SAPPHIRE ANTERIOR CERVICAL PLATE SYSTEM

K101848 · Spinal Elements, Inc. · KWQ · Oct 14, 2010 · Orthopedic

Device Facts

• Record ID: K101848
• Device Name: SAPPHIRE ANTERIOR CERVICAL PLATE SYSTEM
• Applicant: Spinal Elements, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Oct 14, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Sapphire Anterior Cervical Plate System is intended for anterior cervical fixation ( C2 - C7) in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (including fracture or dislocation), spinal stenosis, deformities or curvatures (kyphosis, lordosis or scoliosis), tumor, pseudoarthrosis, and failed previous fusion.

Device Story

Sapphire Anterior Cervical Plate System; spinal fixation hardware for anterior cervical spine (C2-C7). System includes titanium alloy plates and screws; plates feature radial/lordotic curvature and windows for graft/endplate visualization. Screws available in fixed or variable angle designs with internal locking mechanisms. Used by surgeons in clinical settings to stabilize spine during fusion procedures. Provides mechanical support to facilitate bone fusion; benefits patients by addressing instability from trauma, degeneration, or deformity.

Clinical Evidence

Bench testing only. Mechanical testing conducted in accordance with ASTM F 1717, including dynamic compression, static compression, static tension, and static torsion.

Technological Characteristics

Materials: Titanium alloy (Ti-6Al-4V) per ASTM F 136/ISO 5832-3; nitinol subcomponents per ASTM F 2063. Design: Plates with radial/lordotic curvature and visualization windows; fixed and variable angle screws with internal locking mechanisms. Mechanical testing per ASTM F 1717.

Indications for Use

Indicated for anterior cervical fixation (C2-C7) in skeletally mature patients as an adjunct to fusion for degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, deformities (kyphosis, lordosis, scoliosis), tumor, pseudoarthrosis, and failed previous fusion.

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

• Atomic® Anterior Cervical Plate System (K060491)
• Synthes Anterior Cervical Vertebrae Plate (K926453)
• Amendia, LLC. Diamond Anterior Cervical Plate System (K100265)
• Medtronic, Orion Anterior Cervical Plate System (K042499)

Submission Summary (Full Text)

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Spinal Elements, Inc. Premarket Notification -Sapphire™ Anterior Cervical Plate System

pg 1 of 2

OCT 1 4 2010

# 510(k) Summary Sapphire™ Anterior Cervical Plate System

510(k) Number K101848

Manufacturer Identification · Submitted by:

Spinal Elements, Inc. 2744 Loker Ave. W., Suite 100 Carlsbad, CA 92010 760-607-0121

Contact Information:

Benjamin A. Kimball Regulatory Affairs Manager Spinal Elements, Inc. 2744 Loker Ave. W., Suite 100 Carlsbad, CA 92010 760-607-1816 [e-mail]

Date Prepared:

June 29, 2010

Device Indentification Proprietary Name Common Name Device Classification

Proposed Regulatory Class Device Product Code

Sapphire™ Anterior Cervical Plate System Anterior Cervical Plate System 21 CFR 888.3060 (Appliance, Fixation Spinal Intervertebral Body) Class II KWQ

#### Purpose of this 510(k)

This 510(k) seeks clearance for a new spinal system.

#### Device Description

The Sapphire Anterior Cervical Plate System is comprised of plates and screws that are used for attachment to the anterior cervical spine. Both plates and screws are available in a variety of sizes to suit the individual pathology and anatomic condition of the patient. Plates are pre-shaped with radial and lordotic curvature and have large windows for graff and end plate visualization. Plates range in length to accommodate one to four levels of fusion.

Screws are available in both fixed and variable angle designs. Fixed angle screws have a predetermined trajectory relative to the plate. Variable angle screws provide freedom in traiectory of the screws into the vertebral body. All screws are equipped with an internal locking mechanism.

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K101848

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Plates and screws are manufactured from titanium alloy (Ti-6A1-4V) conforming to ASTM F 136 or ISO 5832-3, with certain subcomponents manufactured from nitinol conforming to ASTM F 2063.

## Intended Use of the Device

The Sapphire Anterior Cervical Plate System is intended for anterior cervical fixation ( C2 - C7) in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (including fracture or dislocation), spinal stenosis, deformities or curvatures (kyphosis, lordosis or scoliosis), tumor, pseudoarthrosis, and failed previous

fusion.

# Substantial Equivalence

The Sapphire™ Anterior Cervical Plate System was shown to be substantially equivalent previously cleared devices in indications for use, design, function, and materials used.

- > Atomic® Anterior Cervical Plate System (K060491).
- > Synthes Anterior Cervical Vertebrae Plate (K926453).
- > Amendia, LLC. Diamond Anterior Cervical Plate System (K100265).
- > Medtronic, Orion Anterior Cervical Plate System (K042499).

### Performance Data

Mechanical testing was conducted in accordance with ASTM F 1717, and included:

- A Dynamic compression
- A Static compression
- A Static tension and
- > Static torsion.

Mechanical testing indicates that the Sapphire™ Anterior Cervical Plate System is capable of performing in accordance with its intended use and is substantially equivalent to predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.

#### Public Health Service

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

OCT 1 4 2010

Spinal Elements, Inc. % Mr. Benjamin A. Kimball Regulatory Affairs Manager 2744 Loker Avenue West, Suite 100 Carlsbad, California 92010

Re: K101848

Trade/Device Name: Sapphire™ Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWO Dated: August 18, 2010 Received: September 20, 2010

Dear Mr. Kimball:

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

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Page 2 - Mr. Benjamin A. Kimball

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely yours,

For
Mark N. Melkerson

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

Enclosure

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# Indications for Use

**510(k) Number (if known):**

510(k) Number (if known):

Device Name: Sapphire™ Anterior Cervical Plate System

#### Indications for Use:

The Sapphire Anterior Cervical Plate System is intended for anterior cervical fixation (C2 - C7) in skeletally mature patients as an adjunct to fusion for the following indications: degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (including fracture or dislocation), spinal stenosis, deformities or curvatures (kyphosis, lordosis or scoliosis), tumor, pseudoarthrosis, and failed previous fusion.

Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

A

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

KIDI898 510(k) Number_

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