Cervical Interbody and VBR Fusion System

K252219 · Sync Surgical · ODP · Jan 14, 2026 · Orthopedic

Device Facts

Record IDK252219
Device NameCervical Interbody and VBR Fusion System
ApplicantSync Surgical
Product CodeODP · Orthopedic
Decision DateJan 14, 2026
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 888.3080
Device ClassClass 2
AttributesTherapeutic

Intended Use

The Sync Cervical Interbody Fusion System is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage. The Sync VBR Fusion System is a vertebral body replacement system indicated for use in skeletally mature patients to replace a collapsed, damaged, diseased, or unstable vertebral body due to tumor or trauma (i.e. fracture) or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues. The device is intended for use in the cervical spine (from C3 to C7) and in the thoracolumbar spine (from T1-L5). The device is intended for use with supplemental fixation cleared by the FDA for use in the cervical, thoracic, or lumbar spine and is to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft.

Device Story

System comprises intervertebral body fusion cages and vertebral body replacement (VBR) components; available in various heights/footprints. Used by surgeons in spinal procedures to facilitate fusion or replace damaged vertebral bodies. Inputs include patient anatomy; device provides structural support for bone graft. Used with supplemental fixation. Benefits include spinal stabilization and decompression. No software or algorithm involved.

Clinical Evidence

No clinical data submitted. Substantial equivalence supported by mechanical bench testing per FDA guidance for spinal systems (ASTM F2077, ASTM F2267).

Technological Characteristics

Materials: Titanium alloy (Ti-6Al-4V, ASTM F136) and PEEK (ASTM F2026). Tantalum marker pins (ASTM F560) for visualization. Mechanical testing: static/dynamic axial compression, torsion (ASTM F2077), subsidence (ASTM F2267), and expulsion. Non-active, implantable device.

Indications for Use

Indicated for skeletally mature patients requiring intervertebral body fusion for cervical DDD (C2-T1) with radicular symptoms, or vertebral body replacement (cervical C3-C7; thoracolumbar T1-L5) due to tumor, trauma, or post-corpectomy reconstruction. Requires supplemental fixation and bone graft.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Related Devices

Submission Summary (Full Text)

{0} FDA U.S. FOOD & DRUG ADMINISTRATION January 14, 2026 Sync Surgical % Daniel Johnson Regulatory Engineer DJJ Consulting LLC 10301 Lake Ave Cleveland, Ohio 44102 Re: K252219 Trade/Device Name: Cervical Interbody and VBR Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: ODP, PLR, MQP Dated: December 22, 2025 Received: December 22, 2025 Dear Daniel Johnson: 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 {1} K252219 - Daniel Johnson 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). {2} K252219 - Daniel Johnson 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 {3} 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) K252219 Device Name Cervical Interbody and VBR Fusion System Indications for Use (Describe) The Sync Cervical Interbody Fusion System is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage. The Sync VBR Fusion System is a vertebral body replacement system indicated for use in skeletally mature patients to replace a collapsed, damaged, diseased, or unstable vertebral body due to tumor or trauma (i.e. fracture) or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues. The device is intended for use in the cervical spine (from C3 to C7) and in the thoracolumbar spine (from T1-L5). The device is intended for use with supplemental fixation cleared by the FDA for use in the cervical, thoracic, or lumbar spine and is to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft. 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) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov “An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number.” {4} Page 1 of 2 | 510(k) #: K252219 | 510(k) Summary | Prepared on: 2025-12-22 | | --- | --- | --- | | Contact Details | 21 CFR 807.92(a)(1) | | | Applicant Name | Sync Surgical | | | Applicant Address | 5705 Eastman Drive Plano TX 75093 United States | | | Applicant Contact Telephone | 512-635-8141 | | | Applicant Contact | Mr. Shawn Culbertson | | | Applicant Contact Email | shawnc@arfabricating.com | | | Correspondent Name | DJJ Consulting LLC | | | Correspondent Address | 10301 Lake Ave Cleveland OH 44102 United States | | | Correspondent Contact Telephone | 216-333-2127 | | | Correspondent Contact | Mr. Daniel Johnson | | | Correspondent Contact Email | danieljacobj@gmail.com | | | Device Name | 21 CFR 807.92(a)(2) | | | Device Trade Name | Cervical Interbody and VBR Fusion System | | | Common Name | Intervertebral body fusion device Spinal intervertebral body fixation orthosis | | | Classification Name | Intervertebral Fusion Device With Bone Graft, Cervical Spinal Vertebral Body Replacement Device | | | Regulation Number | 888.3080 and 888.3060 | | | Product Code(s) | ODP, PLR, MQP | | | Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | | | Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | | K1 63494 | Summit Spine Channel Cervical Interbody Fusion System | ODP | | K191778 | Omnia Medical VBR | PLR | | K241494 | Pantheon Pedicle Screw and Iliac Bolt Fixation System | NKB | | Device Description Summary | 21 CFR 807.92(a)(4) | | | The Sync Cervical Interbody Fusion System is an anterior interbody fusion device for use in the cervical spine (C2-T1). The Sync VBR Fusion System is a vertebral body replacement device for use in the cervical and thoracic spine. Interbody and VBR Fusion components are available in a variety of heights and footprints to suit the individual pathology and anatomy of the patient. The device components are made from titanium alloy (Ti-6Al-4V) conforming to ASTM F136 or PEEK conforming to ASTM F2026. The PEEK interbody fusion | | | {5} device components have tantalum marker pins manufactured from tantalum per ASTM F560 for radiographic visualization. K252219 Page 2 of 2 | Intended Use/Indications for Use | 21 CFR 807.92(a)(5) | | --- | --- | | The Sync Cervical Interbody Fusion System is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage. | | | The Sync VBR Fusion System is a vertebral body replacement system indicated for use in skeletally mature patients to replace a collapsed, damaged, diseased, or unstable vertebral body due to tumor or trauma (i.e. fracture) or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues. The device is intended for use in the cervical spine (from C3 to C7) and in the thoracolumbar spine (from T1-L5). The device is intended for use with supplemental fixation cleared by the FDA for use in the cervical, thoracic, or lumbar spine and is to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft. | | | Indications for Use Comparison | 21 CFR 807.92(a)(5) | | The subject device indications are the same as the predicate device indications | | | Technological Comparison | 21 CFR 807.92(a)(6) | | The subject and predicate devices have the same technological characteristics | | | Non-Clinical and/or Clinical Tests Summary & Conclusions | 21 CFR 807.92(b) | | Mechanical performance of the Sync Cervical Interbody and VBR Fusion System was evaluated based on the FDA recommendations in the Spinal Systems Guidance for and product codes ODP, PLR, and MQP. Mechanical testing including static and dynamic axial compression and torsion per ASTM F2077, subsidence per ASTM F2267, and expulsion testing were performed on the worst-case device in the system. | | | There is no clinical testing being submitted with this application. | | | The subject device is substantially equivalent to the predicate devices in mechanical performance. | |
Innolitics
510(k) Summary
Decision Summary
Classification Order
Enter a record ID and click Load to view the document.
100%