The Spinal Simplicity Posterior Fusion Plate is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental 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);

· spondylolisthesis;
· trauma (i.e., fracture or dislocation); and/or
• tumor.
The Posterior Fusion Plate is intended for use with bone graft material and is not intended for standalone use. The device may be implanted via a minimally invasive lateral approach (L1-S1) or a minimally invasive posterior approach (T1-S1).

The Spinal Simplicity Minuteman G3 MIS Fusion Plate is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental 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);

· spondylolisthesis;
· trauma (i.e., fracture or dislocation); and/or
• tumor.
The Minuteman G3 MIS Fusion Plate is intended for use with bone graft material and is not intended for standalone use. The device may be implanted via a minimally invasive lateral approach (L1-S1) or a minimally invasive posterior approach (T1-S1).

The Spinal Simplicity HA Minuteman G3 MIS Fusion Plate is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental 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);

· spondylolisthesis;
· trauma (i.e., fracture or dislocation); and/or
• tumor.
The HA Minuteman G3 MIS Fusion Plate is intended for use with bone graft material and is not intended for standalone use. The device may be implanted via a minimally invasive lateral approach (L1-S1) or a mimimally invasive posterior approach (T1-S1).

The Spinal Simplicity HA Minuteman G3-R MIS Fusion Plate is a posterior, nonpedicle supplemental fixation device, intended for use at a single level in the noncervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental 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);
spondylolisthesis;
trauma (i.e., fracture or dislocation); and/or
tumor.
The HA Minuteman G3-R MIS Fusion Plate is intended for use with bone graft material and is not intended for standalone use. The device may be implanted via a minimally invasive lateral approach (L1-S1).

Device Description

The Minuteman devices consist of bilateral Plates and a Body/Post that connects the Plates, identical to the predicate constructs. The Plate components include several spiked grips at the ends of each Plate for attachment to the spinous processes. The Minuteman devices are available in multiple sizes to accommodate varying patient anatomy. The Minuteman devices are made from Ti6Al4V and Ti6Al4V ELI. The HA versions of the Minuteman devices have an additional hydroxyapatite coating on the distal regions of the device.

AI/ML Overview

This document describes the marketing approval for the Spinal Simplicity Minuteman G3 MIS Fusion Plate system. It is a 510(k) submission, meaning the manufacturer is demonstrating that its device is substantially equivalent to legally marketed predicate devices, rather than proving its safety and effectiveness from scratch. Therefore, the information provided focuses on the equivalence to existing devices and updates to indications for use, rather than a detailed study proving novel acceptance criteria for the device itself.

Based on the provided text, here's a summary of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states: "There are no changes to the functional characteristics from the previously cleared versions of each Minuteman device. The only differences are labeling updates. Therefore, no non-clinical performance data has been submitted." and "The only difference is regarding updated Indications for Use."

This indicates that the acceptance criteria for the device's performance are implicitly met by its substantial equivalence to previously cleared devices. Specific numerical performance criteria (e.g., tensile strength, fatigue life) are not detailed in this regulatory summary because the device itself hasn't changed. The acceptance for this 510(k) is based on the updated Indications for Use being supported by existing data and the design being identical to cleared predicates.

The "reported device performance" is essentially that it performs identically to its predicate devices, which have already met their respective acceptance criteria.

2. Sample size used for the test set and the data provenance:

Test set sample size: Not applicable or not explicitly stated in the context of this 510(k) summary for this submission. This submission is for an updated Indications for Use on an already cleared device, where the device itself hasn't changed technologically or functionally.
Data provenance: "Clinical data from a prospective, randomized clinical study of the Minuteman was presented." No country of origin is specified. The study was prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document. The clinical study mentioned would have involved clinical endpoints, but the method for establishing "ground truth" (e.g., through expert diagnosis or objective measures) is not detailed.

4. Adjudication method for the test set:

This information is not provided in the document.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a physical spinal implant, not an AI-powered diagnostic or assistive technology.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The clinical study evaluated "satisfactory clinical outcomes." This implies that outcomes data (e.g., patient-reported outcomes, objective measures of fusion, reduction in pain) were used, likely assessed by clinical experts.

