AEGIS ANTERIOR LUMBAR PLATE SYSTEM

K052546 · Depuy Spine, Inc. · KWQ · Feb 3, 2006 · Orthopedic

Device Facts

• Record ID: K052546
• Device Name: AEGIS ANTERIOR LUMBAR PLATE SYSTEM
• Applicant: Depuy Spine, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Feb 3, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The AEGIS Anterior Lumbar Plate System is indicated for use as an anteriorly placed supplemental fixation device via the lateral or anterolateral surgical approach above the bifurcation of the great vessel or via the anterior surgical approach, below the bifurcation of the great vessels. The device is intended as a temporary fixation device until fusion is achieved. The AEGIS Anterior Lumbar Plate System is intended for anterior lumbar (L1 - S1) fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

Device Story

AEGIS Anterior Lumbar Plate System consists of titanium alloy plates and screws; used as supplemental fixation device for anterior lumbar (L1-S1) spine. Implanted by surgeons via lateral, anterolateral, or anterior surgical approaches. Provides temporary stabilization to facilitate spinal fusion. Device remains in situ until fusion is achieved. No software or electronic components.

Clinical Evidence

Bench testing only.

Technological Characteristics

Materials: ASTM F-136 implant grade titanium alloy. Form factor: Plates and screws. Energy source: None (mechanical). Sterilization: Not specified. Connectivity: None. Software: None.

Indications for Use

Indicated for patients requiring anterior lumbar (L1-S1) supplemental fixation for degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), deformities (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or failed previous fusion. Used as temporary fixation until fusion is achieved.

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

• DePuy AcroMed M-2 Anterior Plate System (K972718)
• Medtronic Sofamor Danek PYRAMID Anterior Plate Fixation System (K013665)

Submission Summary (Full Text)

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## AEGIS Anterior Lumbar Plate System

#### 510(k) Summary IX.

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SUBMITTER: DePuy Spine, Inc. 325 Paramount Drive Raynham, MA 02780

- CONTACT PERSON: Mary Gray Phone: [phone] Fax: [phone]
- DATE PREPARED: January 12, 2006
- CLASSIFICATION NAME: Spinal Intervertebral Body Fixation Orthosis 8888.3060
- AEGIS Anterior Lumbar Plate System PROPRIETARY NAME:
- DePuy AcroMed M-2 Anterior Plate System, K972718 PREDICATE DEVICES: Medtronic Sofamor Danek PYRAMID Anterior Plate Fixation System, K013665
- DEVICE DESCRIPTION: The AEGIS Anterior Lumbar Plate System consists of an assortment of plates and screws.

The AEGIS Anterior Lumbar Plate System also contains Class 1 manual surgical instruments and cases that are considered exempt from premarket notification.

- INTENDED USE: The indications for use for the devices described in this submission are as follows:
The AEGIS Anterior Lumbar Plate System is indicated for use as an anteriorly placed supplemental fixation device via the lateral or anterolateral surgical approach above the bifurcation of the great vessel or via the anterior surgical approach, below the bifurcation of the great vessels.

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### AEGIS Anterior Lumbar Plate System

The device is intended as a temporary fixation device until fusion is achieved. The AEGIS Anterior Lumbar Plate System is intended for anterior lumbar (L1 - S1) fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

| MATERIALS: | Manufactured from ASTM F-136 implant grade titanium alloy. |
|------------|------------------------------------------------------------|
|------------|------------------------------------------------------------|

PERFORMANCE DATA:

Performance data were submitted to characterize the AEGIS Anterior Lumbar Plate System components.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling a stylized emblem. The emblem consists of a triple-line design, resembling a stylized human form, which is a common symbol associated with HHS.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 3 2006

Ms. Mary Gray Senior Regulatory Affairs Associate Depuy Spine 325 Paramount Drive Raynham, MA 02767

Re: K052546

Trade Name: AEGIS Anterior Lumbar Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation System Regulatory Class: II Product Code: KWQ Dated: January 12, 2006 Received: January 13, 2006

Dear Ms. Gray:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have letermined 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 accordailed with the provisions of the Pourmay, therefore, market the device, subject to approval of a provisions of the Act. The general controls provisions of the Act include the general construction, 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 rryour do nec 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 I oter a 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. Noah Bartsch

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/industry/support/index.html.

Sincerely yours,

A Mark N. Melkerson 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

510(k) Number (if known): K052546

AEGIS Anterior Lumbar Plate System Device Name:

Indications For Use:

The AEGIS Anterior Lumbar Plate System is indicated for use as an anteriorly placed supplemental fixation device via the lateral or anterolateral surgical approach above the bifurcation of the great vessel or via the anterior surgical approach, below the bifurcation of the great vessels.

The device is intended as a temporary fixation device until fusion is achieved . The AEGIS Anterior Lumbar Plate System is intended for anterior lumbar (1.1 - S1) fixation for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with dcgcneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEIEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

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**510(k) Number** K052546