Who is the manufacturer of NEXXT MATRIXX System?

Nexxt Spine, LLC filed the 510(k) submission for NEXXT MATRIXX System (K200969).

What is the FDA product code for NEXXT MATRIXX System?

MAX. It is classified under 21 CFR 888.3080 as a Class 2 device in the Orthopedic panel.

What is the regulatory pathway for NEXXT MATRIXX System?

510(k) clearance (submission type: Special).

What are the predicate devices for NEXXT MATRIXX System?

NEXXT MATRIXX® System (K171140); NEXXT MATRIXX® System (K192687); NEXXT MATRIXX® System (K193370).

Who can help prepare an FDA 510(k) submission like NEXXT MATRIXX System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

NEXXT MATRIXX System

K200969 · Nexxt Spine, LLC · MAX · May 21, 2020 · Orthopedic

Device Facts

Record ID	K200969
Device Name	NEXXT MATRIXX System
Applicant	Nexxt Spine, LLC
Product Code	MAX · Orthopedic
Decision Date	May 21, 2020
Decision	SESE
Submission Type	Special
Regulation	21 CFR 888.3080
Device Class	Class 2
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® System comprises additively manufactured titanium alloy interbody spacers for spinal stabilization. Implants feature structural frames with roughened surfaces (~7µm) and geometric lattices (300-700µm pores). ALIF and Lateral variants include large vertical cavities for packing with autograft/allograft bone graft. Devices are implanted by surgeons during spinal fusion procedures to provide structural support and facilitate fusion. Available in various heights, lengths, widths, and lordotic angles to match patient anatomy. Requires supplemental fixation. Benefits include stabilization of spinal segments in patients with degenerative conditions.

Clinical Evidence

Bench testing only. Dimensional analysis performed to verify that modified ALIF and Lateral interbody devices meet design specifications and are substantially equivalent to predicate devices.

Technological Characteristics

Additively manufactured interbody spacers; Material: Ti6Al4V ELI titanium alloy (ASTM F3001); Surface: roughened (~7µm); Porosity: 300-700µm lattice; Form factor: structural column with vertical bone graft cavity; Dimensions: variable height, length, width, and lordotic angulation.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous lumbar levels (L2-S1) with up to Grade 1 spondylolisthesis, or as an adjunct to fusion for degenerative scoliosis, following six months of failed nonoperative treatment.

Regulatory Classification

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)
NEXXT MATRIXX® System (K192687)
NEXXT MATRIXX® System (K193370)

Related Devices

K193370 — Nexxt Matrixx System · Nexxt Spine, LLC · Jan 21, 2020
K193412 — NEXXT MATRIXX System · Nexxt Spine, LLC · Feb 24, 2020
K191408 — Nexxt Matrixx System · Nexxt Spine, LLC · Jul 10, 2019
K171140 — Matrixx System · Nexxt Spine, LLC · Aug 22, 2017
K202230 — NEXXT MATRIXX Stand Alone ALIF System · Nexxt Spine, LLC · Dec 15, 2020

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. May 21, 2020 Nexxt Spine, LLC % Karen E. Warden, Ph.D. President BackRoads Consulting PO Box 566 Chesterland, Ohio 44026 Re: K200969 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: May 1, 2020 Received: May 4, 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 {1}------------------------------------------------ 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 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 medical devices and radiation-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 L. Showalter, Ph.D. Assistant Director (Acting) 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) K200969 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) | <svg fill="none" height="16" style="margin-right: 5px; vertical-align: middle;" viewbox="0 0 16 16" width="16" xmlns="http://www.w3.org/2000/svg"> <path d="M13.6 2.4L5.6 10.4L2.4 7.2L0 9.6L5.6 15.2L16 4L13.6 2.4Z" fill="black"></path> </svg> Prescription Use (Part 21 CFR 801 Subpart D) <svg fill="none" height="16" style="margin-right: 5px; vertical-align: middle;" viewbox="0 0 16 16" width="16" xmlns="http://www.w3.org/2000/svg"> </svg> 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 information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 510(k) Summary | Date: | 20 May 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 | | 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 modified anterior lumbar interbody fusion (ALIF) and Lateral interbody devices 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® ALIF and Lateral devices incorporate a large vertical cavity which can be packed with 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 Ti6Al4V ELI titanium alloy (ASTM F3001). | | Primary Predicate: | NEXXT MATRIXX® System (Nexxt Spine, LLC – K171140) | | Additional Predicates: | NEXXT MATRIXX® System (Nexxt Spine, LLC – K192687), NEXXT MATRIXX® System (Nexxt Spine, LLC - K193370) | | Performance Data: | The modified devices were evaluated via dimensional analyses. The results demonstrated the performance of the modified ALIF and Lateral interbody devices to substantially equivalent to the predicate. | | Technological Characteristics: | The modified NEXXT MATRIXX® System ALIF and Lateral devices possess 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 devices is the same as previously cleared devices. | | Conclusion: | The modified NEXXT MATRIXX® System devices possesses the same intended use and technological characteristics as the predicate devices. Therefore the modified NEXXT MATRIXX® System devices are substantially equivalent for their intended use. | {4}------------------------------------------------