8. The sample size for the training set:

Not applicable. As a physical device, there is no "training set" in the context of machine learning. The clinical study described in section 9 would represent the data used to support the device's indications.

9. How the ground truth for the training set was established:

Not applicable for a training set. For the clinical study that supported the device, the summary states: "The Minuteman was compared to surgical decompression in the treatment of skeletally-mature patients diagnosed with lumbar spinal stenosis with or without accompanying spondylolisthesis. The data showed that the Minuteman provided satisfactory clinical outcomes." This suggests the efficacy was established by comparing clinical outcomes between the Minuteman device and surgical decompression in a prospective, randomized clinical trial. The specific metrics for "satisfactory clinical outcomes" are not elaborated upon in this document but would typically involve patient-reported pain scores, functional assessments, and potentially radiographic evidence of fusion.

Summary

{0}------------------------------------------------

December 15, 2021

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized eagle. The FDA logo is on the right and features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Spinal Simplicity LLC Mr. Adam Rogers Director of Regulatory 6600 College Blvd, Suite 220 Overland Park. Kansas 66211

Re: K212781

Trade/Device Name: Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA Minuteman G3 MIS Fusion Plate, HA Minuteman G3-R MIS Fusion Plate Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal Interlaminal Fixation Orthosis Regulatory Class: Class II Product Code: PEK Dated: November 17, 2021

Received: November 18, 2021

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 (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 located 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.

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

{1}------------------------------------------------

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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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

{2}------------------------------------------------

510(k) Number (if known) K212781

Device Name

Posterior Fusion Plate / HA Posterior Fusion Plate

Indications for Use (Describe)

· 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);

· spondylolisthesis;
· trauma (i.e., fracture or dislocation); and/or

• tumor.

The Posterior Fusion Plate is intended for use with bone graft material and is not intended for standalone use. The device may be implanted via a minimally invasive lateral approach (L1-S1) or a minimally invasive posterior approach (T1-S1).

Type of Use (Select one or both, as applicable)
MA	COLLECTIC OF LIGHT COLLECT PARTIC COLLECT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CONTRACT CASE CONSTITUTION CONSULTITION CONSULTITION CONSULTITION CONSULTITION CONSULTI

| > 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

{3}------------------------------------------------

510(k) Number (if known) K212781

Device Name

Spinal Simplicity Minuteman G3 MIS Fusion Plate

Indications for Use (Describe)

· 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);

· spondylolisthesis;
· trauma (i.e., fracture or dislocation); and/or

• tumor.

The Minuteman G3 MIS Fusion Plate is intended for use with bone graft material and is not intended for standalone use. The device may be implanted via a minimally invasive lateral approach (L1-S1) or a minimally invasive posterior approach (T1-S1).

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.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{4}------------------------------------------------

510(k) Number (if known) K212781

Device Name

Spinal Simplicity HA Minuteman G3 MIS Fusion Plate

Indications for Use (Describe)

· 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);

· spondylolisthesis;
· trauma (i.e., fracture or dislocation); and/or

• tumor.

The HA Minuteman G3 MIS Fusion Plate is intended for use with bone graft material and is not intended for standalone use. The device may be implanted via a minimally invasive lateral approach (L1-S1) or a mimimally invasive posterior approach (T1-S1).

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.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{5}------------------------------------------------

510(k) Number (if known) K212781

Device Name

Spinal Simplicity HA Minuteman G3-R MIS Fusion Plate

Indications for Use (Describe)

The Spinal Simplicity HA Minuteman G3-R MIS Fusion Plate is a posterior, non-pedicle supplemental fixation device, intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental 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);

· spondylolisthesis;
· trauma (i.e., fracture or dislocation); and/or

• tumor.

The HA Minuteman G3-R MIS Fusion Plate is intended for use with bone graft material and is not intended for standalone use. The device may be implanted via a minimally invasive lateral approach (L1-S1).

