Minuteman® G6 MIS Fusion Plate

K253250 · Spinal Simplicity, LLC · PEK · Dec 1, 2025 · Orthopedic

Device Facts

• Record ID: K253250
• Device Name: Minuteman® G6 MIS Fusion Plate
• Applicant: Spinal Simplicity, LLC
• Product Code: PEK · Orthopedic
• Decision Date: Dec 1, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Spinal Simplicity Minuteman G6 MIS Fusion Plate is a posterior, non-pedicle fusion device, intended for use at a single interspace in the non-cervical spine (L1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving instrumented posterior arthrodesis (i.e., fusion) in the following conditions: • Lumbar spinal stenosis; • Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); and/or • Spondylolisthesis. The Minuteman G6 MIS Fusion Plate is intended for use with bone graft material. The device may be implanted via a lateral transverse approach (L1-S1).

Device Story

Minimally invasive, interspinous-interlaminar fusion device; provides immobilization, stabilization, and fusion of spinal segments. Device features two sets of wings for attachment to spinous processes; core threaded post provides controlled distraction. Implanted via lateral transverse approach under fluoroscopic guidance. Used in non-cervical spine (L1-S1). Intended for use with bone graft material to achieve arthrodesis. Benefits patient by stabilizing spinal segments in cases of stenosis, DDD, or spondylolisthesis.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing (ASTM F1717 static/dynamic compression, static torsion, custom pull-off) and cadaver testing.

Technological Characteristics

Constructed of Ti-6Al-4V ELI titanium alloy (ASTM F136) with hydroxyapatite (HA) coating (ASTM F1185). Interspinous-interlaminar fixation design with two sets of wings and threaded post. Sterile, single-use, implanted via lateral transverse approach.

Indications for Use

Indicated for patients requiring instrumented posterior arthrodesis at a single interspace in the non-cervical spine (L1-S1) for lumbar spinal stenosis, degenerative disc disease, or spondylolisthesis. Intended for use with bone graft material.

Regulatory Classification

Identification

A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.

Predicate Devices

• Minuteman G5 MIS Fusion Plate (K234051)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

December 1, 2025

Spinal Simplicity, LLC
Adam Rogers
SVP, Regulatory & Engineering
6363 College Blvd
Suite 320
Overland Park, Kansas 66211

Re: K253250
Trade/Device Name: Minuteman® G6 MIS Fusion Plate
Regulation Number: 21 CFR 888.3050
Regulation Name: Spinal Interlaminal Fixation Orthosis
Regulatory Class: Class II
Product Code: PEK
Dated: September 26, 2025
Received: September 29, 2025

Dear Adam Rogers:

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.

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

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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" (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-

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K253250 - Adam Rogers
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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).

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. | K253250 | ? |
| Please provide the device trade name(s). | | ? |
| Minuteman® G6 MIS Fusion Plate | | |
| Please provide your Indications for Use below. | | ? |
| The Spinal Simplicity Minuteman G6 MIS Fusion Plate is a posterior, non-pedicle fusion device, intended for use at a single interspace in the non-cervical spine (L1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving instrumented posterior arthrodesis (i.e., fusion) in the following conditions:

• Lumbar spinal stenosis;
• Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); and/or
• Spondylolisthesis.

The Minuteman G6 MIS Fusion Plate is intended for use with bone graft material. The device may be implanted via a lateral transverse approach (L1-S1). | | |
| 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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K253250- Page 1 of 2

| 510(k) #: | 510(k) Summary | Prepared on: 2025-09-26 |
| --- | --- | --- |
| Contact Details | | 21 CFR 807.92(a)(1) |
| Applicant Name | Spinal Simplicity, LLC | |
| Applicant Address | 6363 College Blvd Suite 320 Overland Park KS 66211 United States | |
| Applicant Contact Telephone | 913-451-4414 | |
| Applicant Contact | Mr. Adam Rogers | |
| Applicant Contact Email | [e-mail] | |
| Device Name | | 21 CFR 807.92(a)(2) |
| Device Trade Name | Minuteman® G6 MIS Fusion Plate | |
| Common Name | Spinal interlaminal fixation orthosis | |
| Classification Name | Spinous Process Plate | |
| Regulation Number | 888.3050 | |
| Product Code(s) | PEK | |
| Legally Marketed Predicate Devices | | 21 CFR 807.92(a)(3) |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K234051 | Minuteman G5 MIS Fusion Plate | PEK |
| Device Description Summary | | 21 CFR 807.92(a)(4) |
| The Minuteman G6 MIS Fusion Plate is a minimally invasive, interspinous-interlaminar fusion device intended for the fixation and fusion of the lumbar and sacral spine. The Minuteman G6 MIS Fusion Plate is composed of Ti-6Al-4V ELI titanium alloy per ASTM F136 and is coated with hydroxyapatite (HA) per ASTM F1185. It is designed for attachment to the posterior non-cervical spine at the spinous processes through its two sets of wings and is intended for use with bone graft material placed within the device. The Minuteman G6 MIS Fusion Plate provides immobilization, stabilization, and fusion of the spinal segments. The core threaded post provides controlled distraction, while a wide range of sizes allows for enhanced anatomical fit. The Minuteman G6 MIS Fusion Plate can easily be placed under fluoroscopy through a lateral transverse MIS approach. The Minuteman G6 MIS Fusion Plate is delivered sterile and individually packed. | | |
| Intended Use/Indications for Use | | 21 CFR 807.92(a)(5) |
| The Spinal Simplicity Minuteman G6 MIS Fusion Plate is a posterior, non-pedicle fusion device, intended for use at a single interspace in the non-cervical spine (L1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving instrumented posterior arthrodesis (i.e., fusion) in the following conditions: • Lumbar spinal stenosis; • Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); and/or • Spondylolisthesis. The Minuteman G6 MIS Fusion Plate is intended for use with bone graft material. The device may be implanted via a lateral transverse approach (L1-S1). | | |

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| Indications for Use Comparison 21 CFR 807.92(a)(5) |
| --- |
| The Minuteman G6 MIS Fusion Plate has the same intended use and indications for use as the predicate device. |
| Technological Comparison 21 CFR 807.92(a)(6) |
| The Minuteman G6 MIS Fusion Plate has the same technological characteristics as the predicate device. Non-Clinical performance and cadaver testing demonstrates the ability of the device to be used safely and effectively for the indicated use. The Minuteman G6 MIS Fusion Plate is substantially equivalent to the predicate device. |
| Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b) |
| Non-clinical tests were performed to support substantial equivalence of the Minuteman G6 MIS Fusion Plate. Custom bench and cadaver tests were also performed to support the performance of the device. This testing included: ASTM F1717 Static Compression Testing ASTM F1717 Static Torsion Testing ASTM F1717 Dynamic Compression Testing Custom Pull Off Testing Cadaver Testing Clinical performance testing was not conducted for this submission. Spinal Simplicity concludes that the performance testing provided in this S10(k) application demonstrates that the Minuteman G6 MIS Fusion Plate is capable of performing as intended and is as safe and effective as the legally marketed predicate device. |