PHENIX CERVICAL INTERBODY DEVICE

K083167 · Spinal Devices, LLC · ODP · Jan 13, 2009 · Orthopedic

Device Facts

• Record ID: K083167
• Device Name: PHENIX CERVICAL INTERBODY DEVICE
• Applicant: Spinal Devices, LLC
• Product Code: ODP · Orthopedic
• Decision Date: Jan 13, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Phenix Cervical Interbody Device (Phenix CID) 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. Phenix CID 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 received 6 weeks of non-operative treatment prior to treatment with the devices. The device should be used with supplemental fixation.

Device Story

Phenix Cervical Interbody Device (CID) is a spinal fusion implant; constructed from PEEK Optima. Implanted via anterior approach at C3-C7 levels; packed with autogenous bone graft to facilitate fusion. Provides mechanical support to the disc space until biologic fusion occurs. Used by surgeons in clinical settings. Requires supplemental fixation. Benefits patients by stabilizing the spinal segment to alleviate discogenic pain.

Clinical Evidence

Bench testing only.

Technological Characteristics

Material: PEEK Optima. Form factor: Cervical interbody fusion device with various geometries. Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for skeletally mature patients with cervical degenerative disc disease (DDD) at one level (C3-C7) experiencing discogenic pain confirmed by history and radiography. Requires 6 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

• BAC/Cervical Implant (P980048)
• Medicrea IMPIX Interbody Device (K072226)

Submission Summary (Full Text)

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K083167 Page (off)

# 4. 510(k) Summary according to 807.92(c)

| Contact: | Tim Lusby<br>Spinal Devices TM, LLC<br>1155 Allgood Road, Suite 6<br>Marietta, GA 30062<br>770-874-0935 | JAN 13 2009 |
|-----------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Trade Name:<br>Product Class:<br>Classification:<br>Product Codes:<br>Panel Code: | Phenix ® Cervical Interbody Device (Phenix ® CID)<br>Class II<br>888.3080<br>ODP<br>87 | |
| Indications for Use: | The Phenix Cervical Interbody Device (Phenix CID) is indicated<br>for use in skeletally mature patients with degenerative disc disease<br>(DDD) of the cervical spine at one disc level. DDD is defined as<br>discogenic pain with degeneration of the disc confirmed by history<br>and radiographic studies. Phenix CID implants are used to<br>facilitate fusion in the cervical spine and are placed via an anterior<br>approach at the C-3 to C-7 disc levels using autograft bone.<br>Patients should have received 6 weeks of non-operative treatment<br>prior to treatment with the devices. The device should be used<br>with supplemental fixation. | |
| Device Description: | The Phenix ® Cervical Interbody Device is a cervical interbody<br>fusion device made from PEEK Optima. It is implanted from the<br>anterior approach. The device is provided in various geometries<br>and is designed to fit within the outer cortex of cervical spine<br>vertebrae. It is to be packed with autogenous bone graft to<br>facilitate fusion. The device is intended to provide mechanical<br>support to the implanted level until biologic fusion is achieved. | |
| Predicate Device(s): | The predicate devices previously cleared by FDA are the<br>BAC/Cervical Implant from Zimmer Spine (previously approved<br>as a PMA product under the name of Spine-Tech) (P980048), and<br>the Medicrea IMPIX Interbody Device (K072226). | |
| Performance Testing: | The pre-clinical testing performed indicated that the Phenix CID is<br>substantially equivalent to the predicate devices and is adequate for<br>the intended use. | |

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the caduceus.

#### Public Health Service

JAN 1 C 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Spinal Devices™, LLC % Mr. Tim Lusby 1155 Allgood Road, Suite 6 Marietta, Georgia 30062

Re: K083167

Trade/Device Name: Phenix® Cervical Interbody Device (Phenix® CID) Regulation Number: 21 CFR 888,3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: ODP Dated: December 12, 2008 Received: December 16, 2008

Dear Mr. Lusby:

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. Tim Lusby

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 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 N Mullican

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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# 3. Statement of Indications for Use

510(k) Number: 083167

Indications for Use: The Phenix Cervical Interbody Device (Phenix CID) 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. Phenix CID 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 received 6 weeks of non-operative treatment prior to treatment with the devices. The device should be used with supplemental fixation.

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)

Mark A. Milkerson

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

**510(k) Number** K083167

Concurrence of CDRH, Office of Device Evaluation (ODE)