Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3 MIS Fusion Plate

K233527 · Spinal Simplicity, LLC · PEK · Nov 29, 2023 · Orthopedic

Device Facts

• Record ID: K233527
• Device Name: Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3 MIS Fusion Plate
• Applicant: Spinal Simplicity, LLC
• Product Code: PEK · Orthopedic
• Decision Date: Nov 29, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Minuteman G5 MIS Fusion Plate is a posterior, non-pedicle fusion device, intended for use at a single interspace in the non-cervical spine (T1-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 G5 MIS Fusion Plate is intended for use with bone graft material. The device may be implanted via a lateral transverse approach (L1-S1) or a posterior approach (T1-S1). The Minuteman G1 (Posterior Fusion Plate/HA Posterior Fusion Plate) is a posterior, non-pedicle fusion device, intended for use at a single interspace in the non-cervical spine (T1-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 G1 (Posterior Fusion Plate/HA Posterior Fusion Plate) is intended for use with bone graft material. The device may be implanted via a lateral transverse approach (L1-S1) or a posterior approach (T1-S1). The HA Minuteman G3-R MIS Fusion Plate is a posterior, non-pedicle fusion device, intended for use at a single interspace in the non-cervical spine (T1-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 HA Minuteman G3-R MIS Fusion Plate is intended for use with bone graft material. The device may be implanted via a lateral transverse approach (L1-S1). The Minuteman G3/HA Minuteman G3 MIS Fusion Plate is a posterior, non-pedicle fusion device, intended for use at a single interspace in the non-cervical spine (T1-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 G3/HA Minuteman G3 MIS Fusion Plate is intended for use with bone graft material. The device may be implanted via a lateral transverse approach (L1-S1) or a posterior approach (T1-S1).

Device Story

Minuteman MIS Fusion Plate Implants are posterior, non-pedicle spinal fixation devices; consist of bilateral plates and a body/post with gripping features for spinous process attachment. Available in multiple sizes; manufactured from Ti6A4V and Ti6A4V ELI; HA versions include hydroxyapatite coating on distal regions. Implanted via lateral transverse or posterior approach to achieve instrumented posterior arthrodesis. Used in clinical settings by surgeons to stabilize the spine in patients with lumbar spinal stenosis, degenerative disc disease, or spondylolisthesis. Device facilitates fusion when used with bone graft material.

Clinical Evidence

No clinical or non-clinical testing was performed for this submission; substantial equivalence is based on identical technological characteristics to the predicate device.

Technological Characteristics

Materials: Ti6A4V and Ti6A4V ELI; HA versions include hydroxyapatite coating. Design: Bilateral plates with body/post and spinous process gripping features. Principle: Posterior non-pedicle spinal fixation/arthrodesis. Form factor: Multiple sizes for patient anatomy.

Indications for Use

Indicated for patients requiring instrumented posterior arthrodesis at a single interspace in the non-cervical spine (T1-S1) for lumbar spinal stenosis, degenerative disc disease, or spondylolisthesis. Used 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 MIS Fusion Plate Implants (K221023)

Submission Summary (Full Text)

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November 29, 2023

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Spinal Simplicity LLC Mr. Adam Rogers Vice President of Regulatory and Engineering 6363 College Blvd Ste 320 Overland Park, Kansas 66211

#### Re: K233527

Trade/Device Name: Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3 MIS Fusion Plate Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal Interlaminal Fixation Orthosis Regulatory Class: Class II Product Code: PEK Dated: November 1, 2023 Received: November 1, 2023

Dear Mr. 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.

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"

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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 OS 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 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-reportingcombination-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.

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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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.

Colin O'neill -S

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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### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K233527

Device Name

Minuteman G5 MIS Fusion Plate;

Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate);

HA Minuteman G3-R MIS Fusion Plate;

Minuteman G3/HA Minuteman G3 MIS Fusion Plate

Indications for Use (Describe)

The Minuteman G5 MIS Fusion Plate is a posterior, non-pedicle fusion device, intended for use at a single interspace in the non-cervical spine (T1-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 G5 MIS Fusion Plate is intended for use with bone graft material. The device may be implanted via a lateral transverse approach (L1-S1) or a posterior approach (T1-S1).

The Minuteman G1 (Posterior Fusion Plate/HA Posterior Fusion Plate) is a posterior, non-pedicle fusion device, intended for use at a single interspace in the non-cervical spine (T1-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 G1 (Posterior Fusion Plate/HA Posterior Fusion Plate) is intended for use with bone graft material. The device may be implanted via a lateral transverse approach (L1-S1) or a posterior approach (T1-S1).

The HA Minuteman G3-R MIS Fusion Plate is a posterior, non-pedicle fusion device, intended for use at a single interspace in the non-cervical spine (T1-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.

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The HA Minuteman G3-R MIS Fusion Plate is intended for use with bone graft material. The device may be implanted via a lateral transverse approach (L1-S1).

