HA Minuteman G3 MIS Fusion Plate

K151741 · Spinal Simplicity, LLC · PEK · Aug 20, 2015 · Orthopedic

Device Facts

• Record ID: K151741
• Device Name: HA Minuteman G3 MIS Fusion Plate
• Applicant: Spinal Simplicity, LLC
• Product Code: PEK · Orthopedic
• Decision Date: Aug 20, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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: - degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radio-graphic 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 stand-alone use. The device may be implanted via a minimally invasive posterior approach (T1-S1) or a minimally invasive lateral approach (L1-S1).

Device Story

Posterior, non-pedicle supplemental fixation device; consists of bilateral plates and a body/post connector. Plates feature spikes for spinous process attachment. Implanted via minimally invasive posterior (T1-S1) or lateral (L1-S1) approach by surgeons. Device provides supplemental stability to facilitate fusion when used with bone graft material. Hydroxyapatite coating on distal plate regions promotes integration. Available in multiple sizes to accommodate patient anatomy.

Clinical Evidence

Bench testing only. Characterization of hydroxyapatite powder and coating included particle size, Ca/P ratio, elemental analysis, solubility, dissolution, XRD (ASTM F2024), FTIR, porosity, thickness (SEM), static shear strength (ASTM F1160), and static tensile strength (ASTM F1147). Mechanical strength compared to predicate via ASTM F1717.

Technological Characteristics

Materials: Ti6Al4V (ASTM F1472) and Ti6Al4V ELI (ASTM F136). Coating: Hydroxyapatite (ASTM F1185). Design: Bilateral plates with spikes and central body/post. Mechanical testing: ASTM F1717. Coating testing: ASTM F1160, F1147, F2024.

Indications for Use

Indicated for patients requiring supplemental spinal fusion at a single level (T1-S1) for degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), or tumor. Not for standalone use; must be 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

• Spinal Simplicity's Spinous Process Fusion Plate (K140046)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 20, 2015

Spinal Simplicity, LLC % Ms. Janice M. Hogan Hogans Lovells US, LLP 1835 Market Street, 29th Floor Philadelphia, Pennsylvania 19103

Re: K151741

Trade/Device Name: 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: June 26, 2015 Received: June 26, 2015

Dear Ms. Hogan:

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. 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 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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Janice M. Hogan

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### 510(k) Number (if known)

K151741

Device Name

#### HA Minuteman G3 MIS Fusion Plate

Indications for Use (Describe)

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/atto spinous processes for the purpose of achieving supplemental fusion in the following conditions:

- degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radio-graphic 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 posterior approach (T1-S1) or a minimally invasive lateral approach (L1-S1).

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

区Prescription Use (Part 21 CFR 801 Subpart D)

[ ] Over-The-Counter Use (21 CFR 801 Subpart C)

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# Spinal Simplicity's HA Minuteman G3 MIS Fusion Plate

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

Spinal Simplicity LLC 10995 Quivira Road Overland Park, KS 66210 Phone: [phone] Facsimile: [phone]

Contact Person: Julie McKee, J.D.

Date Prepared: August 18, 2015

#### Name of Device

HA Minuteman G3 MIS Fusion Plate

## Common / Classification Name

Spinous Process Plate, 21 CFR 888.3050, Class II Product codes: PEK

#### Predicate Device

Spinal Simplicity's Spinous Process Fusion Plate (K140046)

## Intended Use / Indications for Use

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:

- degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radio-graphic 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 stand-alone use. The device may be implanted via a minimally invasive posterior approach (T1-S1) or a minimally invasive lateral approach (L1-S1).

#### Device Description

The HA Minuteman G3 MIS Fusion Plate consists of bilateral Plates and a Body/Post that connects the Plates, identical to the predicate construct. The Plate components include several spikes at the ends of each Plate for attachment to the spinous processes. The HA

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Minuteman G3 device is available in multiple sizes to accommodate varying patient anatomy. The HA Minuteman G3 is made from Ti6Al4V (per ASTM F1472) and Ti6Al4V ELI (per ASTM F136) and has a hydroxyapatite coating (per ASTM F1185) at the distal regions of the plate.

# Performance Data

The HA powder was characterized to determine its particle size. Ca/P ratio, elemental analysis, solubility, dissolution products and rates, XRD pattern (per ASTM F2024), and FTIR spectra. The HA coating was characterized to determine its porosity, thickness (via SEM), Ca/P ratio, elemental analysis, static shear strength (per ASTM F1160), static tensile strength (per ASTM 1147), solubility, dissolution products and rates, XRD pattern (per ASTM F2024), and FTIR spectra.

In all instances, the subject device functioned as intended and the results observed were as expected. Further, engineering rationales and modified performance testing per ASTM F1717 demonstrated that the HA Minuteman G3 presents substantially equivalent mechanical strength compared to the predicate device.

# Substantial Equivalence

The Spinal Simplicity HA Minuteman G3 MIS Fusion Plate is as safe and effective as the identified predicate device. The Spinal Simplicity HA Minuteman G3 has the same intended use and indications for use, and similar technological characteristics and principles of operation as its predicate device. The subject device differs from the predicate in the addition of a hydroxyapatite coating at the distal regions of the plate, which does not raise any new issues of safety or effectiveness. Performance data demonstrate that the HA Minuteman G3 is substantially equivalent to the predicate device.

## Conclusions

Therefore, the information submitted by Spinal Simplicity in this premarket notification demonstrates that the HA Minuteman G3 MIS Fusion Plate performs as intended and is substantially equivalent to the predicate device.