SPINAL USA ANTERIOR CERVICAL INTERBODY FUSION DEVICE

K083118 · Spinal USA · ODP · May 27, 2009 · Orthopedic

Device Facts

• Record ID: K083118
• Device Name: SPINAL USA ANTERIOR CERVICAL INTERBODY FUSION DEVICE
• Applicant: Spinal USA
• Product Code: ODP · Orthopedic
• Decision Date: May 27, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Spinal USA Interbody Fusion Device ACIF System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. Spinal USA Interbody Fusion Device ACIF implants are used to facilitate fusion in the cervical spine and are placed via an anterior approach at the C-3 to C-7 disc levels using autograft bone. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral fusion device. The device should be used with supplemental fixation.

Device Story

Spinal USA Anterior Cervical Interbody Fusion (ACIF) System consists of PEEK implants of varying heights; designed for anterior cervical spine implantation (C3-C7). Implants are packed with autogenous bone graft to facilitate biologic fusion; provide mechanical support to the disc space until fusion occurs. Used by surgeons in clinical settings; requires supplemental fixation. Benefits include stabilization of the spinal segment in patients with degenerative disc disease.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Material: Medical grade polyetheretherketone (PEEK Optima, LT). Form factor: Interbody spacers of varying heights. Principle: Mechanical support for intervertebral fusion. Supplied non-sterile.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one level (C3-C7) experiencing discogenic pain. Requires six weeks of prior non-operative treatment. Must be used with autograft bone and supplemental fixation.

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

• Novel Cervical Spinal Spacer, Alphatec Spine (K081730)
• Crystal, Spinal Elements (K073351)

Submission Summary (Full Text)

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# 510(k) Summary of Safety and Effectiveness

083118

MAY 27 2009

| Date Summary Prepared: | October 20, 2008 |
|------------------------|-------------------------------------------------------|
| Submitter Information: | Spinal USA<br>2050 Executive Drive<br>Pearl, MS 39208 |
| Contact Name: | Jeffrey Johnson |
| Phone: | 601-420-4244 |
| Fax: | 601-420-5501 |
| E-mail: | [e-mail] |
| Device Trade Name: | Spinal USA Anterior Cervical Interbody Fusion Device |
| Common Name: | Intervertebral Body Fusion Device |
| Regulatory Number: | 888.3080 |
| Classification: | Class II |
| Product Code: | ODP |

### INTENDED USE:

The Spinal USA Interbody Fusion Device ACIF System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. Spinal USA Interbody Fusion Device ACIF implants are used to facilitate fusion in the cervical spine and are placed via an anterior approach at the C-3 to C-7 disc levels using autograft bone. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral fusion device. The device should be used with supplemental fixation.

## DEVICE DESCRIPTION:

The Spinal USA Interbody Fusion Device ACIF System consists of implants with various heights to accommodate individual patient anatomy and graft material size. It is implanted from the anterior approach. It is to be packed with autogenous bone graft to facilitate fusion. The device is intended to provide mechanical support to the implanted level until biologic fusion is achieved. All components are manufactured from medical grade polyetheretherketone (Peek Optima, LT)). The products are supplied clean and "NON-STERILE".

#### PREDICATE DEVICE(S):

The predicate devices previously cleared by FDA are the Novel Cervical Spinal Spacer, Alphatec Spine (K081730), Crystal, Spinal Elements (K073351)

# PERFORMANCE TESTING:

The pre-clinical testing performed indicated that the Spinal USA Interbody Fusion Device ACIF System is substantially equivalent to the predicate devices and is adequate for the intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

MAY 27 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Spinal USA % Mr. Jeffery Johnson 2050 Executive Drive Pearl, Mississippi 39208

Re: K083118

Trade/Device Name: Spinal USA Anterior Cervical Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: ODP Dated: April 20, 2009 Received: April 20, 2009

Dear Mr. Johnson:

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 The The The The The The The The The The The The The The The The The The The general controls provisions of the Act include requirements for annual registration. Iisting 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. Jeffery Johnson

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 Buena

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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K083118
Page 1 of 1

# Indication for Use

#### 1608 3118 510(k) Number (if known):

Device Name: Spinal USA Anterior Cervical Interbody Fusion Device

Indication For Use:

The Spinal USA Interbody Fusion Device ACIF System is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine at one disc level. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. Spinal USA Interbody Fusion Device ACIF implants are used to facilitate fusion in the cervical spine and are placed via an anterior approach at the C-3 to C-7 disc levels using autograft bone. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral fusion device. The device should be used with supplemental fixation.

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

Over the Counter Use _ (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Chun Htin

ivision of Surgical, Orthopedic, and Restorative Devices

510(k) Number K083118