CYCLONE ANTERIOR CERVICAL PLATE SYSTEM

K031214 · Encore Medical L.P. · KWQ · Sep 23, 2003 · Orthopedic

Device Facts

• Record ID: K031214
• Device Name: CYCLONE ANTERIOR CERVICAL PLATE SYSTEM
• Applicant: Encore Medical L.P.
• Product Code: KWQ · Orthopedic
• Decision Date: Sep 23, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cyclone™ Anterior Cervical Plate System is intended to provide stabilization during the process of cervical spinal fusion (C2-C7) in patients with degenerative disc disease (as defined by neck pain of discogenic origin of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and/or failed previous fusions.

Device Story

Cyclone™ Anterior Cervical Plate System is a spinal fixation orthosis. Device consists of titanium alloy (ASTM F136) cervical plates with pre-assembled locking mechanisms and unicortical screws. Plates available in one-level to three-level fusion configurations (14mm-69mm). Screws provided in standard (4mm diameter) and rescue (4.4mm diameter) sizes. Used by surgeons in clinical settings to provide stabilization during cervical spinal fusion procedures. Device functions as a mechanical construct to immobilize spinal segments, facilitating fusion and potentially reducing pain and deformity in patients with degenerative, traumatic, or neoplastic spinal conditions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Titanium alloy (ASTM F136) cervical plates and unicortical screws. Mechanical fixation via pre-assembled locking mechanism. Plate lengths 14mm-69mm; screw diameters 4mm (standard) and 4.4mm (rescue).

Indications for Use

Indicated for patients (C2-C7) requiring cervical spinal fusion stabilization due to degenerative disc disease, trauma (fractures), tumors, deformity (kyphosis, lordosis, scoliosis), pseudoarthrosis, or failed previous fusions.

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

• Trinica Select Anterior Cervical Plate (K022344)
• Zephir Anterior Cervical Plate (K994239)

Submission Summary (Full Text)

{0}------------------------------------------------

SEP 2 3 2003

# 510(k) Summary of Safety and Effectiveness

031214
page 1 of 1

- (1) Submitter's name: Submitter's address: Submitter's telephone number: Contact person: Date summary prepared:
Encore Medical, L.P. 9800 Metric Blvd, Austin, TX 78758 [phone] Debbie De Los Santos April 15, 2003

- Cyclone™ Anterior Cervical Plate Trade or proprietary device name: (2) Svstem Anterior Cervical Plate Common or usual name: 888.3060 - Spinal Intervertebral Body Classification name: Fixation Orthosis
- Predicate devices: (3)

Trinica Select Anterior Cervical Plate Zephir Anterior Cervical Plate

#### (4) Subject device description:

The Cyclone™ Anterior Cervical Plate System is a fixation device consisting of cervical plates (locking mechanism is pre-assembled to plates) and unicortical screws made from titanium alloy in conformance with ASTM F136. The plates are offered in one-level, two-level, and three-level fusion configurations (14mm-69mm). There are four different lengths of the standard 4mm diameter screw (12, 14, 16, and 18mm). The rescue screw has a diameter of 4.4mm and lengths are 12, 14 and 16mm.

#### (5) Subiect device intended use:

The Cyclone™ Anterior Cervical Plate System is intended to provide stabilization during the process of cervical spinal fusion (C2-C7) in patients with degenerative disc disease (as defined by neck pain of discogenic origin of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and/or failed previous fusions.

#### Basis for Substantial Equivalence: (6)

The Cyclone™ Anterior Cervical Plate System is similar in design, indications and materials to Centerpulse Spine-Tech's Trinica Select Anterior Cervical Plate (K022344) and Medtronic Sofamor Danek's Zephir Anterior Cervical Plate (K994239).

{1}------------------------------------------------

510(k) Number (if known): __

Device Name:

Indications For Use:

## Cyclone™ Anterior Cervical Plate System Indications For Use

The Cyclone™ Anterior Cervical Plate System is intended for anterior Inter-body screw fixation to provide stabilization of cervical spinal fusion (C2-C7). This system is indicated for use in patients with degenerative disc disease (as defined by neck paln of discogenic origin of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scollosis), pseudoarthrosis, and/or failed previous fusions.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _____________________________________________________________________________________________________________________________________________________________

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

KUZZIZIY

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with stylized lines representing its wings and body.

Public Health Service

SEP 2 3 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Debbie De Los Santos Supervisor. Regulatory/Clinical Services Encore Medical, L.P. 9800 Metric Boulevard Austin, TX 78758

Re: K031214 Trade/Device Name: Cyclone™ Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: April 16, 2003 Received: July 10, 2003

Dear Ms. De Los Santos:

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.

{3}------------------------------------------------

### Page 2 - Ms. Debbie De Los Santos

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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html

Sincerely yours,

Mark N Millkum

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Cyclone™ Anterior Cervical Plate System Device Name:

Indications For Use:

### Cyclone™ Anterior Cervical Plate System Indications For Use

The Cyclone™ Anterior Cervical Plate System is intended to provide stabilization during the process of cervical spinal fusion (C2-C7) in patients with degenerative disc disease (as defined by neck pain of discogenic origin of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudoarthrosis, and/or failed previous fusions.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | OR | Over-The-Counter Use |
|----------------------|----|--------------------------|
| (per 21 CFR 801.109) | | (Optional Format 1-2-96) |

for

(Division Sign-Off)

Division of General, Restorative and Neurological Devices

| 510(k) Number | K031214 |
|---------------|---------|
|---------------|---------|