ABC CERVICAL PLATING SYSTEM

K000486 · Aesculap, Inc. · KWQ · Apr 14, 2000 · Orthopedic

Device Facts

• Record ID: K000486
• Device Name: ABC CERVICAL PLATING SYSTEM
• Applicant: Aesculap, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Apr 14, 2000
• Decision: SESE
• Submission Type: Traditional
• 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 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.

Device Story

ABC Cervical Plating System consists of titanium alloy (Ti6Al4V) bone plates and self-locking bone screws; used for anterior cervical intervertebral body fixation. System includes reusable surgical grade stainless steel instruments. Operated by surgeons in clinical/OR settings to stabilize cervical spine segments. Device provides mechanical fixation to address instability from degenerative disease, trauma, tumors, or revision surgery. Benefits include spinal stabilization and support for fusion.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Implants: Titanium alloy (Ti6Al4V) per ISO 5832/3. Instruments: Surgical grade stainless steel per ISO 7153/1. Mechanical fixation system consisting of plates and self-locking screws. Non-sterile.

Indications for Use

Indicated for patients requiring anterior cervical intervertebral body screw fixation (C2-T1) for cervical spine instability 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

• ABC Cervical Plating System (K974706)
• AcuFix™ Anterior Cervical Plate System (K990005)
• ATLANTIS™ Anterior Cervical Plate System (K993855)
• Blackstone™ Anterior Cervical Plate System (K974885)
• Osteonics ACCP System (K982798, K992344)

Submission Summary (Full Text)

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

### ABC CERVICAL PLATING SYSTEM

February 11, 2000

- Aesculap®, Inc. COMPANY: 1000 Gateway Blvd. So. San Francisco, CA 94080
- CONTACT: Lia S. Jones, Regulatory Associate 650-624-5073 (phone) 650-589-3007 (fax) [e-mail] (email)
- TRADE NAME: ABC Cervical Plating System
- COMMON NAME: Anterior Cervical Screw Spinal Fixation System
- DEVICE CLASS: Class II

PRODUCT CODE: 87 KWQ

CLASSIFICATION: 888.3060 - Spinal Intervertebral Body Fixation Orthosis

REVIEW PANEL: Orthopedic Devices Branch Division of General and Restorative Devices

#### DEVICE DESCRIPTION

The ABC Cervical Plating System consists of two spinal implant components: bone plates and self-locking bone screws. The implants are manufactured from titanium alloy, Ti6Al4V (according to ISO 5832/3) and are provided non-sterile. The specialized ABC instruments are made primarily of surgical grade stainless steel (according to ISO 7153/1) and are hand-held, re-usable devices.

#### INDICATIONS 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.

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# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

in Accordance with SMDA of 1990

## ABC CERVICAL PLATING SYSTEM

February 11, 2000

#### PERFORMANCE DATA

No applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for this device system.

The ABC implants subject to this 510(k) submission, however, were put through various test methods in accordance to applicable ISO / ASTM standards in order to establish their safety and efficacy. The results indicate that the modified and new implants are substantially equivalent to the predicate devices.

#### SUBSTANTIAL EQUIVALENCE

The new and modified components described in this premarket notification are substantially equivalent to those in Aesculap's current ABC Cervical Plating System (K974706) with regard to intended use, fundamental scientific technology, design, and material.

In addition, the following predicate anterior cervical plating systems recently received FDA clearance for similar device modifications and system expansions:

- AcuFix™ Anterior Cervical Plate System (K990005) .
- ATLANTIS™ Anterior Cervical Plate System (K993855) .
- Blackstone™ Anterior Cervical Plate System (K974885) .
- Osteonics ACCP System (K982798, K992344) .

These competitor systems are substantially equivalent to the modified ABC Cervical Plating System with regard to intended use, material composition, labeling, implant size and design.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# APR 1 4 2000

Ms. Lia S. Jones Regulatory Associate Aesculap, Inc. 1000 Gateway Boulevard South San Francisco 94080-7028

Re: K000486 Trade Name: ABC Cervical Plating System Regulatory Class: II Product Code: KWQ Dated: February 11, 2000 Received: February 14, 2000

Dear Ms. Jones:

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 - Ms. Lia S. Jones

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,

Donna R lochner

1/2Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative 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):

K000486

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 (including fractores), posions. 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.

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

Dana R. Lochner.

(Division Sign-Off) Division of General Restorative Devices 510(k) Number_K 000 48 6

Prescription Use

(per 21 CFR 801.109)

or Over-the-Counter Use

(Optional Format 3-10-98)