ABC 2 SCREW

K050813 · Aesculap, Inc. · KWQ · May 4, 2005 · Orthopedic

Device Facts

• Record ID: K050813
• Device Name: ABC 2 SCREW
• Applicant: Aesculap, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: May 4, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ABC Cervical Plating System is intended for the treatment of cervical spine instability resulting from degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), trauma (including fractures), post-traumatic kyphosis or lordosis, tumors, and reoperation for failed previous fusions. Levels of anterior cervical intervertebral body screw fixation for this indication are from C2-T1. WARNING: This device is not approved for screw attachment to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.

Device Story

ABC Cervical Plating System consists of titanium alloy bone plates and self-locking bone screws; used for anterior cervical intervertebral body fixation. Screws feature internal locking mechanism with pin and spring. Implants are non-sterile; specialized instruments are reusable stainless steel. Device used by surgeons in clinical/OR settings to stabilize cervical spine. Provides mechanical fixation to address instability; benefits patient by promoting fusion and restoring spinal alignment.

Clinical Evidence

Bench testing only. No clinical data provided. Mechanical testing performed according to ASTM F2193-02 to demonstrate substantial equivalence.

Technological Characteristics

Materials: Ti6Al4V (ISO 5832/3) for plates and screw bodies; Phynox cobalt alloy (ISO 5832/7) for internal locking mechanism; surgical stainless steel (ISO 7153/1) for instruments. Principle: Mechanical spinal fixation via bone plates and self-locking screws. Form factor: Anterior cervical plating system. Sterilization: Provided non-sterile. Connectivity: None.

Indications for Use

Indicated for patients with cervical spine instability (C2-T1) due to degenerative disc disease, trauma (fractures), post-traumatic kyphosis/lordosis, tumors, or failed previous fusions. 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

• Anterior Cervical Screw Spinal Fixation System (K000486)
• ABC Cervical Plating System (K974706)

Submission Summary (Full Text)

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# KOSO813

# MAY = 4 2005

Page 1 of 2

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS in Accordance with SMDA of 1990

# 2ND GENERATION SCREW, ABC CERVICAL PLATING SYSTEM (ABC 2

### SCREW)

March 29, 2005

- Aesculap®, Inc. COMPANY: 3773 Corporate Parkway Center Valley, PA 18034
- CONTACT: Kathy A. Racosky, Regulatory Affairs Associate 800-258-1946 (phone) 610-791-6882 (fax) [e-mail] (email)
- ABC Cervical Plating System (ABC 2 Screw) TRADE NAME:
- COMMON NAME: Anterior Cervical Screw Spinal Fixation System
- DEVICE CLASS: Class II

PRODUCT CODE: KWQ

- CLASSIFICATION: 888.3060 - Appliance, Fixation, Spinal Intervertebral Body
REVIEW PANEL: Orthopedics

#### INTENDED USE

The ABC Cervical Plating System is intended for the treatment of cervical spine instability resulting from degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), trauma (including fractures), post-traumatic kyphosis or lordosis, tumors, and reoperation for failed previous fusions. Levels of anterior cervical intervertebral body screw fixation for this indication are from C2-T1.

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

#### DEVICE DESCRIPTION

The ABC Cervical Plating System consists of two spinal implant components: bone plates and bone screws. Both implants are manufactured from titanium alloy, Ti6Al4V according to ISO 5832/3 and are provided non-sterile. The 200 generation screw will be self-locking with an internal locking pin and spring.

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KOSO813

The outer body of the 2nd generation screw is still manufactured from Ti6Al4V while the internal locking mechanism is made from Phynox (cobalt alloy) per ISO 5832/7. The specialized ABC instruments are made primarily of surgical grade stainless steel according to ISO 7153/1 and are hand-held, re-usable devices.

#### PERFORMANCE DATA

No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. The ABC system was tested according to ASTM F2193-02 and the results demonstrated substantial equivalence to the predicate device.

#### SUBSTANTIAL EQUIVALENCE

Aesculap believes that the 200 Generation Screw for the ABC Cervical Plating System (ABC 2 Screw) is substantially equivalent to screws cleared for our current Anterior Cervical Screw Spinal Fixation System (K000486). Plates and Screws for the ABC System were originally cleared in K974706.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a bird in flight, composed of three curved lines.

MAY - 4 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Kathy A. Racosky Regulatory Affairs Associate Aesculap, Inc. 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K050813

Trade/Device Name: ABC Cervical Plating System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: April 18, 2005 Received: April 19, 2005

Dear Ms. Racosky:

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 for ass build in the 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 r reaso oo aar 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 or any 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. Kathy A. Racosky

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to organ maning of substantial equivalence of your device to a legally premarket nonneation: "The Pets 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 If you desire specific acritor 10- 9 at [phone] . Also, please note the regulation entitled, Connect the Ories of Course to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational 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,

Stupt Rhodes

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

#### Device Name: ABC Cervical Plating System

#### Indication for Use:

The ABC Cervical Plating System is intended for the treatment of cervical spine instability resulting from degenerative disc disease (defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies), trauma (including fractures), post-traumatic kyphosis or lordosis, tumors, and re-operation for failed previous fusions. Levels of anterior cervical intervertebral body screw fixation for this indication are from C2-T1.

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

Prescription Use or Over-the-Counter Use

(per 21 CFR 801.109)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Styke Rhodes

(Division Sign-Off) Division of General. Restorative. and Neurological Devices

K050813 510(k) Number_