(55 days)
Not Found
No
The summary describes a physical implantable device (interbody cage and anchors) and mentions modifications to it. There is no mention of software, algorithms, or data processing that would suggest the use of AI/ML. The performance studies are bench-top usability tests, not algorithmic performance evaluations.
Yes
The device is an anterior cervical interbody fusion system intended to treat cervical disc disease, which involves addressing a medical condition and facilitating fusion for therapeutic purposes.
No
This device is an interbody fusion system, an implantable medical device used to facilitate spinal fusion, not to diagnose a condition.
No
The device description explicitly states it is comprised of an interbody cage and two fixation anchors made from titanium alloy, which are physical hardware components.
Based on the provided text, 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, specifically addressing cervical disc disease. This is a therapeutic intervention, not a diagnostic test performed on samples from the body.
- Device Description: The device is described as an interbody cage and fixation anchors made from titanium alloy. This is a physical implant, not a reagent, instrument, or system used to examine specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information based on in vitro testing.
The device is a surgical implant used to treat a medical condition, which falls outside the definition of an In Vitro Diagnostic device.
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 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.
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 device is offered in a variety of sizes to accommodate patient anatomy.
The purpose of this Traditional510(k) submission is to gain clearance for modifications made to the subject device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
cervical disc disease (DDD) at one level from 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
The subject changes to the Stable-C Interbody System do not introduce a new worst case, as confirmed by bench top usability testing of the device and instrumentation in a simulated implantation. Additional performance testing is not required to establish substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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 for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the agency's name on the right. The symbol on the left is a stylized representation of the Department of Health & Human Services seal. To the right of the seal is the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
July 17, 2024
Nexus Spine, LLC % Christine Scifert Partner MRC Global 9085 East Mineral Circle Suite 110 Centennial, Colorado 80112
Re: K241467
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: May 20, 2024 Received: May 23, 2024
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 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
2
Indications for Use
Submission Number (if known)
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 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.
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
510(k) Summary
Stable-C Interbody System July 15, 2024
| 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 Contact: | Jared Crocker
Vice President of Quality and Regulatory Affairs
Nexus Spine, LLC
Phone: (801) 702-8592
jared.crocker@nexusspine.com |
| Trade Name: | Stable-C Interbody System |
| 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 – K231763 |
| Additional Predicates: | Nexus Spine, LLC Stable-C Interbody System – K232530
Nexus Spine, LLC Tranquil-C Interbody System - K240416 |
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 device is offered in a variety of sizes to accommodate patient anatomy.
The purpose of this Traditional510(k) submission is to gain clearance for modifications made to the subject device.
4
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:
Additional Predicate:
- Nexus Spine, LLC, Tranquil-C Interbody System – K240416
The subject components are identical in indications to the primary predicate Stable-C Interbody System (K232530). Device sizing, geometry, and technological characteristics are similar to the predicate Stable-C (K232530) and Tranquil C devices (K240416). Materials, manufacturing, sterilization, and packaging are identical to those of the primary predicate, Stable-C (K232530). Thus, it can be concluded that the subject does not raise new questions about safety and effectiveness.
Performance Testing:
The subject changes to the Stable-C Interbody System do not introduce a new worst case, as confirmed by bench top usability testing of the device and instrumentation in a simulated implantation. Additional performance testing is not required to establish substantial equivalence.
Conclusion:
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.