REFLEX HYBRID ACP SYSTEM

K062310 · Stryker Spine · KWQ · Aug 18, 2006 · Orthopedic

Device Facts

• Record ID: K062310
• Device Name: REFLEX HYBRID ACP SYSTEM
• Applicant: Stryker Spine
• Product Code: KWQ · Orthopedic
• Decision Date: Aug 18, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 thefollowing 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 - · Spinal Stenosis

Device Story

Reflex™ Hybrid ACP System is an anterior cervical plate system for spinal fixation; provides temporary stabilization during fusion. System components include metal plates (1 to 4 levels), bone screws (4.0mm/4.5mm, variable/fixed angle, self-drilling/self-tapping), and locking rings. Used by surgeons in clinical/OR settings to stabilize cervical spine (C2-T1). This submission adds three 4-level plate lengths to existing product line. Device functions as mechanical fixation hardware; no electronic or software components. Surgeon implants device to maintain alignment and support bone healing; benefits patient by providing structural stability during fusion process.

Clinical Evidence

No clinical data. Substantial equivalence based on engineering analysis and design comparison to predicate devices.

Technological Characteristics

Spinal intervertebral body fixation orthosis. Components: plates, bone screws, locking rings. Materials identical to predicate. Mechanical fixation device; no energy source, software, or connectivity.

Indications for Use

Indicated for patients requiring temporary anterior cervical spine stabilization (C2-T1) during fusion. Conditions include degenerative disc disease, trauma/fractures, tumors, deformities (kyphosis, lordosis, scoliosis), pseudoarthrosis, failed previous fusion, post-vertebrectomy decompression, spondylolisthesis, and spinal stenosis. Contraindicated for posterior element (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™ Hybrid ACP System (K040261)
• Synthes Cervical Spine Locking Plate System (K000536)
• Synthes Cervical Spine Locking Plate System (K000742)

Submission Summary (Full Text)

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## Special 510(k) Summary of Safety and Effectiveness: Line Extension to the Stryker Spine Reflex™ Hybrid ACP System

| Proprietary Name: | Reflex™ Hybrid ACP System<br>AUG 1 8 2006 |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Anterior Cervical Plate System |
| Proposed Regulatory Class: | Class II<br>Spinal Intervertebral Body Fixation Orthosis,<br>21 CFR 888.3060 |
| Device Product Code: | KWQ |
| Sponsor: | Stryker Spine |
| For Information contact: | Simona Voic<br>Regulatory Affairs Project Manager<br>Stryker Spine<br>2 Pearl Court<br>Allendale, NJ 07401<br>Telephone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Date Summary Prepared: | August 7, 2006 |
| Predicate Device | Reflex™ Hybrid ACP System (K040261)<br>Synthes Cervical Spine Locking Plate System<br>(K000536 and K000742) |

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Intended Use

Device Description

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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 thefollowing 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
- · Spinal Stenosis

The Reflex™ Hybrid ACP System includes plates (1level, 2-level, 3-level, and 4-level), 4.0 mm and 4.5mm diameter bone screws (variable angle self-drilling, variable angle self-tapping, fixed angle self-drilling, and fixed-angle self-tapping), and a locking ring component. This submission adds three new 4-level plate lengths to the Reflex™ Hybrid ACP System.

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Summary of the Technological Characteristics

The intended use and materials of the subject devices are identical to those of the predicate device system. Engineering analysis demonstrated that the subject device system is substantially equivalent in terms of performance characteristics to the predicate device system.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## AUG 1 8 2006

Stryker Spine % Ms. Simona Voic Regulatory Affairs Project Manager 2 Pearl Court Allendale, New Jersey 07401

Re: K062310

Trade/Device Name: Stryker Spine™ Reflex Hybrid ACP System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: August 07, 2006 Received: August 8, 2006

Dear Ms. Voic:

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, and 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 - Ms. Simona Voic

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/industry/support/index.html.

Sincerely yours,

Charles Bullworth

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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## Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Stryker Spine Reflex™ Hybrid 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 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

· 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 X (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)

Senbare michim

(Division Sign-Off)

Division of General, Restorative,

and Neurological Devices

510(k) Number K062310