(29 days)
Not Found
No
The summary describes a passive interbody fusion device and its modifications, with no mention of AI or ML capabilities.
Yes
The device is intended for anterior cervical interbody fusion to address conditions like cervical disc degeneration and spinal instability, which are therapeutic medical conditions.
No
The device description clearly states it is an "Interbody System," specifically a "cervical interbody fusion system," which are implants used in surgery to facilitate fusion, not to diagnose a condition. Its intended use is the "anterior cervical interbody fusion" and is used to "facilitate fusion" with bone graft.
No
The device description explicitly states that the implants are manufactured from titanium alloy and are offered in various physical dimensions, indicating a hardware component. The purpose of the 510(k) is to clear modifications to existing cervical implants, which are physical devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description and Intended Use: The Tranquil-C™ Interbody System is a surgical implant intended for use in anterior cervical interbody fusion. It is a physical device implanted into the body to stabilize the spine and facilitate bone fusion.
- Lack of Biological Sample Testing: The description and intended use do not mention any testing of biological samples from the patient. The device's function is mechanical and biological (promoting fusion), not diagnostic based on analyzing bodily fluids or tissues.
The mentions of imaging modalities (radiographs, CT, MRI) are for confirming the patient's condition and guiding the surgical procedure, not for the device itself to perform a diagnostic test.
N/A
Intended Use / Indications for Use
The Tranquil-C™ Interbody System is intended for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at multiple contiguous levels from C2 – T1. The Tranquil-C™ Interbody System is also to be used with supplemental fixation systems that have been cleared for use in the cervical spine. The Tranquil-C™ Interbody System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
Product codes (comma separated list FDA assigned to the subject device)
ODP
Device Description
The Tranquil-C™ Interbody System is a cervical interbody fusion system. Implants are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F3001. The implants are offered in various angles, widths, heights, and lengths to meet patient anatomy for the cervical spine. Implants are provided non-sterile or sterile via gamma irradiation. Instruments are provided clean and non-sterile for steam sterilization at the user's facility.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical spine (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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Engineering analysis has determined that the subject changes do not create a new worst case condition. Therefore, previously conducted testing remains applicable an no additional performance testing is required.
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.
K181483, K170297, K222833, K232530
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.
0
March 12, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Nexus Spine, LLC Christine Scifert MRC Global 9085 East Mineral Circle, Suite 110 Centennial. Colorado 80112
Re: K240416
Trade/Device Name: Tranquil-C Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: February 7, 2024 Received: February 12, 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 QS 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 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,
Katherine D. Kavlock -S
for
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
510(k) Number (if known) K240416
Device Name Tranquil-C Interbody System
Indications for Use (Describe)
The Tranquil-C™ Interbody System is intended for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical spinal instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at multiple contiguous levels from C2 – T1. The Tranquil-CTM Interbody System is also to be used with supplemental fixation systems that have been cleared for use in the cervical spine. The Tranquil-C™ Interbody System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X 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
Tranquil-C Interbody System February 23, 2024
| Company: | Nexus Spine, LLC
2825 East Cottonwood Parkway Suite 330
Salt Lake City, UT 84121 |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary/Secondary Contact: | Christine Scifert - Partner
MRC Global
9085 E. Mineral Cir., Suite 110
Centennial, CO 80112
Phone: (901) 831-8053
Email: christine.scifert@AskMRCGlobal.com
Jen McBride - Regulatory Consultant
(901) 481-5902
Email: jen.mcbride@askmcrglobal.com |
| Company Contact: | Jared Crocker
Vice President of Quality and Regulatory Affairs
Nexus Spine, LLC
Phone: (801) 702-8592
jared.crocker@nexusspine.com |
| Trade Name: | Tranquil-C Interbody System |
| Common Name: | Intervertebral Fusion Device With Bone Graft, Cervical |
| Classification: | Class II |
| Regulation: | 21 CFR 888.3080 (Intervertebral Fusion Device) |
| Panel: | Orthopedic |
| Product Code: | ODP |
| Primary Predicate: | Nexus Spine, LLC Tranquil Interbody System – K181483 |
Device Description:
The Tranquil-C™ Interbody System is a cervical interbody fusion system. Implants are manufactured from titanium alloy (Ti-6Al-4V ELI) per ASTM F3001. The implants are offered in various angles, widths, heights, and lengths to meet patient anatomy for the cervical spine. Implants are provided non-sterile or
4
sterile via gamma irradiation. Instruments are provided clean and non-sterile for steam sterilization at the user's facility.
The purpose of this special 510(k) is to gain clearance for modifications to existing cervical implants and the size range offered.
Indications for Use:
The Tranquil-C™ Interbody System is intended for use for anterior cervical interbody fusion in skeletally mature patients with cervical disc degeneration and/or cervical instability, as confirmed by imaging studies (radiographs, CT, MRI), that results in radiculopathy, and/or pain at multiple contiguous levels from C2 – T1. The Tranquil-C™ Interbody System is also to be used with supplemental fixation systems that have been cleared for use in the cervical spine. The Tranquil-C™ Interbody System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion.
Substantial Equivalence:
The subject Nexus Spine Tranquil-C™ Interbody System is substantially equivalent to the following predicate devices:
Primary Predicate:
- Nexus Spine, LLC, Tranquil™ Interbody System - K181483
Additional Predicates:
- . Nexus Spine, LLC, Tranquil Interbody System – K170297
- . Spinal Elements, Ventana™ C - K222833
- Nexus Spine, LLC – Stable L and Stable C Interbody System – K232530
There are insignificant differences between the subject Tranquil-C™ Interbody System and the predicate Tranquil-C devices (K181483; K170297). Materials and indications of the subject device are identical to those of the predicate devices. There are slight geometry differences between the subject and predicate devices but the extended size range of the subject device falls within the size range of the previously cleared devices. Thus, it can be concluded that the subject does not raise new questions about safety and effectiveness.
Performance Testing:
Engineering analysis has determined that the subject changes do not create a new worst case condition. Therefore, previously conducted testing remains applicable an no additional performance testing is required.
Conclusion:
The subject device is determined to be substantially equivalent to the predicate devices.