(12 days)
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.
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.
The provided FDA 510(k) Clearance Letter for the EVOL® ha - Hyper C Cervical Interbody Fusion System does not contain details about acceptance criteria or specific studies proving device performance against such criteria in the way you've described (e.g., related to AI/ML device performance metrics like sensitivity, specificity, MRMC studies, or ground truth establishment).
This document is a marketing clearance for a traditional medical device (an intervertebral body fusion system, which is a physical implant) and not a software-as-a-medical-device (SaMD) or an AI/ML powered device. The "acceptance criteria" and "studies" you're asking about are typically associated with the rigorous validation of diagnostic accuracy or clinical utility for AI/ML systems.
Instead, for this physical medical device, "acceptance criteria" would primarily relate to its mechanical and material performance to ensure it is substantially equivalent to a predicate device and safe/effective for its intended use. The "studies" mentioned are non-clinical (benchtop) tests to demonstrate this.
Here’s a breakdown based on the information provided, adapted to the context of a physical implant:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from predicates and regulations) | Reported Device Performance (Summary from document) |
|---|---|---|
| Material Composition | Conforms to specified medical-grade materials, biocompatibility. | Manufactured from PEEK-OPTIMA® LT1 2HA (Invibio) per ASTM F2026. Imbeds tantalum beads per ASTM F560 (for visualization). Substantially equivalent to predicates in materials. |
| Mechanical Performance | Withstands physiological loads, resists displacement, maintains structural integrity. | Passed ASTM F2077 (Standard Test Method for Axial Compression, Condylar Compression, and Shear Testing of Intervertebral Body Fusion Devices). Passed expulsion testing. The larger sizes (potentially worst-case) demonstrated no compromise to strength or structural integrity. |
| Design Features | Has features for proper placement and function (e.g., bone graft window, anti-expulsion features). | Central window for bone graft. Inferior and superior faces have teeth to resist migration. Various footprint sizes, depths, and lordotic angles. |
| Sterility | Achieves specified Sterility Assurance Level (SAL). | "Sterility Assurance Level (SAL)" is listed as a characteristic compared to predicates, implying compliance. |
| Visualization | Radiographic visibility for placement and follow-up. | Tantalum beads embedded to aid visualization under fluoroscopy. |
| Biocompatibility | No adverse biological reactions. | Manufacturing materials (PEEK, Tantalum) are standard for interbody fusion devices and are generally recognized as biocompatible for this application. Implied by substantial equivalence. |
| Intended Use | Aligns with predicate device's intended use for cervical interbody fusion. | The intended use remains unchanged and uses language from both predicates. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the document. For benchtop mechanical testing (like ASTM F2077 and expulsion testing), sample sizes are typically determined by the specific ASTM standard or internal quality protocols to achieve statistical significance for engineering parameters, but they are generally small (e.g., 5-10 devices per test condition depending on variability).
- Data Provenance: The tests are non-clinical, meaning they are laboratory/benchtop studies. There is no patient data involved (retrospective or prospective) for this type of device validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not Applicable. For a physical interbody fusion device, "ground truth" in the diagnostic AI sense does not apply. The "ground truth" for mechanical testing is established by the engineering specifications and performance standards defined in ASTM or similar bodies. Expert interpretation might be involved in initial design and test protocol development (e.g., biomechanical engineers), but not in establishing a diagnostic "ground truth" for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are used to establish a consensus "ground truth" for diagnostic labels in medical imaging or pathology, often in the context of human reader studies for AI/ML devices. This is not relevant for the mechanical testing of a physical implant.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This type of study (MRMC for AI assistance) is not applicable to a physical intervertebral body fusion system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is
FDA 510(k) Clearance Letter - EVOL® ha Hyper C Cervical Interbody Fusion System
Page 1
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 (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"
Page 2
(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 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 (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-reporting-combination-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 Rule"). 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-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).
Page 3
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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Submission Number (if known): K250605
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, lordosis, 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 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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Page 5
510(k) Summary
Prepared on: 2025-02-28
Contact Details
21 CFR 807.92(a)(1)
| Field | Value |
|---|---|
| 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)
| Field | Value |
|---|---|
| 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 have a footprint (width and depth), and lordotic angle. 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® LT1 2HA (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 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, lordosis, 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 are to be used in patients who have had at least six weeks of non-operative treatment.
Page 1 of 2
Page 6
K250605 Page 2 of 2
Indications for Use Comparison
21 CFR 807.92(a)(5)
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)
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 intended for 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 subject device is 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 lordotic 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 worst case for Cutting Edge Spine for some of the required mechanical 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 System 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 or efficacy 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, design features, 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.
Page 2 of 2
§ 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.