REFLEX HYBRID ANTERIOR CERVICAL PLATE SYSTEM

K040261 · Stryker Spine · KWQ · Apr 16, 2004 · Orthopedic

Device Facts

• Record ID: K040261
• Device Name: REFLEX HYBRID ANTERIOR CERVICAL PLATE SYSTEM
• Applicant: Stryker Spine
• Product Code: KWQ · Orthopedic
• Decision Date: Apr 16, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Reflex" ACP System and Reflex " Hybrid ACP System are intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1.

Device Story

Reflex™ Hybrid Anterior Cervical Plate System is a low-profile, unilateral fixation implant system; consists of titanium alloy bone plates and screws in various lengths to accommodate patient anatomy. Used by surgeons in clinical settings for temporary stabilization of the anterior cervical spine (C2-T1) during fusion procedures. Implants are provided non-sterile; require surgical implantation. Device provides mechanical support to the spinal column to facilitate fusion; helps restore stability in patients with degenerative, traumatic, or structural spinal conditions. Output is physical fixation of vertebral bodies.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Materials: Titanium alloy per ASTM F-136 and ISO 5832-3. Form factor: Low-profile anterior cervical plate system for unilateral fixation. Provided non-sterile. No software or electronic components.

Indications for Use

Indicated for temporary stabilization of the anterior spine during cervical fusion in patients with degenerative disc disease, trauma (fractures), tumors, deformities (kyphosis, lordosis, scoliosis), pseudoarthrosis, failed previous fusion, post-vertebrectomy decompression, spondylolisthesis, or spinal stenosis. Not for posterior pedicle screw attachment.

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

• Reflex Anterior Cervical Plate System (K040261)

Submission Summary (Full Text)

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

# Special 510(k) Summary of Safety and Effectiveness: Line extension to the Reflex Anterior Cervical Plate System

| Proprietary Name: | Reflex™ Hybrid Anterior Cervical Plate System |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Anterior Cervical Plate System |
| Proposed Regulatory Class: | Class II |
| Classification Name and Reference: | Spinal Invertebral Body Fixation Orthosis<br>21 CFR §888.3060 |
| Device Product Code: | 87 KWQ: Appliance, Fixation, Spinal Intervertebral Body |
| For Information contact: | Simona Voic |
| | Regulatory Affairs Project Manager |
| | Stryker Spine |
| | 6 Pearl Court<br>Allendale, NJ 07401-1677<br>Telephone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Summary Prepared: | January 27, 2004 |

### Predicate Device Information:

Stryker Spine's Reflex " Anterior Cervical Plate System consists of bone plates and screws. Both components are available in a variety of lengths in order to accommodate patient physiology. The components are fabricated from titanium alloy per ASTM F-136, ISO 5832-3 and ASTM F-1813. The implants are provided non-sterile.

#### Description of Device Modification

This submission is intended to expand the Reflex " ACP System product line by adding the Reflex" Hybrid ACP System, a low profile anterior cervical plate system, intendcd for unilateral fixation. Similar to its predicate device, the Reflex " Hybrid ACP System consists of bonc plates and screws, available in a variety of lengths. The components of the subject device are fabricated from Titanium alloy as described in ASTM F-136 and ISO 5832-3. The Reflex™ Hybrid ACP System will be provided non-sterile.

#### Intended Use:

The Reflex" ACP System and Reflex " Hybrid ACP System are intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1.

#### Indication for Use:

The Reflex " ACP System and Reflex" Hybrid ACP System are indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications: Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), trauma (including fractures), tumors, deformities or curvatures (including kyphosis, lordosis or scoliosis), pseudoarthrosis, failed previous fusion, decompression of the spinal cord following total or partial cervical vertebrectomy, spondylolisthesis and spinal stenosis.

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

K040261

- This device is not approved for screw attachment to the posterior elements WARNING: (pedicles) of the cervical, thoracic, or lumbar spine.
# Statement of Technological Comparison:

Equivalency of the Reflex " Hybrid ACP System is based on similarities in intended use, indications for use, materials, and design to the predicate device. Testing has been conducted demonstrating substantial equivalence to the predicate device.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

DEPARTMENT

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 6 2004

Mr. Christopher McDonnell Vice President Global Technology Stryker Spine 6 Pearl Court Allendale, NJ 07401-1677

Re: K040261

Trade/Device Name: Reflex™ Hybrid Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: February 3, 2004 Reccived: February 4, 2004

Dear Mr. McDonnell:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your been be and the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of the enactment date of the Medical Device Amendments, or to commerce prof to this 2011-07-12, in accordance with the provisions of the Federal Food, Drug, de rices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The Tournal controls provisions of the Act include requirements for annual registration, listing of general controll province, 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 may be subject to back as a segulations, 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 r lease be devices and i termination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I oderal 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 Erth 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 -- Mr. Christopher McDonnell

This letter will allow you to begin marketing your device as described in your Section 510(k) I mo letet 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" (21 CFR 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 vours.

Sincerely, John,

Mark McMillan

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}------------------------------------------------

# Indications for Use

## 510(k) Number (if known): K040261

Device Name: Reflex™ Hybrid Anterior Cervical Plate (ACP) System

Indications For Use:

The Reflex™ Hybrid ACP System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:

- Degenerative Disc Disease (as defined by neck pain of discogenic origin with � degeneration of the disc confirmed by history and radiographic studies)
- Trauma (including fractures) .
- Tumors .
- Deformities or curvatures (including kyphosis, lordosis or scoliosis) .
- Pseudoarthrosis .
- Failed previous fusion .
- Decompression of the spinal cord following total or partial cervical vertebrectorny. .
- Spondylolisthesis ●
- Spinal Stenosis .

WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) |
|---------------------|

Division of General Restorative,
and Neurological Devices

| 510(k) Number | K040261 |
|---------------|---------|
| Page 1 of | 1 |