SPINESMITH CIMPLICITY SPINAL SYSTEM

K080971 · Spine Smith Partners L.P. · MQP · Jul 2, 2008 · Orthopedic

Device Facts

• Record ID: K080971
• Device Name: SPINESMITH CIMPLICITY SPINAL SYSTEM
• Applicant: Spine Smith Partners L.P.
• Product Code: MQP · Orthopedic
• Decision Date: Jul 2, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cimplicity System is indicated for use to replace a vertebral body that has been resected or excised (i.e. partial or total vertebrectomy) due to tumor or trauma/fracture. The Cimplicity device is intended for use in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation. These devices are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. These devices are intended to be used with autograft or allograft bone. When used as an intervertebral body fusion device, the Cimplicity System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-T1 disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. Cimplicity implants are to be used with autogenous bone graft and implanted via an open, anterior approach. Patients should have at least six weeks of non-operative treatment prior to treatment with a Cimplicity interbody fusion device.

Device Story

Cimplicity Spinal System is a rectangular, hollow implant available in parallel or lordotic configurations; features superior/inferior surface teeth for stability. Used in thoracolumbar spine for vertebral body replacement or cervical spine for interbody fusion. Implanted by surgeons via open, anterior approach; requires supplemental internal fixation. Hollow design accommodates autograft or allograft bone to facilitate fusion. Restores biomechanical integrity of spinal column. Benefits patients by stabilizing spine following resection/excision due to tumor/trauma or treating symptomatic cervical disc disease.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Rectangular, hollow implant; parallel or lordotic configurations; superior/inferior surface teeth for fixation. Materials accommodate autograft/allograft bone. Mechanical testing performed to verify performance.

Indications for Use

Indicated for skeletally mature patients requiring vertebral body replacement (T1-L5) due to tumor or trauma/fracture, or anterior cervical interbody fusion (C2-C3 to C7-T1) for cervical disc disease (intractable radiculopathy/myelopathy). Requires six weeks of prior non-operative treatment for cervical indications.

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

• SpineSmith Cimplicity Spinal System (K073320)
• LDR Spine MC+ (K043479)
• Spinal Elements, Inc. Crystal (K073351)

Submission Summary (Full Text)

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K080971 (pg. 1 of 2)

JUL - 2 2008

# SpineSmith Cimplicity Spinal System

## 510(k) Summary of Safety and Effectiveness

| SUBMITTED BY | SpineSmith Partners, LP<br>8140 N. Mopac, Bldg II, Suite 120<br>Austin, TX 78759 |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| ESTABLISHMENT<br>REGISTRATION NUMBER | 3006404071 |
| CONTACT PERSON | Robert Jones<br>Vice President, Research and Development<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| SUBMISSION PREPARED BY | Lisa Peterson<br>Kaedon Consulting, LLC<br>Phone: [phone] |
| DATE PREPARED | April 2, 2008 |
| CLASSIFICATION | MQP 888.3060- Spinal Intervertebral Body Fixation<br>Orthosis<br>ODP 888.3080 - Intervertebral fusion device with bone graft,<br>cervical |
| COMMON NAME | Spinal Vertebral Body Replacement System (MQP)<br>Intervertebral body fusion device (ODP) |
| PROPRIETARY NAME | SpineSmith Cimplicity Spinal System |
| PREDICATE DEVICE(S) | SpineSmith Cimplicity Spinal System (K073320)<br>LDR Spine MC+ (K043479)<br>Spinal Elements, Inc. Crystal (K073351) |
| SUBSTANTIAL<br>EQUIVALENCE | The SpineSmith Cimplicity System was determined to be<br>substantially equivalent to several commercially available<br>systems. |

## DEVICE DESCRIPTION

Cimplicity is a rectangular shaped implant, which is available in a parallel or lordotic configuration of various heights. Cimplicity is hollow to allow for the placement of allograft or autograft bone. There vare teeth on the superior and inferior surface of the device to provide increased stability and inhibit movement of the implant.

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### INDICATIONS:

The Cimplicity System is indicated for use to replace a vertebral body that has been resected or excised (i.e. partial or total vertebrectomy) due to tumor or trauma/fracture. The Cimplicity device is intended for use in the thoracolumbar spine (from T1 to L5) and is intended for use with supplemental internal fixation. These devices are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. These devices are intended to be used with autograft or allograft bone.

When used as an intervertebral body fusion device, the Cimplicity System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-TI disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. Cimplicity implants are to be used with autogenous bone graft and implanted via an open, anterior approach.

#### MECHANICAL TEST DATA

Mechanical test results demonstrate that the proposed Cimplicity System is substantially equivalent to the predicate device.

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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 features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The background is white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Spine Smith Partners % Mr. Robert Jones Vice President, Research and Development 8140 North Mopac Building II, Suite 120 Austin, TX 78759

K080971 Re:

> Trade/Device Name: Cimplicity Spinal System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal vertebral body fixation device Regulatory Class: II Product Code: MQP, ODP Dated: April 2, 2008 Received: April 4, 2008

Dear Mr. Jones:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

JUL - 2 2008

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Page 2 - Mr. Robert Jones

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark M. Milliman

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### INDICATIONS FOR USE

510(k) Number (if known): K080971

Device Name:

SpineSmith Partners, LP Cimplicity System

Indications for Use:

The Cimplicity System is indicated for use to replace a vertebral body that has been resected or excised (i.e. partial or total vertebrectomy) due to tumor or trauma/fracture. The Cimplicity device is intended for use in the thoracolumbar spine (from TI to LS) and is intended for use with supplemental internal fixation. These devices are designed to restore the biomechanical integrity of the anterior, middle and posterior spinal column even in the absence of fusion for a prolonged period. These devices are intended to be used with autograft or allograft bone,

When used as an intervertebral body fusion device, the Cimplicity System is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disc disease at one level from the C2-C3 disc to the C7-TI disc. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. Cimplicity imvlants are to be used with autogenous bone graft and implanted via an open, anterior approach. Patients should have at least six weeks of non-operative treatment prior to treatment with a Cimplicity interbody fusion device.

Prescription Use ਮ (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)

| (Division Sign-Off) |
|-----------------------------------|
| Division of General, Restorative, |
| and Neurological Devices |

| 510(k) Number | L08091 |
|---------------|--------|
|---------------|--------|