use
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 modified corpectomy device was evaluated via mechanical testing including included static and dynamic compression and static and dynamic torsion (ASTM F2077), subsidence (ASTM F2267) and expulsion. The results demonstrated the performance of the modified corpectomy is substantially equivalent to the predicate.
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.
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
Image /page/0/Picture/0 description: The image contains 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 24, 2020
Nexxt Spine LLC % Karen E. Warden, PhD President BackRoads Consulting Inc. PO Box 566 Chesterland, Ohio 44026
Re: K193412
Trade/Device Name: NEXXT MATRIXX® System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: Class II Product Code: PLR, MQP Dated: December 23, 2019 Received: December 26, 2019
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,
Brent Showalter. PhD Assistant Director (Acting) DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
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 NEXXT MATRIXX® System
Indications for Use (Describe)
The NEXXT MATRIXX® corpectomy devices are indicated for use in the cervical spine (C2-T1) and thoracolumbar spine (T1-L5) in skeletally mature patients to replace a diseased, collapsed, damaged, or unstable vertebral body due to tumor, osteomyelitis, trauma (i.e. fracture), or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in degenerative disorders. The NEXXT MATRIXX® corpectomy devices are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical, thoracic, and lumbar spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion. The NEXXT MATRIXX® corpectomy devices are intended for use with autograft or allogenic bone graft comprised of cancellous and/ or corticocancellous bone graft, as an adjunct to fusion and with FDA-cleared supplemental internal fixation.
| 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) | ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Section 7 – 510(k) Summary
| Date: | 6 December 2019 |
|---|---|
| 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 | |
| Proposed Trade Name: | NEXXT MATRIXX® System |
| Common Name: | Corpectomy device |
| Device Classification: | Class II |
| Regulation Name, | |
| Regulation Number, | |
| Product Codes: | Spinal vertebral body replacement device - Cervical, 888.3060, PLR |
| Spinal vertebral body replacement device, 888.3060, MQP | |
| Submission Purpose: | The subject 510(k) adds a vertebral body replacement (corpectomy) device |
| to the NEXXT MATRIXX® System. | |
| Device Description: | The NEXXT MATRIXX® System is a collection of additively manufactured |
| spacers for cervical, lumbar/lumbosacral and thoracolumbar implantation. | |
| The basic shape of these implants is a structural column to provide surgical | |
| stabilization of the spine. Each device comprises an external structural | |
| frame having a roughened surface (~7μm). The intervening geometric | |
| lattices have pores 300-700µm. | |
| The inferior/superior aspects of the NEXXT MATRIXX® open devices | |
| incorporate a large vertical cavity which can be packed with bone graft | |
| material. The inferior/superior aspects of the NEXXT MATRIXX® solid | |
| devices are closed and do not permit the packing of bone graft within the | |
| implant. The solid devices are only to be used for partial vertebral body | |
| replacement. The open and solid devices are available in an assortment of | |
| height, length, width and lordotic angulation combinations to accommodate | |
| the individual anatomic and clinical circumstances of each patient. | |
| Indications for Use: | The NEXXT MATRIXX® corpectomy devices are indicated for use in the |
| cervical spine (C2-T1) and thoracolumbar spine (T1-L5) in skeletally mature | |
| patients to replace a diseased, collapsed, damaged, or unstable vertebral | |
| body due to tumor, osteomyelitis, trauma (i.e. fracture), or for reconstruction | |
| following corpectomy performed to achieve decompression of the spinal | |
| cord and neural tissues in degenerative disorders. The NEXXT MATRIXX® | |
| corpectomy devices are also intended to restore the integrity of the spinal | |
| column even in the absence of fusion for a limited time period in patients | |
| with advanced stage tumors involving the cervical, thoracic, and lumbar | |
| spine in whom life expectancy is of insufficient duration to permit | |
| achievement of fusion, with bone graft used at the surgeon's discretion. The | |
| NEXXT MATRIXX® corpectomy devices are intended for use with autograft | |
| or allogenic bone graft comprised of cancellous and/or corticocancellous | |
| bone graft, as an adjunct to fusion and with FDA-cleared supplemental | |
| internal fixation. | |
| Materials: | NEXXT MATRIXX® implants are manufactured from Ti-6Al-4V ELI titanium |
| alloy (ASTM F3001). | |
| Primary Predicate: | NEXXT MATRIXX® System (Nexxt Spine, LLC – K171140) |
| Additional Predicate: | Honour System (Nexxt Spine, LLC – K120345), Capri® Corpectomy Cage |
| System (K2M Inc. – K180665) | |
| Performance Data: | The modified corpectomy device was evaluated via mechanical testing |
| including included static and dynamic compression and static and dynamic | |
| torsion (ASTM F2077), subsidence (ASTM F2267) and expulsion. The | |
| results demonstrated the performance of the modified corpectomy is | |
| substantially equivalent to the predicate. | |
| Technological | |
| Characteristics: | The modified NEXXT MATRIXX® System corpectomy possesses the same |
| technological characteristics as one or more of the predicate devices. These | |
| include: | |
| performance (as described above), basic design (additively manufactured structural interbody), material (titanium alloy) and size (dimensions are comparable to those offered by the cleared devices). Therefore the fundamental scientific technology of the modified NEXXT | |
| MATRIXX® System corpectomy is the same as previously cleared devices. | |
| Conclusion: | The modified NEXXT MATRIXX® System corpectomy possesses the same |
| intended use and technological characteristics as the predicate devices. | |
| Therefore the modified NEXXT MATRIXX® System corpectomy is | |
| substantially equivalent for its intended use. |
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