CIMPLICITY SPINAL SYSTEM

K073320 · Spine Smith Partners L.P. · ODP · Feb 7, 2008 · Orthopedic

Device Facts

• Record ID: K073320
• Device Name: CIMPLICITY SPINAL SYSTEM
• Applicant: Spine Smith Partners L.P.
• Product Code: ODP · Orthopedic
• Decision Date: Feb 7, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cimplicity Spinal Fixation 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.

Device Story

Cimplicity Spinal Fixation System; rectangular, hollow interbody fusion device; designed for anterior cervical interbody fusion. Implanted via open, anterior approach by surgeons; used with autogenous bone graft to facilitate fusion. Provides structural support in cervical spine at one level (C2-C3 to C7-T1) for patients with symptomatic nerve root or spinal cord compression. Benefits include stabilization of vertebral segments to alleviate radiculopathy/myelopathy symptoms.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and comparison of mechanical properties and material composition.

Technological Characteristics

Rectangular, hollow interbody fusion device; constructed from PEEK; includes tantalum beads for radiographic visualization. Implanted via open, anterior approach.

Indications for Use

Indicated for skeletally mature patients with cervical disc disease (intractable radiculopathy/myelopathy, herniated disc, osteophyte formation) at one level (C2-C3 to C7-T1) requiring anterior cervical interbody fusion. Requires 6 weeks prior nonoperative treatment.

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

• Affinity Cervical Cage (P000028)

Submission Summary (Full Text)

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# 510(k) Summary

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| Date Submitted: | November 21, 2007 | |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------|
| Manufacturer: | SpineSmith USA<br>5300 N. Lamar, Suite 107<br>Austin, TX 78751 | FLE 7 |
| Contact Name: | Robert Jones | |
| Phone: | 512-302-0086 | |
| Device Trade Name: | Cimplicity | |
| Common Name: | Interbody Fusion Device | |
| Regulatory Class: | 888.3080 | |
| Classification Code: | Class II | |
| Product Code: | ODP | |
| Predicate Devices: | Affinity Cervical Cage (P000028) and others. | |
| Device Description: | The Cimplicity system is a rectangular interbody fusion device. The<br>device is hollow and may be filled with graft material. Various sizes<br>are provided to accommodate patient anatomy. | |
| Intended Use: | The Cimplicity Spinal Fixation System is indicated for anterior cervical<br>interbody fusion procedures in skeletally mature patients with cervical<br>disc disease at one level from the C2-C3 disc to the C7-T1 disc.<br>Cervical disc disease is defined as intractable radiculopathy and/or<br>myelopathy with herniated disc and/or osteophyte formation on<br>posterior vertebral endplates producing symptomatic nerve root and/or<br>spinal cord compression confirmed by radiographic studies. Cimplicity<br>implants are to be used with autogenous bone graft and implanted via<br>an open, anterior approach. | |
| Materials: | Cimplicity is made from PEEK and has tantalum beads used for<br>radiographic visualization. | |
| Substantial Equivalence: | The Cimplicity Spinal System was tested and compared to predicate<br>devices and found to be substantially equivalent in terms of intended<br>use, mechanical properties and material composition. | |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a representation of human services, featuring three overlapping, curved lines.

Public Health Service

FEB - 7 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Spine Smith Partners L.P. % Mr. Robert Jones Vice President, Research and Development 5300 North Lamar Boulevard #107 Austin, Texas 78751

Re: K073320

Trade/Device Name: Cimplicity Spinal Fixation System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: January 11, 2008 Received: January 14, 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.

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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 its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mark N. Wilkinson

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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## Statement of Indications for Use

#### 510(k) Number: K073320

### Device Name: Cimplicity Spinal Fixation System

#### Indications for Use:

The Cimplicity Spinal Fixation 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 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 nonoperative treatment prior to treatment with an intervertebral cage.

Prescription Use X

OR

Over the counter

(Per 21 CFR 801.109)

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

Soubara Boucher

Division of General, Restorative. and Neurological Devices

510(k) Number R073320