MACS HMA ANTERIOR SPINAL STABILIZATION SYSTEM

K011556 · Aesculap, Inc. · KWQ · Nov 16, 2001 · Orthopedic

Device Facts

• Record ID: K011556
• Device Name: MACS HMA ANTERIOR SPINAL STABILIZATION SYSTEM
• Applicant: Aesculap, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Nov 16, 2001
• Decision: SESE
• Submission Type: Traditional
• 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 (T3-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 " HMA Anterior Spinal Stabilization 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, lordosis, whether neuromuscular or related to deficient posterior elements) - Tumors (neoplastic disease) - Pseudarthrosis - Failed previous fusion surgery

Device Story

Anterior spinal stabilization system; consists of implantable metallic plates, rods, clamps, locking nuts, and HMA polyaxial/monoaxial screws. Used during anterior spinal fusion surgery to provide stabilization to thoracic and lumbar spine (T3-L5). Components form construct via screw fixation to anterolateral vertebral bodies. Operated by surgeons in clinical setting. Provides mechanical support to facilitate solid spinal fusion. Benefits patients by stabilizing spine in presence of degenerative disease, deformity, or trauma.

Clinical Evidence

Bench testing only. Fatigue testing of worst-case system configuration performed on titanium constructs. No clinical data provided.

Technological Characteristics

Constructs made of titanium. Components include plates, rods, clamps, locking nuts, and polyaxial/monoaxial screws. Conforms to applicable ASTM and ISO standards. Mechanical fixation system; no software or energy source.

Indications for Use

Indicated for patients with degenerative disk disease, spondylolisthesis, spondylolysis, fractures, spinal stenosis, deformities (scoliosis, kyphosis, lordosis), tumors, pseudarthrosis, or failed previous fusion surgery requiring stabilization of the thoracic and lumbar spine (T3-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

• K-Centrum Anterior Spinal Fixation System (K990959, K002371)

Reference Devices

• MACS modular anterior construct system (K002824)

Submission Summary (Full Text)

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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

In Accordance with SMDA of 1990

NOV 1 6 2001

# MACS™ HMA Anterior Spinal Stabilization System

May 16, 2001

| COMPANY: | Aesculap ®, Inc.<br>3773 Corporate Parkway<br>Center Valley, PA 18034 |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Lisa M. Millington, Regulatory Associate<br>800-258-1946 (phone)<br>610-231-3713 (fax)<br>[e-mail] (email) |
| TRADE NAME: | MACSTL HMA Anterior Spinal Stabilization System |
| COMMON NAME: | Anterior-Lateral Spinal Stabilization System |
| DEVICE CLASS: | Class II |
| PRODUCT CODE: | KWQ |
| CLASSIFICATION: | 888.3060 – Spinal intervertebral body fixation orthosis |
| REVIEW PANEL: | Orthopedic and Rehabilitation Devices Panel |

# 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 (T3-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 " HMA Anterior Spinal Stabilization 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, lordosis, whether . neuromuscular or related to deficient posterior elements)
- . Tumors (neoplastic disease)
- Pseudarthrosis
- Failed previous fusion surgery ●

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# DEVICE DESCRIPTION

K011556

The MACS 1 HMA Anterior Spinal Stabilization System includes implantable metallic plates, rods, clamps, locking nuts and screws. The components are used in various combinations to form a construct for use during anterior spinal fusion surgery. The MACS" modular anterior construct system (K002824), which was cleared on May 8, 2001, consists of the twin screws, where as the MAC™ HMA Anterior Spinal Stabilization System consists of the HMA Polyaxial and Monoaxial Screws. Both of these systems are considered a part of each other. The stabilization plates, connection rods, fixation nut, locking screw, bone graft clamp and screw have been cleared under the MACS" modular anterior construct system (K002824).

### 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.

Fatigue testing of a "worst case" system configuration was conducted on samples of constructs made of titanium. A summary of this testing can be found in Section IV and the final reports are provided in Appendix I.

## SUBSTANTIAL EQUIVALENCE

MACS" HMA Anterior Spinal Stabilization System is substantially equivalent in their intended use, design, and basic operating principles to the following predicate devices:

K-Centrum Anterior Spinal Fixation System .

By The Spineology Group (#K990959 & K002371) The K-Centrum® - Anterior Spinal Fixation System is cleared for marketing. K-Centrum® is an anterior spinal construct made up of one rod connected to two cage-like vertebral body screws. This system was tested using ASTM F-1717-96 recommendations. Properties of stiffness. strength and fatique life were determined. The K-Centrum® is intended to be used for the surgical treatment of vertebral body fractures and tumors. Equivalence can be seen in the design, material composition, surgical technique, testing methodologies and intended use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 6 2001

Ms. Lisa M. Millington Regulatory Associate Aesculap®. Inc. 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: KOI 1556 Trade/Device Name: MACST HMA Anterior Spinal Stabilization System Regulatory Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Fixation Orthosis Regulatory Class: II Product Code: KWQ Dated: August 24, 2001 Received: August 29, 2001

Dear Ms. Millington:

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 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 (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.

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Page 2 - Ms. Lisa M. Millington

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

**Sincerely yours,**

Colie M. Witter, 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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# NOV 1 6 2001

# INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Kollste

Device Name: MACS™ HMA Anterior Spinal Stabilization 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 (T3-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 " HMA Anterior Spinal Stabilization 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
- . Spondvlolisthesis
- . Spondvlolysis
- Fracture ●
- Spinal stenosis .
- Deformities (i.e., scoliosis, kyphosis, lordosis, whether neuromuscular or . related to deficient posterior elements)
- Tumors (neoplastic disease) ●
- Pseudarthrosis ●
- Failed previous fusion surgery .

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (6

for
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number K011556
Prescription Use X or Over-the-Counter Use
(per 21 CFR 801.109) (Optional Format 3-10-98)