The Minuteman G3/HA Minuteman G3 MIS Fusion Plate is a posterior, non-pedicle fusion device, intended for use at a single interspace in the non-cervical spine (T1-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 G3/HA Minuteman G3 MIS Fusion Plate is intended for use with bone graft material. The device may be implanted via a lateral transverse approach (L1-S1) or a posterior approach (T1-S1).

Type of Use (Select one or both, as applicable

iption Use (Part 21 CFR 801 Subpart D)

unter Use (21 CFR 801 Subpart C)

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K233527 - Page 1 of 2

| 510(k) Summary | | | Prepared on: | 2023-11-28 |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--------------|---------------------|
| <b>Contact Details</b> | | | | 21 CFR 807.92(a)(1) |
| Applicant Name | Spinal Simplicity LLC | | | |
| Applicant Address | 6363 College Blvd Ste 320 Overland Park KS 66211 United States | | | |
| Applicant Contact Telephone | 913-451-4414 | | | |
| Applicant Contact | Mr. Adam Rogers | | | |
| Applicant Contact Email | [e-mail] | | | |
| <b>Device Name</b> | | | | 21 CFR 807.92(a)(2) |
| Device Trade Name | Minuteman G5 MIS Fusion Plate;<br>Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate);<br>HA Minuteman G3-R MIS Fusion Plate;<br>Minuteman G3/HA Minuteman G3 MIS Fusion Plate | | | |
| Common Name | Spinous Process Plate | | | |
| Classification Name | Spinous Process Plate | | | |
| Regulation Number | 888.3050 | | | |
| Product Code | PEK | | | |
| <b>Legally Marketed Predicate Devices</b> | | | | 21 CFR 807.92(a)(3) |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | | | Product Code |
| K221023 | Minuteman MIS Fusion Plate Implants | | | PEK |
| <b>Device Description Summary</b> | | | | 21 CFR 807.92(a)(4) |

## Device Description Summary

The Minuteman MIS Fusion Plate Implants consist of bilateral Plates and a Body/Post that connects the Plate components include several gripping features for attachment of the spinous processes. The Minuteman MIS Fusion Plate Implants are available in multiple sizes to accommodate varying patient anatomy. The Minuteman MIS Fusion Plate Implants are made from Ti6A4V and Ti6A4V ELI. The HA versions of the Minuteman MS Fusion Plate Inplants have an additional hydroxyapatite coating on the distal regions of the device.

The purpose of this submission is to update the Indications for Use. No technological, engineering, performance, material or packaging changes have been made to the devices.

# Intended Use/Indications for Use

21 CFR 807.92(a)(5)

The Minuteman G5 MIS Fusion Plate is a posterior, non-pedicle fusion device, intended for use at a single interspace in the non-cervical spine (T1-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 with degeneration of the disc confirmed by history and radiographic studies); and/or

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• spondylolisthesis.

The Minuteman G5 MIS Fusion Plate is intended for use with bone graft material. The device may be implanted via a lateral transverse approach (L1-S1) or a posterior approach (T1-S1).

The Minuteman G1 (Posterior Fusion Plate) is a posterior, non-pedicle fusion device, intended for use at a single interspace in the non-cervical spine (T1-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 G1 (Posterior Fusion Plate) is intended for use with bone graft material. The device may be implanted via a lateral transverse approach (L1-S1) or a posterior approach (T1-S1).

The HA Minuteman G3-R MIS Fusion Plate is a posterior, non-pedicle fusion device, intended for use at a single interspace in the noncervical spine (T1-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 HA Minuteman G3-R MIS Fusion Plate is intended for use with bone graft may be implanted via a lateral transverse approach (L1-S1).

The Minuteman G3/HA Minuteman G3 MIS Fusion Plate is a posterior, non-pedicle fusion device, intended for use at a single interspace in the non-cervical spine (T1-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 with degeneration of the disc confirmed by history and radiographic studies); and/or

• spondylolisthesis.

The Minuteman G3/HA Minuteman G3 MIS Fusion Plate is intended for use with bone graft material. The device may be implanted via a lateral transverse approach (L1-S1) or a posterior approach (T1-S1).

# Indications for Use Comparison

The purpose of this submission is to modify the Indications to the Indications to the Indications for Use statement do not constitute a new intended use of the modifications to the Indications for Use statement do not affect the safety and effectiveness of the Minuteman MIS Fusion Plate Implants. The Minuteman MIS Fusion Plate Implants with the updated Indications for Use are substantially equivalent to the previously cleared predicate devices.

## Technological Comparison

The Minuteman MIS Fusion Plate Implants have the same technological characteristics (same design, packaging, principles of operations) as the cleared predicate devices.

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

Non-Clinical and/or Clinical Tests were not performed as part of this submission. The Minuteman MIS Fusion Plate Implants with the updated Indications for Use are substantially equivalent to the previously cleared predicate devices.

## 21 CFR 807.92(a)(5)