SPINAL ELEMENTS CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM

K122771 · Spinal Elements, Inc. · OVE · Jan 10, 2013 · Orthopedic

Device Facts

• Record ID: K122771
• Device Name: SPINAL ELEMENTS CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM
• Applicant: Spinal Elements, Inc.
• Product Code: OVE · Orthopedic
• Decision Date: Jan 10, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Spinal Elements Cervical Intervertebral Body Fusion System is a stand-alone interbody fusion device intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone. These patients may have had a previous nonfusion spinal surgery at the involved spinal level(s). Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with these devices. The implant is designed to accommodate two screws. Two screws should be used to ensure adequate fixation of the implant.

Device Story

Cervical interbody fusion system; box-shaped implant body with graft-packing holes and superior/inferior teeth for migration resistance; includes two fixation screws with titanium ring inserts. Implanted via open, anterior approach by surgeons; packed with autogenous bone. Screws provide fixation to bone to prevent migration. Device materials include titanium alloy (Ti-6Al-4V) or PEEK; screws include nitinol subcomponents. Used in clinical settings for spinal fusion; provides structural support and stabilization to facilitate bone fusion; benefits patients by addressing discogenic pain.

Clinical Evidence

Bench testing only. Mechanical performance evaluated via static/dynamic compression and torsion (ASTM F2077-03) and subsidence testing (ASTM F2267-04). Results indicate performance equivalent to predicate devices.

Technological Characteristics

Implant body: Ti-6Al-4V (ASTM F136/ISO 5832-3) or PEEK (ASTM F2026). Screws: Ti-6Al-4V (ASTM F136/ISO 5832-3) with nitinol (ASTM F2063) subcomponents. Box-shaped geometry with teeth and screw holes with titanium inserts. Mechanical fixation via two screws.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (discogenic back pain confirmed by history/radiography) at one cervical level (C3-C7). Includes patients with prior non-fusion surgery at the level. Requires 6 weeks of prior non-operative treatment. Contraindications: none stated.

Regulatory Classification

Identification

An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.

Special Controls

*Classification.* (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval. (c) *Date premarket approval application (PMA) or notice of product development protocol (PDP) is required.* Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

Predicate Devices

• Spinal Elements Mosaic system (K071833)
• Globus Coalition system (K083389)

Submission Summary (Full Text)

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Spinal Elements, Inc. Premarket Notification - Cervical Intervertebral Body Fusion System

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#### 510(k) Summary Cervical Intervertebral Body Fusion System

#### 510(k) Number K122771

JAN 1 0 2013

#### 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 Bkimball(@spinalelements.com

January 9, 2013 Date Prepared:

Proprietary Name Cervical Intervertebral Body Fusion System Intervertebral Body Fusion Device Common Name Device Classification 21 CFR 888.3080 (Intervertebral Body Fusion Device) Proposed Regulatory Class Class II Device Product Code OVE

#### Purpose of this Special 510(k)

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

#### Device Description

Spinal Elements' Cervical Intervertebral Body Fusion System is composed of an implant body and fixation screws. The implant body is a generally box-shaped device with holes through its body for the placement of graft material. Additionally, it has teeth located on its superior and inferior external surfaces to help keep the device from migrating once placed in its desired location. There are also screw holes located in the implant body. Each screw hole is lined in its internal surface with a titanium ring insert.

Screws pass through screw holes of the implant body and affix to bone to help prevent implant migration. When fully seated, the screw head rests on the titanium insert of the screw hole.

Device implant bodies are made from either titanium alloy (Ti-6A1-4V) conforming to ASTM F 136 or ISO 5832-3 or polyetheretherketone conforming to ASTM F 2026.

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

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Screws are made from Ti-6AI-4V per ASTM F 136 or ISO 5832-3 with certain subcomponents manufactured from nitinol conforming to ASTM F2063.

#### Intended Use of the Device

The Spinal Elements Cervical Intervertebral Body Fusion System is a stand-alone interbody fusion device intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone. These patients may have had a previous nonfusion spinal surgery at the involved spinal level(s).

Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with these devices.

The implant is designed to accommodate two screws. Two screws should be used to ensure adequate fixation of the implant.

#### Performance Data

Non-clinical, mechanical testing was performed to determine the performance profile of the device. Testing included:

- Static Compression testing as per ASTM F 2077-03 A
- > Static Torsion testing as per ASTM F 2077-03
- > Dynamic Compression testing as per ASTM F 2077-03
- > Dynamic Torsion testing as per ASTM F 2077-03
- > Subsidence Testing as per ASTM F 2267-04

All test results indicate the device will perform as intended based on a comparison to devices cleared for similar or identical indications for use.

#### Substantial Equivalence

The device seeking clearance is substantially equivalent to the Spinal Elements Mosaic system cleared under K071833, and the Globus Coalition system cleared under K083389. The indications for use, intended use, surgical technique, materials, and technological characteristics are virtually the same.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the bird symbol.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Letter dated: January 10, 2013

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

Re: K122771

Trade/Device Name: Cervical Intervertebral Body Fusion System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: OVE Dated: December 3, 2012 Received: December 10, 2012

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 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 - Mr. Benjamin A. Kimball

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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

## Mark N. Melkerson

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) K:122771

Device Name: Cervical Intervertebral Body Fusion System

#### Indications for Use:

The Spinal Elements Cervical Intervertebral Body Fusion System is a stand-alone interbody fusion device intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autogenous bone. These patients may have had a previous non-fusion spinal surgery at the involved spinal level(s).

Patients must have undergone a regimen of at least six (6) weeks of non-operative treatment prior to being treated with these devices.

The implant is designed to accommodate two screws. Two screws should be used to ensure adequate fixation of the implant.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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# Ronald P. Jean -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K122771