(87 days)
P110002
No
The summary describes a physical implant and its mechanical properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is described as an anterior cervical interbody fusion system intended for the treatment of degenerative disc disease and to be used as an adjunct to fusion, indicating a direct therapeutic purpose.
No
Explanation: The device is described as an anterior cervical interbody fusion system, which is a therapeutic device used for spinal fusion, not for diagnosing medical conditions. Its intended use is to treat degenerative disc disease by providing stabilization and promoting fusion, not to identify or monitor a disease.
No
The device description clearly states it is a collection of additively manufactured implants, including spacers and screws, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical implant for spinal fusion. It is used in the body to treat a physical condition (degenerative disc disease).
- Device Description: The device is described as a collection of implants (spacers and screws) made of physical materials, designed to provide structural support and facilitate bone fusion.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used outside the body to analyze biological samples. This device is implanted inside the body.
N/A
Intended Use / 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.
Product codes
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
C2-T1
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
Mechanical testing of worst case NEXXT MATRIXX® Stand Alone Cervical System devices included subsidence, static and dynamic compression, static and dynamic compression shear and static and dynamic torsion according to ASTM F2267 and ASTM F2077. In addition, the screw pushout properties were evaluated. The mechanical test results demonstrate that Stand Alone Cervical System performance is substantially equivalent to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
K181837, K132029, K171140, K091088, P980048, K120345, K052292, K082698
Reference Device(s)
P110002
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 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
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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® 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) |
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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) |
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| 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 Cervical
System devices included subsidence, static and dynamic compression,
static and dynamic compression shear and static and dynamic torsion
according to ASTM F2267 and ASTM F2077. In addition, the screw pushout
properties were evaluated. |
| | The mechanical test results demonstrate that Stand Alone Cervical System
performance is substantially equivalent to the predicate devices. |
| Technological
Characteristics: | 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). |
| | Therefore the fundamental scientific technology of the Stand Alone Cervical
System is the same as previously cleared devices. |
| Conclusion: | The NEXXT MATRIXX® Stand Alone Cervical System possesses the same
intended use and technological characteristics as the predicate devices.
Therefore the Stand Alone Cervical System is substantially equivalent for its
intended use. |