MODIFICATION TO MACS MODULAR ANTERIOR CONSTRUCT SYSTEM

K032059 · Aesculap, Inc. · KWQ · Jul 25, 2003 · Orthopedic

Device Facts

• Record ID: K032059
• Device Name: MODIFICATION TO MACS MODULAR ANTERIOR CONSTRUCT SYSTEM
• Applicant: Aesculap, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Jul 25, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This anterolateral / anterior system consists of several vertebral screws, locking nuts, spine plates and rods. The points of attachment are screw fixation to the anterolateral vertebral bodies of the lumbar and thoracic spine (T1-L5). This system is intended to provide stabilization during the development of a solid spinal fusion. When used as an anterolateral / anterior spine plate and rod system, the MACS 16 Modular Anterior Construct System is indicated for patients with: Degenerative disk disease defined as back pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies Spondylolisthesis ● Spondylolysis . Fracture . Spinal stenosis . Deformities (i.e., scoliosis, kyphosis, whether neuromuscular or related . to deficient posterior elements) Tumors (neoplastic disease) . Pseudarthrosis . Revision of previous surgery .

Device Story

Modular spinal stabilization system; consists of vertebral screws, locking nuts, spine plates, and rods. Designed for anterolateral/anterior fixation to thoracic and lumbar vertebral bodies (T1-L5). Extension of existing MACSTL system (K002824) adding larger (10mm) polyaxial screws for rescue in poor bone quality and shorter polyaxial screws for thoracic spine. Used by surgeons in clinical settings to provide stabilization during spinal fusion development. Provides mechanical support to the spine; helps maintain alignment during healing.

Clinical Evidence

bench testing only

Technological Characteristics

System components: vertebral screws, locking nuts, spine plates, rods. Materials: metallic (implants). Standards: Conforms to applicable ASTM and ISO standards. Design: Polyaxial screw mechanism. Connectivity: None. Sterilization: Not specified.

Indications for Use

Indicated for patients with degenerative disc disease, spondylolisthesis, spondylolysis, fracture, spinal stenosis, deformities (scoliosis, kyphosis), tumors, pseudarthrosis, or requiring revision surgery, involving the thoracic and lumbar spine (T1-L5).

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

• MACST Modular Anterior Construct System (K002824)
• MACST HMA Anterior Spinal Stabilization System (K011556)
• K-Centrum Anterior Spinal Fixation System (K990959 & K002371)

Submission Summary (Full Text)

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# JUL 25 2003

Image /page/0/Picture/1 description: The image shows the text "K032059" at the top. Below this text, the phrase "Page 1 of 2" is written. The text appears to be handwritten, and the image is a scan or photograph of a document. The page number indicates that this is the first page of a two-page document.

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

in Accordance with SMDA of 1990

#### MACST - Modular Anterior Construct System

July 1, 2003

| COMPANY: | Aesculap®, Inc.<br>3773 Corporate Parkway<br>Center Valley, PA 18034 |
|-----------------|------------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Georg Keller, Regulatory Affairs Manager<br>800-258-1946 (phone)<br>610-791-6882 (fax)<br>[e-mail] (e-mail) |
| TRADE NAME: | MACSTL Modular Anterior Construct System |
| COMMON NAME: | Anterior Lateral Spinal Stabilization System |
| DEVICE CLASS: | Class II |
| PRODUCT CODE: | KWQ |
| CLASSIFICATION: | 888.3060 - Appliance, Fixation, Spinal Intervertebral Body |
| REVIEW PANEL: | Orthopedic |

#### INTENDED USE

This anterolateral / anterior system consists of several vertebral screws, locking nuts, spine plates and rods. The points of attachment are screw fixation to the anterolateral vertebral bodies of the lumbar and thoracic spine (T1-L5). This system is intended to provide stabilization during the development of a solid spinal fusion. When used as an anterolateral / anterior spine plate and rod system, the MACS 16 Modular Anterior Construct System is indicated for patients with:

- Degenerative disk disease defined as back pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies
- Spondylolisthesis ●
- Spondylolysis .
- Fracture .
- Spinal stenosis .
- Deformities (i.e., scoliosis, kyphosis, whether neuromuscular or related . to deficient posterior elements)
- Tumors (neoplastic disease) .
- Pseudarthrosis .
- Revision of previous surgery .

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# DEVICE DESCRIPTION

The MACST Polyaxial Screw and Thoracic Line is an extension of the existing MACSTL implant system, cleared through 510(k) K002824 on May 8, 2001. The extension consists of a larger Polyaxial screw, as well as, a shorter Polyaxial screw for the Thoracic spine. The MACST Polyaxial screw with the larger diameter (10mm) is also designed to work as a rescue screw in poor bone quality.

# PERFORMANCE DATA

No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. The new MACST System conforms to applicable ASTM and ISO standards.

# SUBSTANTIAL EQUIVALENCE

Aesculap believes that the MACST Modular Anterior Construct System Line Extension is substantially equivalent to the existing MACST Modular Anterior Construct System (K002824) and the following other predicate devices:

- MACST HMA Anterior Spinal Stabilization System (K011556) .
- K-Centrum Anterior Spinal Fixation System (K990959 & K002371) .

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 25 2003

Mr. Georg Keller Regulatory Affairs Manager Aesculap, Inc. 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K032059

Trade/Device Name: MACST Modular Anterior Construct System Regulatory Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: June 1, 2003 Received: June 2, 2003

Dear Mr. Keller:

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, 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 - Mr. Georg Keller

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/dsma/dsmamain.html

Sincerely yours,

Sincerely, yours,

Mark McMullen

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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#### INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

K032059

# Device Name: MACST - Modular Anterior Construct System

#### Indication for Use:

This anterolateral / anterior system consists of several vertebral screws, locking nuts, spine plates and rods. The points of attachment are screw fixation to the anterolateral vertebral bodies of the lumbar and thoracic spine (T1-L5). This system is intended to provide stabilization during the development of a solid spinal fusion. When used as an anterolateral / anterior spine plate and rod system, the MACST Modular Anterior Construct System is indicated for patients with:

- Degenerative disk disease defined as back pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies
- Spondylolisthesis .
- Spondylolysis .
- Fracture .
- . Spinal stenosis
- Deformities (i.e., scoliosis, kyphosis, whether neuromuscular or related to . deficient posterior elements)
- Tumors (neoplastic disease) .
- Pseudarthrosis .
- Revision of previous surgery ●

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

| Prescription Use | | or Over-the-Counter Use | |
|----------------------|--|---------------------------|--|
| (per 21 CFR 801.109) | | (Optional Format 3-10-98) | |

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

| 510(k) Number | K032059 |
|---------------|---------|
|---------------|---------|