Altus Spine Cervical Plate System

K163061 · Altus Partners, LLC · KWQ · Feb 6, 2017 · Orthopedic

Device Facts

• Record ID: K163061
• Device Name: Altus Spine Cervical Plate System
• Applicant: Altus Partners, LLC
• Product Code: KWQ · Orthopedic
• Decision Date: Feb 6, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Altus Spine Cervical Plate System is interior interbody fixation of the cervical spine. The system is indicated for use in temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with degenerative disc 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, deformity (defined as kyphosis, lordosis, or scoliosis), pseudosarthrosis and/or failed previous fusions. The Altus Spine Cervical Plate System can be implanted in the sub-axial cervical spine from the C3 through C7 levels.

Device Story

The Altus Spine Cervical Plate System is an orthopedic implant for anterior cervical spine fixation. It consists of a metal plate secured to vertebral bodies via self-tapping or self-drilling bone screws. The system features graft windows for intraoperative visualization and bone graft placement. It is used by surgeons in an operating room setting to provide temporary stabilization during the fusion process. The device is intended to maintain alignment and support the spine while bone healing occurs, potentially reducing pain and restoring stability in patients with degenerative, traumatic, or structural spinal conditions.

Clinical Evidence

Bench testing only. Static and dynamic compression bending and static torsion testing were performed in accordance with ASTM F1717 to demonstrate mechanical equivalence to predicate devices.

Technological Characteristics

Constructed from Titanium Alloy (ASTM F136). System includes cervical plates of varying lengths and fixed/variable bone screws (self-tapping/self-drilling). Features include graft windows for visualization. Mechanical performance validated via ASTM F1717 testing.

Indications for Use

Indicated for patients with degenerative disc disease, trauma (fractures), tumors, deformity (kyphosis, lordosis, scoliosis), pseudarthrosis, or failed previous fusions requiring temporary anterior stabilization during cervical spine fusion at levels C3-C7.

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

• Cardo Medical Cervical Plate System (K091396)
• Accin Cervical Plate System (K073530)
• Vertebron SCP Cervical Plate System (K040003)

Submission Summary (Full Text)

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

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" arranged 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

February 6, 2017

Altus Partners, LLC Claudia Hill RA/OA Lead 1340 Enterprise Drive West Chester, Pennsylvania 19380

Re: K163061

Trade/Device Name: Altus Spine Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: January 10, 2017 Received: January 11, 2017

Dear Ms. Hill:

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 devicerelated 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.

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

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/ResourcesforYou/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,

Mark N. Melkerson -S

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

Enclosure

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

# Indications for Use

510(k) Number (if known) K163061

#### Device Name Altus Spine Cervical Plate System

#### Indications for Use (Describe)

The Altus Spine Cervical Plate System is interior interbody fixation of the cervical spine. The system is indicated for use in temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with degenerative disc 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, deformity (defined as kyphosis, lordosis, or scoliosis), pseudosarthrosis and/or failed previous fusions. The Altus Spine Cervical Plate System can be implanted in the sub-axial cervical spine from the C3 through C7 levels.

| 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.*

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

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

# 510(k) Summary

| SUBMITTER: | Altus Partners<br>1340 Enterprise Drive<br>West Chester, PA 19380<br>Phone: [phone]<br>Fax: [phone] |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| CONTACT PERSON: | Claudia Hill, MSME, RAC<br>Regulatory Affairs & Quality Assurance<br>[e-mail] |
| DATE PREPARED: | October 3, 2016 |
| COMMON NAME: | Anterior Cervical Plate System |
| PROPRIETARY NAME: | Altus Spine Cervical Plate System |
| PRIMARY PREDICATE DEVICE: | Cardo Medical Cervical Plate System from Cardo Medical Corporation<br>(K091396) |
| ADDITIONAL PREDICATE DEVICES: | Accin Cervical Plate System by Accelerated Innovations, LLC<br>(K073530); Vertebron SCP Cervical Plate System (K040003) |
| CLASSIFICATION NAME: | 21 CFR §888.3060 |
| PRODUCT CODES: | KWQ |
| DEVICE CLASS: | Class II |
| MATERIAL: | The material used is Titanium Alloy that conforms to ASTM F136 |

## DEVICE DESCRIPTION:

The Altus Spine Cervical Plate System is intended for anterior fixation of the cervical spine. The fixation construct consists of a cervical plate that is attached to the vertebral body of the cervical spine with both self-tapping and self-drilling bone screws. The plates are available in a variety of lengths addressing multiple levels of fixation (one to four). The Altus Spine Cervical Plate System includes graft windows on the longitudinal center line for intraoperative visualization and for screw fixation of bone graft. Fixed or variable bone screws are available in two diameters and a variety of lengths, with the options of either self-tapping or self-drilling threads.

## INDICATIONS FOR USE:

The Altus Spine Cervical Plate System is intended for anterior interbody fixation of the cervical spine. The system is indicated for use in temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with degenerative disc 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, deformity (defined as kyphosis, lordosis, or scoliosis), pseudosarthrosis and/or failed previous fusions. The Altus Spine Cervical Plate System can be implanted in the sub-axial cervical spine from the C3 through C7 levels.

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

#### SUMMARY OF TECHNOLOGICAL CHARACTERISTICS:

The technological characteristics of the Altus Spine Cervical plate system is equivalent to the predicate device, except for the locking mechanism. The locking mechanism is provided to ensure that the bone screws remain in place.

#### SUMMARY OF NON-CLINICAL TESTS SUBMITTED:

Static and dynamic compression bending and static torsion testing in accordance with ASTM F1717 was performed and demonstrated that the Altus Spine Cervical Plate System is substantially equivalent to the predicate devices.

# SUBSTANTIAL EQUIVALENCE CONCLUSION:

The Altus Spine Cervical Plate System is substantially equivalent to the predicate devices in terms of intended use, material used, and performance. The device has a similar design, dimensions and instrumentation to the predicate devices.