(43 days)
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.
The NEXXT MATRIXX® rTLIF is a collection of additively manufactured spacers for lumbar/lumbosacral 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 autograft or allograft comprised of cancellous and/or corticocancellous bone graft material. The 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.
The provided text is a 510(k) summary for a medical device (Nexxt Matrixx® System) and does not describe a study involving an AI or software-based medical device. Therefore, I cannot extract the information required to answer your prompt.
The document discusses a physical interbody fusion device and its substantial equivalence to a predicate device based primarily on mechanical performance testing (finite element analyses and Dynamic Axial Compression per ASTM F2077). It does not mention any artificial intelligence (AI) or machine learning components, nor does it describe a study involving human readers or the establishment of ground truth for a test set in the context of an AI device.
Therefore, I cannot populate the requested information.
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July 10, 2019
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Nexxt Spine LLC % Karen Warden, PhD President BackRoads Consulting PO Box 566 Chesterland, Ohio 44026
Re: K191408
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: June 28, 2019 Received: July 1, 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 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
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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 (QS) 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.
for Melissa Hall 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) K191408
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) | X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) | X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|---|---|
| X 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: | 24 May 2019 |
|---|---|
| Sponsor: | Nexxt Spine, LLC14425 Bergen Blvd, Suite BNoblesville, IN 46060Office: 317.436.7801Fax: 317.245.2518 |
| Sponsor Contact: | Andy Elsbury, President |
| 510(k) Contact: | Karen E. Warden, PhDBackRoads Consulting Inc.PO Box 566Chesterland, OH 44026Office: 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 a steerable TLIF interbody device to the NEXXTMATRIXX® System. |
| Device Description: | The NEXXT MATRIXX® rTLIF is a collection of additively manufacturedspacers for lumbar/lumbosacral implantation. The basic shape of theseimplants is a structural column to provide surgical stabilization of the spine.Each device comprises an external structural frame having a roughenedsurface (~7µm). The intervening geometric lattices have pores 300-700µm.The inferior/superior aspects of the NEXXT MATRIXX® open devicesincorporate a large vertical cavity which can be packed with autograft orallograft comprised of cancellous and/or corticocancellous bone graftmaterial. The devices are available in an assortment of height, length, widthand lordotic angulation combinations to accommodate the individualanatomic 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 thelumbar spine, from L2-S1, in skeletally mature patients who have had sixmonths of non-operative treatment for the treatment of degenerative discdisease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined asback pain of discogenic origin with degeneration of the disc confirmed byhistory and radiographic studies. Additionally, the NEXXT MATRIXX®lumbar implants can be used as an adjunct to fusion in patients diagnosedwith degenerative scoliosis. The device is intended for use with autograftand/or allograft comprised of cancellous and/or corticocancellous bone graftand with supplemental fixation. |
| Materials: | NEXXT MATRIXX® implants are manufactured from Ti-6Al-4V ELI titaniumalloy (ASTM F3001). |
| Primary Predicate: | NEXXT MATRIXX® System (Nexxt Spine, LLC - K171140) |
| Additional Predicates: | Cascadia Interbody System (K2M Inc. - K172009) |
| Performance Data: | The modified rTLIF device was evaluated via finite element analyses andDynamic Axial Compression per ASTM F2077. The results demonstratedthe performance of the modified TLIF is substantially equivalent to thepredicate. |
| TechnologicalCharacteristics: | The modified NEXXT MATRIXX® System rTLIF possesses the sametechnological characteristics as one or more of the predicate devices. Theseinclude:• performance (as described above),• basic design (additively manufactured structural interbody),• material (titanium alloy) and• size (dimensions are comparable to those offered by the cleareddevices).Therefore the fundamental scientific technology of the modified NEXXTMATRIXX® System rTLIF is the same as previously cleared devices. |
| Conclusion: | The modified NEXXT MATRIXX® System rTLIF possesses the sameintended use and technological characteristics as the predicate devices.Therefore the modified NEXXT MATRIXX® System rTLIF is substantiallyequivalent for its intended use. |
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N/A