Resolve Anterior Cervical Plate System

K251436 · Pioneer Surgical Technology, Inc. · KWQ · Jul 11, 2025 · Orthopedic

Device Facts

• Record ID: K251436
• Device Name: Resolve Anterior Cervical Plate System
• Applicant: Pioneer Surgical Technology, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Jul 11, 2025
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Resolve Anterior Cervical Plate System is intended for anterior cervical fixation of the cervical spine (C2-C7) as an adjunct to fusion in skeletally mature patients. Specific indications include: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

Device Story

Resolve Anterior Cervical Plate (ACP) System provides anterior cervical fixation for spinal fusion. System comprises non-sterile, single-use titanium alloy (Ti-6Al-4V) plates and screws; includes integrated active locking mechanism; offers various plate lengths; accommodates constrained and variable screws. Used in surgical settings by orthopedic or neurosurgeons to stabilize cervical spine segments. Reusable instruments facilitate implantation and explantation. Device provides mechanical stabilization to support bone fusion; benefits patient by restoring spinal alignment and stability in presence of degenerative, traumatic, or neoplastic conditions.

Clinical Evidence

Bench testing only. Mechanical testing performed per ASTM F1717 (static compression bending, static torsion, dynamic compression bending). MR safety analysis and testing performed per ASTM F2052, ASTM F2213, and ASTM F2182. Results met or exceeded acceptance criteria in the FDA guidance 'Spinal Plating Systems – Performance Criteria for Safety and Performance Based Pathway.'

Technological Characteristics

Materials: Titanium alloy (Ti-6Al-4V). Components: Plates with integrated active locking mechanism, constrained/variable screws. Testing standards: ASTM F1717 (mechanical), ASTM F2052, ASTM F2213, ASTM F2182 (MR safety). Sterilization: Non-sterile (plates/screws single-use, instruments reusable).

Indications for Use

Indicated for anterior cervical fixation (C2-C7) as an adjunct to fusion in skeletally mature patients with degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, deformities, tumor, pseudoarthrosis, or failed previous fusion.

Regulatory Classification

Identification

A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.

Predicate Devices

• CervAlign Anterior Cervical Plate System (K211408)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

July 11, 2025

Pioneer Surgical Technology, Inc
Jaclyn Holli
Manager, Regulatory Affairs
375 River Park Circle
Marquette, MI 49855

Re: K251436
Trade/Device Name: Resolve Anterior Cervical Plate System
Regulation Number: 21 CFR 888.3060
Regulation Name: Spinal Intervertebral Body Fixation Orthosis
Regulatory Class: Class II
Product Code: KWQ
Dated: May 8, 2025
Received: May 8, 2025

Dear Jaclyn Holli:

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"

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K251436 - Jaclyn Holli
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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 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 ([e-mail]) or phone [phone] or 301-796-7100).

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K251436 - Jaclyn Holli
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Sincerely,

MAZIAR SHAH-MOHAMMADI -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

Enclosure

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| Indications for Use | | |
| --- | --- | --- |
| Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K251436 | ? |
| Please provide the device trade name(s). | | ? |
| Resolve Anterior Cervical Plate System | | |
| Please provide your Indications for Use below. | | ? |
| The Resolve Anterior Cervical Plate System is intended for anterior cervical fixation of the cervical spine (C2-C7) as an adjunct to fusion in skeletally mature patients. Specific indications include: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion. | | |
| Please select the types of uses (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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K251436- Page 1 of 2

| 510(k) #: | 510(k) Summary | Prepared on: 2025-07-09 |
| --- | --- | --- |
| Contact Details | | 21 CFR 807.92(a)(1) |
| Applicant Name | Pioneer Surgical Technology, Inc | |
| Applicant Address | 375 River Park Circle Marquette MI 49855 United States | |
| Applicant Contact Telephone | 906-225-5617 | |
| Applicant Contact | Ms. Jaclyn Holli | |
| Applicant Contact Email | [e-mail] | |
| Device Name | | 21 CFR 807.92(a)(2) |
| Device Trade Name | Resolve Anterior Cervical Plate System | |
| Common Name | Spinal intervertebral body fixation orthosis | |
| Classification Name | Appliance, Fixation, Spinal Intervertebral Body | |
| Regulation Number | 888.3060 | |
| Product Code(s) | KWQ | |
| Legally Marketed Predicate Devices | | 21 CFR 807.92(a)(3) |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K211408 | CervAlign Anterior Cervical Plate System | KWQ |
| Device Description Summary | | 21 CFR 807.92(a)(4) |
| The Resolve Anterior Cervical Plate (ACP) System is intended for anterior cervical fixation of the cervical spine (C2-C7) as an adjunct to fusion in skeletally mature patients. The system consists of non-sterile, single use plates and screws that are manufactured from titanium alloy (Ti-6Al-4V). The plates have an integrated active locking mechanism, are offered in various lengths, and accommodate constrained and variable screws. The system includes non-sterile, reusable instruments designed to facilitate proper implantation/explantation of the plates and screws. | | |
| Intended Use/Indications for Use | | 21 CFR 807.92(a)(5) |
| The Resolve Anterior Cervical Plate System is intended for anterior cervical fixation of the cervical spine (C2-C7) as an adjunct to fusion in skeletally mature patients. Specific indications include: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion. | | |
| Indications for Use Comparison | | 21 CFR 807.92(a)(5) |
| With the exception of the addition of target population, the Resolve Anterior Cervical Plate System indications are equivalent to the primary predicate indications. | | |
| Technological Comparison | | 21 CFR 807.92(a)(6) |
| This submission utilizes the Safety and Performance Based Pathway to demonstrate substantial equivalence through performance criteria identified within FDA guidance document "Spinal Plating Systems – Performance Criteria for Safety and Performance Based Pathway." Per the guidance, a primary predicate was still identified. The Resolve Anterior Cervical Plate System is substantially equivalent | | |

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K251436- Page 2 of 2

to the primary predicate technological characteristics. The Resolve Anterior Cervical Plate System was tested and compared to the acceptance criteria identified within the FDA guidance document "Spinal Plating Systems – Performance Criteria for Safety and Performance Based Pathway."

**Non-Clinical and/or Clinical Tests Summary & Conclusions** 21 CFR 807.92(b)

The following mechanical tests were performed on the subject device: static compression bending per ASTM F1717, static torsion testing per ASTM F1717, and dynamic compression bending per ASTM F1717. MR Safety analysis and testing was conducted per ASTM F2052, ASTM F2213, and ASTM F2182 to support MR Conditional Labeling.

Static compression bending, static torsion, and dynamic compression bending testing meet or exceed the acceptance criteria stated in the "Spinal Plating Systems - Performance Criteria for Safety and Performance Based Pathway" guidance document. The test results concluded that the Resolve Anterior Cervical Plate System's worst-case configuration is as safe, as effective, and performs as well as the previously cleared systems that were aggregated to inform the FDA guidance document. In addition, the MR Safety analysis and testing supports the MR Conditional labeling.