(87 days)
The NEXXT MATRIXX® Stand Alone Cervical System is a stand-alone anterior cervical interbody fusion system intended for use as an adjunct to fusion at one or two contiguous levels (C2-T1) in skeletally mature patients for the treatment of degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confirmed by history and radiographic studies). These patients should have received at least six weeks of nonoperative treatment prior to treatment with the device. The NEXXT MATRIXX® Stand Alone Cervical System is to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and implanted via an open, anterior approach. The NEXXT MATRIXX® Stand Alone Cervical System is intended to be used with the bone screw fixation provided and requires no additional fixation.
NEXXT MATRIXX® is a collection of additively manufactured implants. The Stand Alone Cervical System includes additively manufactured spacer and traditionally machined fixation screw implants. The spacer and screw components are available in an assortment of dimensional combinations to accommodate the individual anatomic and clinical circumstances of each patient. The basic shape of the spacer 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 300-700µm pores. The inferior/superior aspects of the spacer incorporates a vertical cavity which can be packed with bone graft material. Each fixation screw is preassembled to a locking collet which secures the spacer and screw components.
This FDA 510(k) summary is for the NEXXT MATRIXX® Stand Alone Cervical System, an intervertebral body fusion device. It primarily focuses on demonstrating substantial equivalence to predicate devices through mechanical testing and comparison of technological characteristics, rather than clinical performance or diagnostic accuracy. Therefore, many of the requested categories related to clinical study design and performance metrics (like sensitivity, specificity, or human reader improvement with AI) are not applicable or detailed in this document.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are based on demonstrating substantial equivalence to legally marketed predicate devices, primarily through mechanical performance and technological characteristics. The document implies that the device's performance should be comparable to or exceed that of the predicates in relevant mechanical tests.
| Acceptance Criteria Category | Specific Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Resistance to subsidence, static and dynamic compression, static and dynamic compression shear, static and dynamic torsion according to ASTM F2267 and ASTM F2077. Screw pushout properties. (Expected to be comparable to predicate devices to ensure safety and effectiveness for spinal fusion). | "The mechanical test results demonstrate that Stand Alone Cervical System performance is substantially equivalent to the predicate devices." (Specific values are not provided in this summary, but the conclusion is that it met the equivalence threshold.) |
| Technological Characteristics | Intended Use, basic design (additively manufactured structure and integrated fixation), material (titanium alloy), and sizes (dimensions). (Expected to be the same or very similar to predicate devices). | "The NEXXT MATRIXX® Stand Alone Cervical System possesses the same technological characteristics as one or more of the predicate devices. These include: intended use (as described above), basic design (additively manufactured structure and integrated fixation), material (titanium alloy) and sizes (dimensions are comparable to those offered by the predicate systems)." |
| Material Composition | Spacers and fixation screws manufactured from Ti-6Al-4V ELI titanium alloy per ASTM F3001 and F136, respectively. (Expected to meet these material standards for biocompatibility and strength.) | "NEXXT MATRIXX® Stand Alone Cervical System spacers and fixation screws are manufactured from Ti-6Al-4V ELI titanium alloy per ASTM F3001 and F136, respectively." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a "sample size" in terms of patient numbers, as the primary testing described is mechanical. For mechanical testing, the "samples" would be individual devices or components tested. The exact number of devices tested for each mechanical test is not provided in this summary.
- Data Provenance: Not applicable in the context of clinical patient data. The mechanical testing would have been conducted in a laboratory setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is an implantable medical device, and its approval is based on mechanical performance and design specifications, not on expert interpretation of diagnostic images or clinical outcomes that require ground truth establishment by experts in the same way an AI diagnostic device would.
4. Adjudication Method for the Test Set
Not applicable, as there is no "test set" in the context of expert review for diagnostic ground truth. The mechanical testing results would be compared against predefined standards (ASTM standards and predicate device performance).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. This is a medical implant, not a diagnostic AI device requiring an MRMC study to compare human reader performance with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in the sense that the mechanical tests represent the "standalone" physical performance of the device without human intervention during its function in the body. The tests evaluate the device itself.
7. The Type of Ground Truth Used
The "ground truth" for this device's acceptance is based on:
- ASTM Standards: F2267 (for intervertebral body fusion devices) and F2077 (for intervertebral body fusion device static and dynamic compression shear tests), which set objective mechanical performance requirements.
- Predicate Device Performance: The mechanical performance and technological characteristics (intended use, design, materials, sizes) were assessed for "substantial equivalence" to a primary predicate (Vertu by Spinal Elements, Inc. - K181837) and several additional predicate devices. The performance of these cleared devices establishes a benchmark for safety and effectiveness.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the full name of the agency on the right. The symbol on the left is a stylized representation of a human figure, while the FDA acronym is in blue, followed by the full name of the agency, "U.S. Food & Drug Administration," in a smaller font size.
