← Product Code [MAX](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MAX) · K191408 # Nexxt Matrixx System (K191408) _Nexxt Spine, LLC · MAX · Jul 10, 2019 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MAX/K191408 ## Device Facts - **Applicant:** Nexxt Spine, LLC - **Product Code:** [MAX](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MAX.md) - **Decision Date:** Jul 10, 2019 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 888.3080 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended 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. ## Device Story Nexxt Matrixx® rTLIF is an additively manufactured interbody fusion spacer; provides structural column for spinal stabilization. Device features external structural frame with roughened surface (~7µm) and internal geometric lattices (pores 300-700µm). Large vertical cavity allows packing with autograft or allograft bone graft. Available in various heights, lengths, widths, and lordotic angles to match patient anatomy. Used by surgeons in clinical settings to facilitate fusion in lumbar spine; requires supplemental fixation. Benefits include stabilization of spinal segments and promotion of bone fusion. ## Clinical Evidence Bench testing only. Performance evaluated via finite element analyses and dynamic axial compression testing per ASTM F2077. Results demonstrate performance equivalent to predicate devices. ## Technological Characteristics Additively manufactured interbody spacer; material: Ti-6Al-4V ELI titanium alloy (ASTM F3001). Features roughened surface (~7µm) and geometric lattice pores (300-700µm). Dimensions comparable to cleared devices. No software or electronic components. ## Regulatory 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. ## Special Controls *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. ## Predicate Devices - NEXXT MATRIXX® System ([K171140](/device/K171140.md)) - Cascadia Interbody System ([K172009](/device/K172009.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ July 10, 2019 Image /page/0/Picture/1 description: The image shows the logo for 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, and then the word "ADMINISTRATION" in a smaller font size below that. 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 {1}------------------------------------------------ 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 {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) 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) | | | CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ***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: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 510(k) Summary | Date: | 24 May 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 a steerable TLIF interbody device to the NEXXT
MATRIXX® System. | | Device Description: | 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. | | 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-6Al-4V ELI titanium
alloy (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 and
Dynamic Axial Compression per ASTM F2077. The results demonstrated
the performance of the modified TLIF is substantially equivalent to the
predicate. | | Technological
Characteristics: | The modified NEXXT MATRIXX® System rTLIF 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 rTLIF is the same as previously cleared devices. | | Conclusion: | The modified NEXXT MATRIXX® System rTLIF possesses the same
intended use and technological characteristics as the predicate devices.
Therefore the modified NEXXT MATRIXX® System rTLIF is substantially
equivalent for its intended use. | {4}------------------------------------------------ --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MAX/K191408](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/MAX/K191408) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com