(130 days)
Not Found
No
The 510(k) summary describes a mechanical implant system for spinal fusion and does not mention any software, algorithms, or AI/ML capabilities. The performance studies focus on mechanical testing.
Yes
The device is an anterior lumbar interbody fusion system intended for treatment of degenerative disc disease, which qualifies it as a therapeutic device.
No
The device is described as an interbody fusion system intended for surgical stabilization of the spine, and not for diagnosing a condition.
No
The device description clearly states it is a collection of additively manufactured implants, including interbody and fixation screw implants, which are physical hardware components.
Based on the provided information, the NEXXT MATRIXX® Stand Alone ALIF System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes a surgical implant used for spinal fusion. It is a device implanted into the body to provide structural support and facilitate bone growth.
- Device Description: The description details a physical implant made of additively manufactured and machined components. It is a tangible device used in a surgical procedure.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. The NEXXT MATRIXX® device does not perform any such analysis of biological specimens.
- Performance Studies: The performance studies described are mechanical tests evaluating the physical properties and strength of the implant, not analytical performance related to biological samples.
In summary, the NEXXT MATRIXX® Stand Alone ALIF System is a surgical implant, not a device used for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The NEXXT MATRIXX® Stand Alone ALIF System is a stand-alone anterior lumbar interbody fusion system intended for use as an adjunct to fusion at one or two contiguous levels (L2-S1) in skeletally mature patients for the treatment of degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). These patients may also have up to Grade I spondylolisthesis at the involved levels and should have received at least six months of nonoperative treatment with the device. The NEXXT MATRIXX® Stand Alone ALIF System is to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone. Hyperlordotic interbody devices (>20° lordosis) must be used with supplemental fixation (e.g. posterior fixation). Each interbody fusion device having a lordotic angle 20º or less is intended to be used with the bone screws provided and requires no additional fixation.
Product codes (comma separated list FDA assigned to the subject device)
OVD
Device Description
NEXXT MATRIXX® is a collection of additively manufactured implants. The Stand Alone ALIF System includes additively manufactured interbody and traditionally machined fixation screw implants. The interbody 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 interbody 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 interbody incorporates a vertical cavity which can be packed with bone graft material. Each interbody is preassembled with turn lock mechanisms which secure the screws to the interbody component.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lumbar (L2-S1)
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Mechanical testing of worst case NEXXT MATRIXX® Stand Alone ALIF System devices included subsidence, static and dynamic compression, and static and dynamic compression shear according to ASTM F2267 and ASTM F2077. In addition, expulsion and screw pushout properties were evaluated. The mechanical test results demonstrate that Stand Alone ALIF System performance is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
AXTI™ Titanium Stand-Alone ALIF System (Innovasis, Inc. - K182139)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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Image /page/0/Picture/0 description: The image contains 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 in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" on the bottom.
December 15, 2020
Nexxt Spine LLC % Karen Warden, Ph.D. President BackRoads Consulting PO Box 566 Chesterland, Ohio 44026
Re: K202230
Trade/Device Name: NEXXT MATRIXX® Stand Alone ALIF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVD Dated: November 18, 2020 Received: November 19, 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.
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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 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 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)
Device Name NEXXT MATRIXX® Stand Alone ALIF System
Indications for Use (Describe)
The NEXXT MATRIXX® Stand Alone ALIF System is a stand-alone anterior lumbar interbody fusion system intended for use as an adjunct to fusion at one or two contiguous levels (L2-S1) in skeletally mature patients for the treatment of degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies). These patients may also have up to Grade I spondylolisthesis at the involved levels and should have received at least six months of nonoperative treatment with the device. The NEXXT MATRIXX® Stand Alone ALIF System is to be used with autograft bone graft and/or allogeneic bone graft composed of cancellous and/or corticocancellous bone. Hyperlordotic interbody devices (>20° lordosis) must be used with supplemental fixation (e.g. posterior fixation). Each interbody fusion device having a lordotic angle 20º or less is intended to be used with the bone screws 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.
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510(k) Summary
| Date: | 7 August 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® Stand Alone ALIF System |
| Common Name: | Lumbar interbody with integrated fixation |
| Device Classification: | Class II |
| Regulation Name, | |
| Regulation Number, | |
| Product Code: | Intervertebral fusion device with integrated fixation, lumbar, 888.3080, OVD |
| Device Description: | NEXXT MATRIXX® is a collection of additively manufactured implants. The |
| Stand Alone ALIF System includes additively manufactured interbody and | |
| traditionally machined fixation screw implants. The interbody 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 interbody 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 | |
| interbody incorporates a vertical cavity which can be packed with bone graft | |
| material. Each interbody is preassembled with turn lock mechanisms which | |
| secure the screws to the interbody component. | |
| The NEXXT MATRIXX® Stand Alone ALIF System is a stand-alone anterior | |
| Indications for Use: | lumbar interbody fusion system intended for use as an adjunct to fusion at |
| one or two contiguous levels (L2-S1) in skeletally mature patients for the | |
| treatment of degenerative disc disease (defined as discogenic back pain | |
| with degeneration of the disc confirmed by history and radiographic | |
| studies). These patients may also have up to Grade I spondylolisthesis or | |
| retrolisthesis at the involved levels and should have received at least six | |
| months of nonoperative treatment prior to treatment with the device. The | |
| NEXXT MATRIXX® Stand Alone ALIF System is to be used with autograft | |
| bone graft and/or allogeneic bone graft composed of cancellous and/or | |
| corticocancellous bone. Hyperlordotic interbody devices (>20° lordosis) | |
| must be used with supplemental fixation (e.g. posterior fixation). Each | |
| interbody fusion device having a lordotic angle 20° or less is intended to be | |
| used with the bone screws provided and requires no additional fixation. | |
| Materials: | NEXXT MATRIXX® Stand Alone ALIF System interbody implants are |
| manufactured from Ti-6Al-4V ELI titanium alloy per ASTM F3001. The | |
| fixation screws and turn lock subcomponents are manufactured from Ti- | |
| 6Al-4V ELI titanium alloy per F136. | |
| Primary Predicate: | AXTI™ Titanium Stand-Alone ALIF System (Innovasis, Inc. - K182139) |
| Performance Data: | Mechanical testing of worst case NEXXT MATRIXX® Stand Alone ALIF |
| System devices included subsidence, static and dynamic compression, and | |
| static and dynamic compression shear according to ASTM F2267 and | |
| ASTM F2077. In addition, expulsion and screw pushout properties were | |
| evaluated. | |
| The mechanical test results demonstrate that Stand Alone ALIF System | |
| performance is substantially equivalent to the predicate devices. | |
| Technological | |
| Characteristics: | The NEXXT MATRIXX® Stand Alone ALIF 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 ALIF | |
| System is the same as previously cleared devices. | |
| Conclusion: | The NEXXT MATRIXX® Stand Alone ALIF System possesses the same |
| intended use and technological characteristics as the predicate devices. | |
| Therefore the Stand Alone ALIF System is substantially equivalent for its | |
| intended use. |
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