Nexxt Spine LLC % Karen Warden, PhD President BackRoads Consulting PO Box 566 Chesterland, Ohio 44026
Re: K190546
Trade/Device Name: NEXXT MATRIXX® Stand Alone Cervical System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: March 4, 2019 Received: March 5, 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
{1}------------------------------------------------
statutes and regulations administered by other Federal agencies. You must comply with all the Act's
Page 2
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,
for CAPT Raquel Peat, PhD, MPH, USPHS Director 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)
Device Name
NEXXT MATRIXX® Stand Alone Cervical System
Indications for Use (Describe)
The NEXXT MATRIXX® Stand Alone Cervical System is a stand-alone anterior cervical interbody fusion system intended for use as an adjunct to fusion at one or two contiguous levels (C2-T1) in skeletally mature patients for the treatment of degenerative disc disease (defined as discogenic neck pain with desc confirmed by history and radiographic studies). These patients should have received at least six weeks of nonoperative treatment prior to treatment with the device. The NEXXT MATRIXX® Stand Alone Cervical System is to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and implanted via an open, anterior approach. The NEXXT MATRIXX® Stand Alone Cervical System is intended to be used with the bone screw fixation provided and requires no additional 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) |
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
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."
Paperwork Reduction Act (PRA) Staff
{3}------------------------------------------------
K190546 510(k) Summary
| Date: | 8 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 | |
| PO Box 566 | |
| Chesterland, OH 44026 | |
| Office: 440.729.8457 | |
| Proposed Trade Name: | NEXXT MATRIXX® Stand Alone Cervical System |
| Common Name: | Cervical spacer with integrated fixation |
| Device Classification: | Class II |
| Regulation Name, Regulation Number, Product Code: | Intervertebral fusion device with integrated fixation, cervical, 888.3080, OVE |
| Device Description: | NEXXT MATRIXX® is a collection of additively manufactured implants. The Stand Alone Cervical System includes additively manufactured spacer and traditionally machined fixation screw implants. The spacer and screw components are available in an assortment of dimensional combinations to accommodate the individual anatomic and clinical circumstances of each patient. The basic shape of the spacer 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 300-700µm pores. The inferior/superior aspects of the spacer incorporates a vertical cavity which can be packed with bone graft material. Each fixation screw is preassembled to a locking collet which secures the spacer and screw components. |
| Indications for Use: | The NEXXT MATRIXX® Stand Alone Cervical System is a stand-alone anterior cervical interbody fusion system intended for use as an adjunct to fusion at one or two contiguous levels (C2-T1) in skeletally mature patients for the treatment of degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confirmed by history and radiographic studies). These patients should have received at least six weeks of nonoperative treatment prior to treatment with the device. The NEXXT MATRIXX® Stand Alone Cervical System is to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone and implanted via an open, anterior approach. The NEXXT MATRIXX® Stand Alone Cervical System is intended to be used with the bone screw fixation provided and requires no additional fixation. |
| Materials: | NEXXT MATRIXX® Stand Alone Cervical System spacers and fixation screws are manufactured from Ti-6Al-4V ELI titanium alloy per ASTM F3001 and F136, respectively. |
| Primary Predicate: | Primary: Vertu (Spinal Elements, Inc. - K181837) |
{4}------------------------------------------------
| Additional Predicates: | Additional: Vault™ C (Precision Spine – K132029), MATRIXX® System(Nexxt Spine, Inc. – K171140), MC+® (LDR Spine USA – K091088), BAK/C(CenterPulse Spine-Tech - P980048), Honour® System (Nexxt Spine, Inc. –K120345), Spider Cervical Plating System (X-spine Systems – K052292),Aleutian IBF System (K2M, Inc. - K082698) |
|---|---|
| Reference Device: | Mobi-C (LDR Spine USA – P110002) |
| Performance Data: | Mechanical testing of worst case NEXXT MATRIXX® Stand Alone CervicalSystem devices included subsidence, static and dynamic compression,static and dynamic compression shear and static and dynamic torsionaccording to ASTM F2267 and ASTM F2077. In addition, the screw pushoutproperties were evaluated. |
| The mechanical test results demonstrate that Stand Alone Cervical Systemperformance is substantially equivalent to the predicate devices. | |
| TechnologicalCharacteristics: | The NEXXT MATRIXX® Stand Alone Cervical System possesses the sametechnological characteristics as one or more of the predicate devices. Theseinclude: intended use (as described above), basic design (additivelymanufactured structure and integrated fixation), material (titanium alloy) andsizes (dimensions are comparable to those offered by the predicatesystems). |
| Therefore the fundamental scientific technology of the Stand Alone CervicalSystem is the same as previously cleared devices. | |
| Conclusion: | The NEXXT MATRIXX® Stand Alone Cervical System possesses the sameintended use and technological characteristics as the predicate devices.Therefore the Stand Alone Cervical System is substantially equivalent for itsintended use. |
§ 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.