(66 days)
Not Found
No
The document describes a physical implantable device (interbody cage and anchors) and its intended use for spinal fusion. There is no mention of software, algorithms, or data processing that would indicate the presence of AI/ML. The performance studies are bench and cadaveric testing, not related to AI/ML model validation.
Yes
The device is an anterior cervical interbody fusion system used to facilitate fusion in patients with cervical degenerative disc disease, which is a therapeutic intervention.
No
Explanation: The device is an anterior cervical interbody fusion system, which is an implant used for treatment (fusion) rather than diagnosis.
No
The device description clearly states the device is comprised of physical components (interbody cage and fixation anchors) made from titanium alloy. It is a hardware implant.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description: The provided text describes a physical implantable device (an interbody cage and fixation anchors) used in surgery to fuse vertebrae in the cervical spine.
- Intended Use: The intended use is to treat cervical degenerative disc disease by providing structural support and facilitating bone fusion. This is a surgical intervention, not a diagnostic test performed on a sample.
The device is a surgical implant used for treatment, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The Nexus Spine Stable-C Interbody System is an anterior cervical interbody fusion system indicated for use in sketally mature patients with cervical disease (DDD) at one level from C2-T1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Stable-C Interbody System is a stand alone system intended to be used with the bone anchors provided. The system is intended to be used with autogenous or allogenic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion. The system is to be used in patients who have had six weeks of non-operative treatment.
Product codes
OVE
Device Description
The Stable-C Interbody System is an anterior cervical interbody device comprised of an interbody cage (lordotic angles of 0, °6°, and 12°) made from titanium alloy (Ti-6Al-4V) per ASTM F3001 and two fixation anchors made from titanium alloy (Ti-6-Al-4V ELI) per ASTM F136. The integrated fixation anchors may not provide adequate stability for all situations. The Surgeon should consider the appropriate fixation required for each patient and determine if additional supplemental fixation may be needed. When used without the supplied fixation, the Stable-C is intended for use with supplemental fixation (e.g., anterior plate, posterior pedicle screws). The device is offered in a variety of sizes to accommodate patient anatomy. The devices and instruments are provided clean and non-sterile for steam sterilization at the user's facility.
The subject system seeks to gain clearance for updated indications for use and design changes to the previously cleared device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
cervical (C2-T1)
Indicated Patient Age Range
skeletally mature patients
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Confirmatory bench performance testing was performed on the subject Stable -C interbody devices dynamic axial compression and dynamic axial compression shear per ASTM F2077-18. Additional cadaveric testing was conducted on the subject IBDs. Testing has confirmed that the proposed design changes and change in indications do not raise new issues of safety and effectiveness and therefore, the subject device is substantially equivalent to the previously cleared device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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.
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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.
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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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 21, 2023
Nexus Spine, LLC % Christine Scifert Partner MRC Global 9085 E. Mineral Cir., Suite 110 Centennial, Colorado 80112
Re: K231763
Trade/Device Name: Stable-C Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE Dated: June 15, 2023 Received: June 16, 2023
Dear Christine Scifert:
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 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.
Brent Showalter -S
Brent 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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Indications for Use
510(k) Number (if known) K231763
Device Name Stable-C Interbody System
Indications for Use (Describe)
The Nexus Spine Stable-C Interbody System is an anterior cervical interbody fusion system indicated for use in sketally mature patients with cervical disease (DDD) at one level from C2-T1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Stable-C Interbody System is a stand alone system intended to be used with the bone anchors provided. The system is intended to be used with autogenous or allogenic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion. The system is to be used in patients who have had six weeks of non-operative treatment.
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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510(k) Summary
Stable-C Interbody System August 7, 2023
Company: Nexus Spine, LLC 2825 East Cottonwood Parkway Suite 330 Salt Lake City, UT 84121
- Primary Contact: Christine Scifert - Partner MRC Global 9085 E. Mineral Cir., Suite 110 Centennial, CO 80112 Phone: (901) 831-8053 Email: christine.scifert@AskMRCGlobal.com
- Company/Secondary Jared Crocker Contact: Vice President of Quality and Regulatory Affairs Nexus Spine, LLC Phone: (801) 702-8592 jared.crocker@nexusspine.com
- Stable-C Interbody System Trade Name: Common Name: Intervertebral Fusion Device With Integrated Fixation, Cervical
- Classification: Class II
- Regulation: 21 CFR 888.3080 (Intervertebral Fusion Device With Integrated Fixation, Cervical)
- Panel: Orthopedic Product Code: OVE Primary Predicate: Nexus Spine, LLC Stable-C Interbody System – K181621
- Stable-C Interbody System Trade Name: Common Name: Intervertebral Fusion Device With Integrated Fixation, Cervical
Device Description:
The Stable-C Interbody System is an anterior cervical interbody device comprised of an interbody cage (lordotic angles of 0, °6°, and 12°) made from titanium alloy (Ti-6Al-4V) per ASTM F3001 and two fixation anchors made from titanium alloy (Ti-6-Al-4V ELI) per ASTM F136. The integrated fixation anchors may not provide adequate stability for all situations. The Surgeon should consider the appropriate fixation required for each patient and determine if additional supplemental fixation may be needed. When used without the supplied fixation, the Stable-C is intended for use with supplemental fixation (e.g., anterior
4
plate, posterior pedicle screws). The device is offered in a variety of sizes to accommodate patient anatomy. The devices and instruments are provided clean and non-sterile for steam sterilization at the user's facility.
The subject system seeks to gain clearance for updated indications for use and design changes to the previously cleared device.
Indications for Use:
The Nexus Spine Stable-C Interbody System is an anterior cervical interbody fusion system indicated for use in skeletally mature patients with cervical disc disease (DDD) at one level from C2-T1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Stable-C Interbody System is a stand alone system intended to be used with the bone anchors provided. The system is intended to be used with autogenous or allogenic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion. The system is to be used in patients who have had six weeks of non-operative treatment.
Substantial Equivalence:
The subject Nexus Spine Stable-C Interbody System is substantially equivalent to the following predicate devices:
Primary Predicate:
- Nexus Spine, LLC, Stable-C Interbody System K181621 ●
Secondary Predicate:
- Aesculap ArcadiusXP C Spinal System - K153629
- . Genesys Spine AIS-C Cervical Stand-Alone System - K181295
There are insignificant differences between the subject Stable-C Interbody System and the primary predicate (K181621). The Indications for Use for the subject device have been expanded to specify use of the integrated anchors, similar to the predicate Genesys Spine AIS-C Stand Alone System (K181295). The Materials of the subject device are identical to those of the primary predicate. There are slight geometry differences between the subject and predicate devices but testing and cadaveric validation have shown that the subject Stable-C Interbody devices perform equivalent to the predicate devices. Thus, it can be concluded that the subject does not raise new questions about safety and effectiveness.
Performance Testing:
Confirmatory bench performance testing was performed on the subject Stable -C interbody devices dynamic axial compression and dynamic axial compression shear per ASTM F2077-18. Additional cadaveric testing was conducted on the subject IBDs. Testing has confirmed that the proposed design changes and change in indications do not raise new issues of safety and effectiveness and therefore, the subject device is substantially equivalent to the previously cleared device.
Conclusion:
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Based on the performance analysis and the comparison to the predicate devices, the subject device is determined to be substantially equivalent to the predicate devices.