CAMBRIA

K082309 · Seaspine, Inc. · ODP · Apr 9, 2009 · Orthopedic

Device Facts

• Record ID: K082309
• Device Name: CAMBRIA
• Applicant: Seaspine, Inc.
• Product Code: ODP · Orthopedic
• Decision Date: Apr 9, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Cambria is intended to be used as an adjunct to spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain with discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Patients should have received at least six weeks of non-operative treatment prior to treatment with the device. Devices are intended to be implanted via an open, anterior approach and used with autogenous bone and supplemental fixation, such as an anterior plating system.

Device Story

Cambria is an intervertebral fusion device acting as a disc spacer to hold bone graft and promote fusion in the cervical spine. The device is box-shaped with a central canal for bone graft and includes radiographic markers. It is implanted by a surgeon via an open, anterior approach. The device is used as an adjunct to spinal fusion procedures at one level (C3-C7) in conjunction with autogenous bone and supplemental fixation (e.g., anterior plating system). It provides structural support to the intervertebral space to facilitate fusion in patients with degenerative disc disease.

Clinical Evidence

Bench testing only; no clinical data required.

Technological Characteristics

Materials: PEEK (polyetheretherketone) with radiographic markers. Form factor: Box-shaped intervertebral spacer with central canal. Energy source: None (mechanical). Sterilization: Not specified.

Indications for Use

Indicated for skeletally mature patients with cervical degenerative disc disease (C3-C7) presenting with neck pain of discogenic origin confirmed by history and imaging. Requires at least six weeks of prior non-operative treatment. Used with autogenous bone and supplemental anterior plating.

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.

Submission Summary (Full Text)

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## 510(k) Summary

| Company Name: | SeaSpine, Inc.<br>2302 La Mirada Drive<br>Vista, CA 92081 | |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Person: | Jeff Brittan<br>Senior Project Engineer<br>E-mail: [e-mail]<br>Phone: [phone], Fax: [phone] | APR 10 2009 |
| Date Prepared: | August 11, 2008 | |
| Trade Name: | Cambria™ | |
| Common Name:<br>Classification Name: | Interbody Fusion Device<br>Intervertebral Fusion Device with Bone Graft, Cervical<br>21 CFR 888.3080, Product Code ODP, Class II<br>Orthopedic Review Committee | |
| Device Description: | Cambria is an intervertebral fusion device intended to act as a disc spacer and<br>hold bone graft to promote fusion in the cervical spine. Implants are made from<br>PEEK (polyetheretherketone) with radiographic markers and are generally box-<br>shaped with a central canal for receiving bone graft. Cambria is offered in a<br>variety of shapes and sizes to accommodate variations in patient anatomy. | |
| Intended Use: | Cambria is intended to be used as an adjunct to spinal fusion procedures at one<br>level (C3-C7) in skeletally mature patients with degenerative disc disease<br>(defined as neck pain with discogenic origin with degeneration of the disc<br>confirmed by history and radiographic studies) of the cervical spine. Patients<br>should have received at least six weeks of non-operative treatment prior to<br>treatment with the device. Devices are intended to be implanted via an open,<br>anterior approach and used with autogenous bone and supplemental fixation,<br>such as an anterior plating system. | |
| Substantial<br>Equivalence: | Cambria was shown to be substantially equivalent to predicate device(s)<br>through comparison in areas including intended use, design, materials, and<br>function. | |
| Performance Data: | Mechanical testing results indicated that Cambria possessed appropriate<br>properties for its intended use and is substantially equivalent to predicate<br>device(s). Clinical data was not required for this device. | |

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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 & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

APR 1 0 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SeaSpine, Inc. % Mr. Jeff Brittan Senior Project Engineer 2302 La Mirada Drive Vista, California 92081

Re: K082309

Trade/Device Name: Cambria™ Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: March 17, 2009 Received: March 18, 2009

Dear Mr. Brittan:

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 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. Jeff Brittan

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 the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 yours,

Barbara Bush

Mark N. Melkerso 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): K082309

Device Name: Cambria™

Indications for Use:

Cambria is intended to be used as an adjunct to spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain with discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Patients should have received at least six weeks of non-operative treatment prior to treatment with the device. Devices are intended to be implanted via an open, anterior approach and used with autogenous bone and supplemental fixation, such as an anterior plating system.

Prescription Use __ × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(Please DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Clarbare Brennd

and Neurological Devices

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**510(k) Number** K082309