(47 days)
Not Found
No
The description focuses on the physical characteristics and intended use of a spinal implant, with no mention of AI or ML capabilities.
Yes
The device is indicated for the treatment of degenerative disc disease and degenerative scoliosis, which are medical conditions that cause pain or dysfunction. The device acts by providing surgical stabilization of the spine and promoting fusion, thereby treating or alleviating the symptoms of these conditions.
No
The device is described as an implantable spinal fusion device, not a tool for diagnosing medical conditions. It uses radiographic studies for confirmation of degeneration, not as a diagnostic output itself.
No
The device description clearly describes a physical implant (additively manufactured spacers) intended for surgical implantation, not a software-only product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description and Intended Use: The Nexxt Matrixx® device is a surgical implant designed to be placed within the lumbar spine to facilitate fusion. It is a physical device used in vivo (within the body) during surgery, not a device used to test samples in vitro (outside the body).
- Input: The input mentioned is "radiographic studies," which are imaging techniques used to visualize the spine, not biological specimens for testing.
- Performance Studies: The performance studies described involve dimensional analyses of the implant itself, not the analysis of biological samples.
The Nexxt Matrixx® is a medical device, specifically a surgical implant, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
When used as a lumbar intervertebral fusion device, the Nexxt Matrixx® open devices are indicated for use at one or two contiguous levels in the lumbar spine, from L2-S1, in skeletally mature patients who have had six months of nonoperative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radios. Additionally, the Nexxt Matrixx® lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The device is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft and with supplemental fixation.
Product codes (comma separated list FDA assigned to the subject device)
MAX
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
lumbar spine, from L2-S1
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)
The modified ALIF device was evaluated via dimensional analyses. The results demonstrated the performance of the modified ALIF 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.
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
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
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.
January 21, 2020
Nexxt Spine, LLC % Karen E. Warden, PhD President BackRoads Consulting Inc. PO Box 566 Chesterland, Ohio 44026
Re: K193370
Trade/Device Name: Nexxt Matrixx® System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: MAX 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
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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 Nexxt Matrixx® System
Indications for Use (Describe)
When used as a lumbar intervertebral fusion device, the Nexxt Matrixx® open devices are indicated for use at one or two contiguous levels in the lumbar spine, from L2-S1, in skeletally mature patients who have had six months of nonoperative treatment for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radios. Additionally, the Nexxt Matrixx® lumbar implants can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis. The device is intended for use with autograft comprised of cancellous and/or corticocancellous bone graft and with supplemental 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) |
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510(k) Summary
| Date: | 4 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: | Interbody fusion system |
| Device Classification: | Class II |
| Regulation Name, | |
| Regulation Number, | |
| Product Code: | Intervertebral fusion device with bone graft, lumbar, 888.3080, MAX |
| Submission Purpose: | The subject 510(k) adds an anterior lumbar interbody fusion (ALIF) 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: | When used as a lumbar intervertebral fusion device, the NEXXT MATRIXX® |
| open devices are indicated for use at one or two contiguous levels in the | |
| lumbar spine, from L2-S1, in skeletally mature patients who have had six | |
| months of non-operative treatment for the treatment of degenerative disc | |
| disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as | |
| back pain of discogenic origin with degeneration of the disc confirmed by | |
| history and radiographic studies. Additionally, the NEXXT MATRIXX® | |
| lumbar implants can be used as an adjunct to fusion in patients diagnosed | |
| with degenerative scoliosis. The device is intended for use with autograft | |
| and/or allograft comprised of cancellous and/or corticocancellous bone graft | |
| and with supplemental fixation. | |
| Materials: | NEXXT MATRIXX® implants are manufactured from Ti-6AI-4V ELI titanium |
| alloy (ASTM F3001). | |
| Primary Predicate: | NEXXT MATRIXX® System (Nexxt Spine, LLC - K171140) |
| Additional Predicates: | Cascadia Interbody System (K2M Inc. - K172009) |
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| Performance Data: | The modified ALIF device was evaluated via dimensional analyses. The results demonstrated the performance of the modified ALIF is substantially equivalent to the predicate. |
|---|---|
| Technological | |
| Characteristics: | The modified NEXXT MATRIXX® System ALIF 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 ALIF is the same as previously cleared devices. | |
| Conclusion: | The modified NEXXT MATRIXX® System ALIF possesses the same intended use and technological characteristics as the predicate devices. Therefore the modified NEXXT MATRIXX® System ALIF is substantially equivalent for its intended use. |