Synergy Disc Instruments

K253392 · Synergy Spine Solutions, Inc. · QLQ · Mar 27, 2026 · Orthopedic

Device Facts

• Record ID: K253392
• Device Name: Synergy Disc Instruments
• Applicant: Synergy Spine Solutions, Inc.
• Product Code: QLQ · Orthopedic
• Decision Date: Mar 27, 2026
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.4515
• Device Class: Class 2

Intended Use

The Synergy Disc Instruments are intended for the placement, positioning, and removal of the Synergy Disc.

Device Story

Synergy Disc Instruments are a collection of reusable manual surgical tools; used by surgeons during total disc replacement procedures. Instruments facilitate placement, positioning, and removal of Synergy Disc implants. Device is used in an operating room setting. Surgeons operate instruments to manipulate the implant during the procedure. No automated processing or software involved. Benefits include enabling precise surgical implantation and revision of the Synergy Disc.

Clinical Evidence

Bench testing only. Testing included retainer and pin verification, pin and driver verification, pilot cutter test, modular depth stop test, life and durability test, and usability/cadaver testing.

Technological Characteristics

Manual surgical instruments. Materials: Stainless Steels (Grades 17-4, 18-8, 301, 302, 316, 465) per ASTM A564, ASTM A276, ASTM A666, ASTM F899; polymers (HDPE, PPSU) per ASTM D6712. Reusable. Sterilization method similar to predicate.

Indications for Use

Indicated for the placement, positioning, and removal of the Synergy Disc during surgical implantation or removal procedures.

Regulatory Classification

Identification

Orthopedic manual surgical instrumentation for use with total disc replacement devices are non-powered hand-held devices designed specifically for use with a total disc replacement device and interface with the associated implant for the purpose of insertion, removal, placement, or repositioning, or to cut, rasp, or create a defect specific to the features of the associated implant. This type of device includes instruments specific to the geometry of the implant.

Special Controls

*Classification.* Class II (special controls). The special controls for this device are:(1) Technical specifications regarding geometry of the instruments must be specified and validated to demonstrate that the instruments can safely position, place, or remove the implant. (2) The patient contacting components of the device must be demonstrated to be biocompatible. (3) Performance data must demonstrate that reprocessing of reusable devices that are provided non-sterile, or sterilization of devices provided sterile, is validated. (4) Labeling must include: (i) Identification of implant(s) and instruments which have been validated for use together; and (ii) Validated methods and instructions for reprocessing any reusable parts.

Predicate Devices

• Centinel Spine prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments (K221848)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

March 27, 2026

Synergy Spine Solutions, Inc.
% Veronica Downen
MCRA, LLC
803 7th St. NW
Washington, District of Columbia 20001

Re: K253392
Trade/Device Name: Synergy Disc Instruments
Regulation Number: 21 CFR 888.4515
Regulation Name: Orthopedic Manual Surgical Instrumentation For Use With Total Disc Replacement Devices
Regulatory Class: Class II
Product Code: QLQ
Dated: February 27, 2026
Received: February 27, 2026

Dear Veronica Downen:

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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K253392 - Veronica Downen
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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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).

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 Management System Regulation (QMSR) (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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K253392 - Veronica Downen
Page 3

Sincerely,

MAZIAR SHAH-MOHAMMADI-S

For: Colin O'Neill, M.B.E.
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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FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services [phone]
EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K253392 | |
| Device Name Synergy Disc Instruments | |
| Indications for Use (Describe) The Synergy Disc Instruments are intended for the placement, positioning, and removal of the Synergy Disc. | |
| 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 [e-mail] | |
| "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." | |

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K253392
Page 1 of 2

510(k) Summary

Device Trade Name: Synergy Disc Instruments
Device Common Name: Manual instruments designed for use with total disc replacement devices
Manufacturer: Synergy Spine Solutions Inc.
357 S. McCaslin Blvd, Suite 120
Louisville, CO 80027
Contact: Josh Butters
CEO
Synergy Spine Solutions
357 S. McCaslin Blvd, Suite 120
Louisville, CO 80027
Office: 720-787-9063
Prepared by: MCRA, LLC
803 7th Street, NW, 3rd Floor
Washington, DC 20001
Office: 202.552.5800
Date Prepared: March 21, 2026
Classifications: 21 CFR 888.4515; Orthopedic manual surgical instrumentation for use with total disc replacement devices
Class: II
Product Codes: QLQ
Primary Predicate: Centinel Spine prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments (K221848)

Indications For Use:
The Synergy Disc Instruments are intended for the placement, positioning, and removal of the Synergy Disc.

Device Description:
The Synergy Disc Instruments are a collection of reusable instruments designed for use with the Synergy Disc during the implantation procedure and, if necessary, device removal. Synergy Spine Solutions instruments and implants are not compatible with implants or instruments from other manufacturers unless otherwise specified. The Synergy Disc Instruments are made from

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K253392
Page 2 of 2

various Stainless Steels (Grades 17-4, 18-8, 301, 302, 316, 465) and polymers, including High Density Polyethylene (HDPE) and medical grade Polyphenylsulfone (PPSU), as described in such standards as ASTM A564, ASTM A276, ASTM A666, ASTM F899, and ASTM D6712.

## Predicate Device:

The purpose of this Traditional 510(k) is to demonstrate that the Synergy Disc Instruments are substantially equivalent to predicate devices for the purpose of introducing the system to interstate commerce. It has been determined that the Synergy Disc Instruments are substantially equivalent to the following predicate:

- Primary Predicate: Centinel Spine prodisc C SK, prodisc C Nova, and prodisc C Vivo Instruments (K221848)

Overall, the Synergy Disc Instruments share the following similarities to the predicate product:

- shares the same intended use
- shares the same indications for use
- incorporates similar materials
- has identical sterilization process
- has identical conditions of use

## Performance Testing Summary:

The following bench testing has been conducted on the Synergy Disc Instruments:

- Performance Testing
- Retainer and Pin Verification Test
- Pin and Driver Verification Test
- Pilot Cutter Test
- Modular Depth Stop Test
- Life and Durability Test
- Usability/ Cadaver Testing

## Substantial Equivalence:

The subject devices were demonstrated to be substantially equivalent to the predicates cited with respect to indications, design materials, function, manufacturing, and performance. The non-clinical tests performed by the company demonstrated that the Synergy Disc Instruments are able to perform as intended and are substantially equivalent to the predicate devices.

## Conclusion:

The subject device and the predicate devices have the same intended use, have similar technological characteristics, and are made of similar materials. The subject and predicate devices are packaged in similar materials and are sterilized using similar methods. The data included in this submission demonstrates substantial equivalence to the predicate devices listed above.