(12 days)
Not Found
No
The summary describes a physical implant device for spinal fusion and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML. The device description focuses on materials, design features, and sizes.
Yes
This device is an interbody fusion system intended for permanent implantation to provide fusion of the spine, which is a therapeutic intervention.
No
The device is described as an interbody fusion system designed for surgical implantation to facilitate fusion, not for diagnosing medical conditions.
No
The device description clearly states it is an implant manufactured from PEEK-OPTIMA® LT120 HA with tantalum beads, indicating it is a physical hardware device, not software only.
No, 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, tissue) to provide information about a person's health. They are used outside the body.
- Device Description and Intended Use: The EVOL® ha - Hyper C Cervical Interbody Fusion System is an implantable device designed to be surgically placed inside the body to facilitate the fusion of vertebrae in the cervical spine. It is a structural implant, not a diagnostic test.
- Lack of Diagnostic Function: The device's function is mechanical support and to promote bone fusion. It does not analyze biological samples or provide diagnostic information about a patient's condition.
- Input Imaging Modality: While fluoroscopy is used with the device to aid in visualization during placement, the device itself is not performing the imaging or providing a diagnosis based on the imaging.
Therefore, based on the provided information, the EVOL® ha - Hyper C Cervical Interbody Fusion System is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The EVOL® ha - Hyper C Cervical Interbody Fusion System is intended for intervertebral body fusion of the spine in skeletally mature patients. The EVOL® ha - Hyper C Cervical Interbody Fusion System is indicated for use for anterior cervical interbody fusion in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, or scollosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies at up to two contiguous levels from C2 - T1.
The EVOL® ha – Hyper C Cervical Interbody Fusion System is intended to be used with supplemental fixation. The EVOL® ha - Hyper C Cervical Interbody Fusion System is intended for use with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion. The cervical devices are to be used in patients who have had at least six weeks of non-operative treatment.
Product codes
ODP
Device Description
The EVOL® ha – Hyper C Cervical Interbody Fusion System is designed for use as a cervical interbody fusion device and consists of various sizes to accommodate individual patient anatomy. The sizes vary by footprint (width and lordotic and lordotic ande. All sizes have a central window for bone graft. The inferior and superior faces have teeth to resist migration when placed in between the vertebral bodies. Each spacer has tantalum beads, per ASTM F560, imbedded in the device to aid visualization under fluoroscopy. The implants are manufactured from PEEK-OPTIMA® LT120 HA (Invibio) per ASTM F2026.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopy
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
Additional testing was performed to determine that a change to the product offering (sizes) will not impact the safety of this implant. The testing performed included ASTM F2077 and expulsion testing. A summary of the test data is included.
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.
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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, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 12, 2025
Cutting Edge Spine, LLC Kyle Kuntz Manager R&D 6012 Waxhaw Hwy Mineral Springs, North Carolina 28108
Re: K250605
Trade/Device Name: EVOL® ha - Hyper C Cervical Interbody Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP Dated: February 28, 2025 Received: February 28, 2025
Dear Kyle Kuntz:
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 (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"
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(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).
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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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).
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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
Submission Number (if known)
Device Name
EVOL® ha - Hyper C Cervical Interbody Fusion System
Indications for Use (Describe)
The EVOL® ha - Hyper C Cervical Interbody Fusion System is intended for intervertebral body fusion of the spine in skeletally mature patients. The EVOL® ha - Hyper C Cervical Interbody Fusion System is indicated for use for anterior cervical interbody fusion in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, or scollosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies at up to two contiguous levels from C2 - T1.
