DELTALOC ANTERIOR CERVICAL PLATE SYSTEM

K993513 · Alphatec Mfg., Inc. · KWQ · Apr 26, 2000 · Orthopedic

Device Facts

• Record ID: K993513
• Device Name: DELTALOC ANTERIOR CERVICAL PLATE SYSTEM
• Applicant: Alphatec Mfg., Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Apr 26, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Deltaloc Anterior Cervical Plate System is indicated for use in the anterior cervical spine (C2-C7); patients with trauma (including fractures), spondylolisthesis, degenerative spondylosis, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, and tumors.

Device Story

Deltaloc Anterior Cervical Plate System is a spinal fixation orthosis; consists of titanium plates and titanium alloy (Ti-6Al-4V) screws. Plates feature radial and lordotic curvature with deformable tabs at screw holes to capture screws and prevent digression. Screws available in fixed or variable angles relative to plate. Used by surgeons in clinical settings for anterior cervical spine stabilization (C2-C7) to facilitate fusion. Device provides mechanical support to the spine; helps maintain alignment during healing process; benefits patients by stabilizing vertebral segments affected by trauma, degeneration, or tumors.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Commercially pure titanium plates; Ti-6Al-4V titanium alloy screws. System includes plates with varying screw holes and screws with fixed or variable angle options. Mechanical fixation via deformable tab locking mechanism. Non-powered, manual surgical instrumentation.

Indications for Use

Indicated for patients (C2-C7) with trauma (fractures), spondylolisthesis, degenerative spondylosis, degenerative disc disease (discogenic pain confirmed by history/radiography), spinal stenosis, and tumors.

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

• Synthes CSLP (Cervical Spine Locking Plate) System

Submission Summary (Full Text)

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APR 2 6 2000

Manufacturer Identification

Premarket Notification Interior Cervical Plate System hater Manufacturing, Inc.

# 510(k) Summary

#### 510(k) Number K993513

### Alphatec Manufacturing, Inc. Submitted By: 42-160 State Street Palm Desert, CA 92211 phone: [phone] [phone] fax: Contact Person: Jason Blain Manager of Product Development Date Summary Prepared: January 24, 2000 Device Identification Deltaloc Anterior Cervical Plate System Proprietary Name: Spinal Intervertebral Body Fixation Orthosis Common Name: 21 CFR 888.3060: Appliance, Fixation, Spinal, Classification: Intervertebral Body

#### Device Description

The Deltaloc Anterior Cervical Plate System consists of plates and screws that are used for attachment to the anterior cervical spine. Plates are offered in a variety of sizes with varying numbers of screw holes to accommodate single to quadruple level fusions. Plates are shaped with both radial and lordotic curvature and contain a deformable tab at each screw hole to capture the screws to the plate, preventing screw digression. Screws are offered in two diameters and four lengths per diameter. All screws are also available so that their angle relative to the plate is fixed or variable.

The plates of the Deltaloc Anterior Cervical Plate System are manufactured from commercially pure titanium and the screws are manufactured from titanium alloy (Ti-6Al-4V).

#### Intended Use of the Device

The Deltaloc Anterior Cervical Plate System is indicated for: use in the anterior cervical spine (C2-C7); patients with trauma (including fractures), spondylolisthesis, degenerative spondylosis, degenerative disc disease (defined as back pain of discogenic origin with

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degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, and tumors.

#### Substantial Equivalence

The Deltaloc Anterior Cervical Plate System is substantially equivalent to the Synthes CSLP (Cervical Spine Locking Plate) System. The Deltaloc Anterior Cervical Plate System is similar to the listed predicate device in design, function, materials used, and indications for use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the department's name around the perimeter. In the center of the logo is a stylized symbol that resembles a bird or a person with outstretched arms. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# APR 2 6 2000

Mr. Jason Blain Alphatec Manufacturing Inc 42-160 State Street Palm Desert, California 92211

Re: K993513

Trade Name: Deltaloc Anterior Cervical Plate System Regulatory Class: II Product Code: KWQ Dated: January 24, 2000 Received: January 27, 2000

Dear Mr. Blain:

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 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 control provisions of the Act. The general control 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 requirement, 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.

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.

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Page 2 - Mr. Jason Blain

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" (21 CFR 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 at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Dune R. Lochner

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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### Intended Uses/Indications

510(k) Number: K993513

Device Name: Detaloc Anterior Cervical Plate System

Indications for Use:

The Deltaloc Anterior Cervical Plate System is indicated for use in the anterior cervical spine (C2-C7); patients with trauma (including fractures), spondylolisthesis, degenerative spondylosis, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spinal stenosis, and tumors.

Dumas R. Lochner.

510(k) Number