REFLEX ANTERIOR CERVICAL PLATE SYSTEM

K010115 · Howmedica Osteonics Corp. · KWQ · Apr 16, 2001 · Orthopedic

Device Facts

• Record ID: K010115
• Device Name: REFLEX ANTERIOR CERVICAL PLATE SYSTEM
• Applicant: Howmedica Osteonics Corp.
• Product Code: KWQ · Orthopedic
• Decision Date: Apr 16, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Reflex Anterior Cervical Plate (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 and decompression of the spinal cord following total or partial cervical vertebrectomy. WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Device Story

Reflex Anterior Cervical Plate (ACP) System; orthopedic implant for spinal fixation. Components: titanium alloy bone plates with preassembled anti-migration mechanism and screws. Used by surgeons in clinical settings for temporary stabilization of anterior cervical spine (C2-T1) during fusion procedures. Provides mechanical support to spinal column; facilitates stabilization in patients with degenerative disease, trauma, tumors, or deformities. Implanted via surgical procedure; provides structural integrity to aid bone healing. Non-sterile delivery; requires sterilization before use.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Materials: Titanium alloy per ASTM F-136, ISO 5832-3, and ASTM F-1813. Components: Bone plates with preassembled anti-migration mechanism and screws. Form factor: Variable lengths to accommodate patient physiology. Non-sterile.

Indications for Use

Indicated for patients requiring temporary anterior cervical spine stabilization (C2-T1) during fusion. Conditions include degenerative disc disease, trauma/fractures, tumors, spinal deformities (kyphosis, lordosis, scoliosis), pseudoarthrosis, failed previous fusion, and decompression following vertebrectomy. Contraindicated for posterior element (pedicle) 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

• North ACP (K955621)

Submission Summary (Full Text)

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K010115

510(k) Premarket Notification

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# APR 1 6 2001

### 510(k) Summary of Safety and Effectiveness for the Reflex Anterior Cervical Plate System

Proprietary Name: Common Name: Classification Name and Reference

Regulatory Class: Device Product Code: For Information contact:

Reflex Anterior Cervical Plate System Anterior Cervical Plate System Spinal Invertebral Body Fixation Orthosis 21 CFR 8888.3060 Class II 87 KWQ Karen Ariemma, Regulatory Affairs Specialist Howmedica Osteonics Corp. 59 Route 17 Allendale, NJ 07401-1677 Phone: [phone] Fax: [phone] January 12, 2001

Date Summary Prepared:

#### Intended Üse:

The Reflex Anterior Cervical Plate (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 and decompression of the spinal cord following total or partial cervical vertebrectomy.

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

#### Description:

The Reflex ACP System consists of a bone plates (an anti-migration mechanism is preassembled to 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 as described in ASTM F-136, ISO 5832-3 and ASTM F-1813. The implants will be provided nonsterile.

#### Substantial Equivalence:

Equivalency of this device is based on similarities in intended use, materials, and design to other currently marketed anterior cervical plate systems. Testing has been conducted demonstrating substantial equivalence to a currently marked device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 6 2001

Ms. Karen Ariemma Regulatory Affairs Specialist Howmedica Osteonics Corporation 59 Route 17 Allendale, New Jersey 07401-1677

Re: K010115

Trade/Device Name: Reflex Anterior Cervical Plate System Regulation Number: 888.3060 Regulatory Class: II Product Code: KWQ Dated: April 1, 2001 Received: April 16, 2001

Dear Ms. Ariemma:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controls Connisions 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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### Page 2 - Ms. Karen Ariemma

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 Millman

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

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510(k) Number (if known): K_

Device Name: Reflex Anterior Cervical Plate System

The Reflex ACP System is intended for anterior intervertebral screw fixation of the cervical The North ACP 2556211 is indicated for temporary stabilization of the anterior spine Spine at levelopment of cervical spine fusions in patients with the following indications:

- mg the development of very (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 .
- I and provious rations .

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

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Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The-Counter Use OR Prescription Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Mark N. Millhurn

rision Division of General, Restorative and Neurological Devices

510(k) Number K010115