The EVOL® ha – Hyper C Cervical Interbody Fusion System is intended to be used with supplemental fixation. The EVOL® ha - Hyper C Cervical Interbody Fusion System is intended for use with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion. The cervical devices are to be used in patients who have had at least 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) #: | 510(k) Summary | Prepared on: 2025-02-28 |
|---|---|---|
| Contact Details | 21 CFR 807.92(a)(1) | |
| Applicant Name | Cutting Edge Spine, LLC | |
| Applicant Address | 6012 Waxhaw Hwy Mineral Springs NC 28108 United States | |
| Applicant Contact Telephone | 704-243-0982x2 | |
| Applicant Contact | Mr. Kyle Kuntz | |
| Applicant Contact Email | k.kuntz@cuttingedgespine.com | |
| Device Name | 21 CFR 807.92(a)(2) | |
| Device Trade Name | EVOL® ha - Hyper C Cervical Interbody Fusion System | |
| Common Name | Intervertebral body fusion device | |
| Classification Name | Intervertebral Fusion Device With Bone Graft, Cervical | |
| Regulation Number | 888.3080 | |
| Product Code(s) | ODP | |
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K180674 | EVOL® ha - C Cervical Interbody Fusion System | ODP |
| K182284 | Tyber Medical PT Interbody Spacer | ODP |
| Device Description Summary | 21 CFR 807.92(a)(4) |
The EVOL® ha – Hyper C Cervical Interbody Fusion System is designed for use as a cervical interbody fusion device and consists of various sizes to accommodate individual patient anatomy. The sizes vary by footprint (width and lordotic and lordotic ande. All sizes have a central window for bone graft. The inferior and superior faces have teeth to resist migration when placed in between the vertebral bodies. Each spacer has tantalum beads, per ASTM F560, imbedded in the device to aid visualization under fluoroscopy. The implants are manufactured from PEEK-OPTIMA® LT120 HA (Invibio) per ASTM F2026.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
The EVOL® ha – Hyper C Cervical Interbody Fusion System is intervertebral body fusion of the spine in skeletally mature patients. The EVOL® ha – Hyper C Cervical Interbody Fusion System is indicated for use for anterior cervical interbody fusion in patients with cervical disc disease, instability, trauma includined as kyphosis, lordosis, ordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies at up to two contiguous levels from C2 - T1.
The EVOL® ha – Hyper C Cervical Interbody Fusion System is intended to be used with supplemental fixation. The EVOL® ha – Hyper C Cervical Interbody Fusion System is intended for use with autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft to facilitate fusion. The cervical devices who have had at least six weeks of non-operative treatment.
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Indications for Use Comparison
While the intended use remains unchanged, the Indications for Use has been reworded to use language from both predicates.
Technological Comparison
21 CFR 807.92(a)(6)
FR 807.92(a)(5)
The subject device is substantially equivalent to the predicates EVOL® ha – C Cervical Interbody Fusion System (K180674) and Tyber Medical PT Interbody Spacer (K182284). The subject device is intervertebral body fusion of the spine in skeletally mature patients.
Cutting Edge Spine, LLC, has demonstrated that, per FDA's regulation of medical devices 888.3040, the substantially equivalent to the predicate devices based on a comparison of the following characteristics:
- FDA product code
- Indications for use
- Surgical Approach
- Anatomical Region
- Implant Materials
- Product Dimensions
- Mechanical Performance
- · Available by prescription only
- · Made for single use
- · Sterility Assurance Level (SAL)
- Technology
The EVOL® ha – Hyper C Cervical Interbody Fusion System and the predicate devices share similarities in intended use, technology, materials, operating principles, design, device features, and performance. These combined predicate characteristics include being manufactured from PEEK per ASTM F2026 with tantalum markers per ASTM F560, being offered in various footprint sizes and heights, having central windows for bone graft, teeth to resist motion and having various lordodic angles.
The differences in technological characteristics between the EVOL® ha – Hyper C Cervical Interbody Fusion System and the predicate devices are the sizes offered. The subject EVOL® ha – Hyper C Cervical Interbody Fusion System offers sizes that are potentially a new worst case for Cutting Edge Spine for some of the required testing when compared to the predicate EVOL® ha – C Cervical Interbody Fusion System (K180674). These differences are implemented without limiting strength or structural integrity.
The scientific methods used are acceptable and can satisfactorily evaluate the difference in technological characteristics which do not raise additional questions about safety and effectiveness compared to the predicate devices. Therefore, it can be concluded that the EVOL® ha – Hyper C Cervical Interbody Fusion is both safe and effective and demonstrates substantial equivalence to the predicate.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Additional testing was performed to determine that a change to the product offering (sizes) will not impact the safety of this implant. The testing performed included ASTM F2077 and expulsion testing. A summary of the test data is included.
Based upon a comparison of technological characteristics, intended use, and mechanical performance, EVOL® ha – Hyper C Cervical Interbody Fusion System does not raise any new concerns of safety or efficacy. The data presented in this submission demonstrates that the devices listed above are substantially equivalent to the predicate devices.