Type of Use (Select one or both, as applicable)

☑ Research Use (Part 21 CFR 58) (Select One)
☐ For Therapeutic Use (Select One)

|X 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.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

{6}------------------------------------------------

510(k) Summary: Spinal Simplicity's Minuteman MIS Fusion Plate Implant System

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared:

Spinal Simplicity LLC 6600 College Blvd Suite 220 Overland Park, KS 66211 Phone: (913) 451-4414 Facsimile: (913) 888-0075

Contact Person: Adam Rogers

Date Prepared: December 9, 2021

Name of Device:

Minuteman MIS Fusion Plate Implant Family

Minuteman G3 MIS Fusion Plate
HA Minuteman G3 MIS Fusion Plate ●
HA Minuteman G3-R MIS Fusion Plate
Posterior Fusion Plate / HA Posterior Fusion Plate ●

Common / Classification Name:

Spinous Process Plate, 21 CFR 888.3050 - Spinal Interlaminal Fixation Orthosis, Class II Product codes: PEK

Predicate Devices:

Primary Predicate Device:

Spinal Simplicity's Posterior Fusion Plate / HA Posterior Fusion Plate (K200066) ●
Additional Predicate Devices:
Spinal Simplicity's HA Minuteman G3 MIS Fusion Plate (K151741)
Spinal Simplicity's Minuteman G3 MIS Fusion Plate (K140046)
Spinal Simplicity's HA Minuteman G3-R MIS Fusion Plate (K163428)

Device Description:

{7}------------------------------------------------

from Ti6Al4V and Ti6Al4V ELI. The HA versions of the Minuteman devices 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, or material changes have been made to the devices since being granted 510(k) clearance.

Intended Use / Indications for Use:

Spinal Simplicity Posterior Fusion Plate / HA Posterior Fusion Plate: ●
The Spinal Simplicity Posterior Flate is a posterior, non-pedicle supplemental fixation device. intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental 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);
spondylolisthesis; ●
trauma (i.e., fracture or dislocation); and/or
tumor. ●

Spinal Simplicity Minuteman G3 / HA Minuteman G3:
The Spinal Simplicity Minuteman G3 / HA Minuteman G3 MIS Fusion Plate is a posterior. non-pedicle supplemental fixation device. intended for use at a single level in the non-cervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental 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);
spondylolisthesis: ●
trauma (i.e., fracture or dislocation); and/or ●
. tumor.

The Minuteman G3 / HA Minuteman G3 MIS Fusion Plate is intended for use with bone graft material and is not intended for standalone use. The device may be

{8}------------------------------------------------

implanted via a minimally invasive lateral approach (L1-S1) or a minimally invasive posterior approach (T1-S1).

Spinal Simplicity HA Minuteman G3-R ●
The Spinal Simplicity HA Minuteman G3-R MIS Fusion Plate is a posterior, nonpedicle supplemental fixation device, intended for use at a single level in the noncervical spine (T1-S1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental 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);
spondylolisthesis; ●
trauma (i.e., fracture or dislocation); and/or ●
tumor. ●

Technological Characteristics:

There are no changes to the technological characteristics from the previously cleared versions of each Minuteman device. The only differences are labeling updates.

Performance Data:

There are no changes to the functional characteristics from the previously cleared versions of each Minuteman device. The only differences are labeling updates. Therefore, no non-clinical performance data has been submitted.

Clinical Data:

Clinical data from a prospective, randomized clinical study of the Minuteman was presented. The Minuteman was compared to surgical decompression in the treatment of skeletally-mature patients diagnosed with lumbar spinal stenosis with or without accompanying spondylolisthesis. The data showed that the Minuteman provided satisfactory clinical outcomes.

{9}------------------------------------------------

Substantial Equivalence:

The Spinal Simplicity Minuteman family of implants subject to this 510(k) notice are the same as the predicate devices cleared under K140046, K151741, K163428, and K200066. The only difference is regarding updated Indications for Use. The provided clinical data and information from the previous 510(k) applications support the conclusion that the subject devices with updated Indications for Use are substantially equivalent to the previously cleared predicate devices.

Conclusions:

The information submitted by Spinal Simplicity in this premarket notification demonstrates that the Minuteman implants perform as intended and are substantially equivalent to the predicate devices.

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
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.(b)
Classification. Class II.