NAKOMA ACP

K141993 · Alliance Partners, LLC · KWQ · Nov 6, 2014 · Orthopedic

Device Facts

• Record ID: K141993
• Device Name: NAKOMA ACP
• Applicant: Alliance Partners, LLC
• Product Code: KWQ · Orthopedic
• Decision Date: Nov 6, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Nakoma ACP System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The Nakoma ACP System is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusion in patients with the following indications: Degenerative Disk Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) Trauma (including fractures) Tumors Deformities or curvatures (including kyphosis, lordosis or scoliosis) Pseudoarthrosis Failed previous fusions Spondylolisthesis Spinal Stenosis

Device Story

Nakoma ACP System is an anterior cervical plating system used in spinal fusion surgery to provide structural stability. System comprises titanium alloy plates and screws; includes surgical instrumentation for implantation. Plates feature visualization windows and locking clips for screw retention; screws are self-tapping/self-drilling with variable angle placement (15° medial/lateral, 10° cephalad/caudal). Used by surgeons in clinical settings to provide temporary stabilization of the anterior spine during fusion development. Device provides mechanical support to adjacent vertebrae; aids in achieving spinal fusion. Benefits include stabilization of the cervical spine in patients with degenerative, traumatic, or structural spinal conditions.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via non-clinical bench testing in accordance with ASTM F1717 standards.

Technological Characteristics

Materials: Titanium alloy per ASTM F136. Components: Plates (Levels 1-5) with visualization windows and locking clips; self-tapping/self-drilling screws. Mechanical: Variable angle screw placement (15° medial/lateral, 10° cephalad/caudal). Testing: ASTM F1717 (static compression, static torsion, dynamic compression).

Indications for Use

Indicated for patients requiring anterior cervical spine fusion (C2-T1) for degenerative disc disease, trauma (fractures), tumors, deformities (kyphosis, lordosis, scoliosis), pseudoarthrosis, failed previous fusions, spondylolisthesis, or spinal stenosis.

Regulatory Classification

Identification

A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.

Predicate Devices

• Custom Spine-REGENT (K091134)
• Aesculap-QUINTEX (K100243)

Submission Summary (Full Text)

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

November 6, 2014

Alliance Partners, LLC % Ms. Kellen Hills Quality & Regulatory Consultant Orchid Design 4600 East Shelby Drive Memphis, Tennessee 38118

Re: K141993

Trade/Device Name: Nakoma ACP System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: August 8, 2014 Received: August 11, 2014

Dear Ms. Hills:

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

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Page 2 - Ms. Kellen Hills

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.

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" (21CFR 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 vours.

# 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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# Indications for Use

510(k) Number (if known) K141993

Device Name Nakoma ACP system

Indications for Use (Describe)

| spine fusion in patents with the following indications: |
|---------------------------------------------------------|
|---------------------------------------------------------|

| • Degenerative Disk Disease | (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies) |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| • Trauma | (including fractures) |
| • Tumors | |
| • Deformities or curvatures | (including kyphosis, lordosis or scoliosis) |
| • Pseudoarthrosis | |
| • Failed previous fusions | |
| • Spondylolisthesis | |
| • Spinal Stenosis | |

The Nakoma ACP System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The Nakoma ACP System is indicated for temporary stabilization of the auting the development of cervical

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)

# PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

## FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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| (a)(1) | Submitted By: | Alliance Partners, LLC |
|--------|------------------------------------|---------------------------------------------|
| | | 14206 Northbrook Dr. |
| | | San Antonio, TX 78232 |
| | Phone: | 210-314-2525 |
| | Fax: | 210-314-2524 |
| | Date: | November 6, 2014 |
| | Contact Persons | |
| | Primary: | Kellen Hills (Orchid Design Consulting) |
| | Secondary: | Frank Morris (Alliance Partners, LLC) |
| (a)(2) | Proprietary Name: | Nakoma ACP |
| | Common Name: | Anterior Cervical Plate |
| | Classification Name and Reference: | 21CFR 888.3060 - Spinal intervertebral body |
| | | fixation orthosis |
| | Product Code: | KWQ |
| (a)(3) | Predicate Devices: | |

- redicate Devices Custom Spine-REGENT (K091134) Primary: Secondary: Aesculap-QUINTEX (K100243)
### Device Description: (a)(4)

The Nakoma Anterior Cervical Plating (ACP) system is used for spinal fusion surgery to provide support and structural stability. The system consists of a variety of plates and screws, all of which are manufactured from titanium alloy per ASTM F136. Instrumentation necessary for proper implantation is also included.

The plates are available in a range of lengths in Levels 1-5 and feature windows to aid in visualization and locking clips to assist in screw retention. The screws are available in multiple lengths and diameters, feature self-tapping and self-drilling designs and are able to be placed on-axis and at various angles (15° medial/lateral, 10° cephalad/caudal).

The purpose of this submission is to gain initial marketing authorization in the United States.

### (a)(5) Indications for Use:

The Nakoma ACP System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The Nakoma ACP System is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusion in patents with the following indications:

- Degenerative Disk Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
- Trauma (including fractures)
- Tumors
- Deformities or curvatures (including kyphosis, lordosis or scoliosis)
- · Pseudoarthrosis
- Failed previous fusions
- Spondylolisthesis

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- Spinal Stenosis
- (a)(6) Comparison of Technological Characteristics:
- The fundamental scientific technology, materials of construction and mechanism of operation is the same between the subject Nakoma ACP and predicate Regent ACP device. Both are intervertebral fusion devices, designed to provide support and stabilization in order to achieve fusion between adjacent vertebrae. Both subject and predicate devices are made from titanium alloy and incorporate retention clips and multiple screw options. Both subject and predicate devices offer plates and screws in comparable size ranges. Both devices utilize instrumentation common to spinal fusion surgery.

Additionally, Aesculap's QUINTEX system was used as a dimensional predicate for the Level 5 plates of the subject Nakoma ACP system.

- (b)(1) Non-clinical testing:
Testing in accordance with ASTM F1717 (i.e., static compression, static torsion, dynamic compression) was conducted and the subject devices were found to perform equivalently to the predicates.

## (b)(2) Clinical testing:

Clinical testing was not required to demonstrate substantial equivalence in this premarket notification.

### (b)(3) Conclusions:

Based on the information provided in this premarket notification and the details specified in FDA guidance "Spinal System 510(k)s", we believe that the subject Nakoma ACP system is as safe, as effective, and performs as well as or better than the predicate devices.