DENALI DEFORMITY SYSTEM

K052404 · K2m, LLC · KWP · May 23, 2006 · Orthopedic

Device Facts

• Record ID: K052404
• Device Name: DENALI DEFORMITY SYSTEM
• Applicant: K2m, LLC
• Product Code: KWP · Orthopedic
• Decision Date: May 23, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Denali Deformity System is a non-cervical spinal fixation device intended for posterior, non-pedicle 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); spinal stenosis; curvatures (i.e. scoliosis; and/or lordosis);tumor; pseudoarthrosis; and failed previous fusion. The Denali Deformity System is also intended for non-cervical pedicle screw fixation for the following indications: trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis; tumor, pseudoarthrosis; and failed previous fusion. It is also indicated for the treatment of severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

Device Story

Top-loading, posterior spinal fixation system; components include pedicle screws, rods, locking set screws, offset connectors, and transverse connectors. Used as adjunct to fusion to immobilize thoracic, lumbar, or sacral spinal segments. Surgeon-operated in clinical/OR setting. Provides mechanical stabilization to facilitate bone fusion; components sized to match patient anatomy. Output is physical immobilization of spinal segments; clinical decision-making based on patient spinal pathology and need for fusion support.

Clinical Evidence

Bench testing only. Biomechanical testing performed per ASTM F1717 compared the Denali Deformity System to predicate systems. Results indicated performance equal to or better than the predicate devices.

Technological Characteristics

Top-loading posterior spinal fixation system. Materials: Ti6Al-4V ELI alloy per ASTM and ISO standards. Components: pedicle screws, rods, locking set screws, offset/transverse connectors. Mechanical fixation principle. No software or energy source.

Indications for Use

Indicated for patients requiring non-cervical spinal fixation for degenerative disc disease, spondylolisthesis, trauma (fracture/dislocation), spinal stenosis, scoliosis, lordosis, kyphosis, tumor, pseudoarthrosis, or failed fusion. Severe spondylolisthesis (grades 3-4) at L5-S1 requires skeletally mature patients receiving autogenous bone graft fusion with implants attached L3-sacrum.

Regulatory Classification

Identification

A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.

Predicate Devices

• Xia Spine System (Stryker Howmedica Osteonics)
• Denali Spine System (K2M, LLC)
• CD Horizon Legacy 5.5mm Spinal System (Medtronic Sofamor Danek)

Submission Summary (Full Text)

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K052404
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### 510(k) Summary for the Denali Deformity System

This safety and effectiveness summary for the Deformity System is provided as required per Section 513(i)(3) of the Food, Drug and Cosmetic Act.

#### 1. Submitter :

K2M, LLC 751 Miller Drive, SE Suite F1 Leesburg, VA 20175

Date Prepared: August 29, 2005 Contact Person : Richard W. Woods K2M, LLC 751 Miller Drive, SE, Suite F1 MAY 2 3 2006 Leesburg, VA 20175 Telephone: [phone]

MAY 23 2006

| 2. Tradename: | Denali Deformity Spinal System |
|----------------------|-----------------------------------------------------------------------------------------------------------------|
| Common Name: | Spine Fixation System |
| Classification Name: | Pedicle Screw Spinal System (21 CFR 888.3070(b)(1) )<br>Spinal Interlaminal Fixation Orthosis (21 CFR 888.3050) |

## 3. Predicate or legally marketed devices which are substantially equivalent:

- Xia Spine System ( Stryker Howmedica Osteonics ) ●
- Denali Spine System ( K2M, LLC ) .
- CD Horizon Legacy 5.5mm Spinal System (Medtronic Sofamor Danek) .

#### 4. Description of the device:

The Denali Deformity System is a top-loading, multiple component, posterior spinal fixation system which consists of pedicle screws, rods, locking set screws, offset connectors and transverse connectors. All of the components are available in a variety of sizes to match more closely the patient's anatomy.

Materials: The devices are manufactured from Ti6Al-4V ELI alloy per ASTM and ISO standards.

Function: The system functions as an adjunct to fusion to provide immobilization of spinal segments of the thoracic, lumbar or sacral spine.

#### 5. Intended Use:

The Denali Deformity System is a non-cervical spinal fixation device intended for posterior, non-pedicle 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); spinal stenosis; curvatures (i.e. scoliosis; and/or lordosis);tumor; pseudoarthrosis; and failed previous fusion.

The Denali Deformity System is also intended for non-cervical pedicle screw fixation for the following indications: trauma (i.e. fracture or dislocation); spinal stenosis; curvatures (i.e. scoliosis, kyphosis; tumor, pseudoarthrosis; and failed previous fusion. It is also indicated for the treatment of severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

# 6. Comparison of the technological characteristics of the device to predicate and legally marketed devices :

The Denali Deformity System was biomechanically tested and compared to the predicate systems and other currently marketed systems and performed equal to or better than these systems in ASTM testing to F1717. The design features and sizing of the components were also compared and the Denali Deformity System found to be substantially the same as these systems. It is manufactured from the same FDA recognized materials and is indicated for the same intended uses as these systems. There are no significant differences between the Denali Deformity Spinal System and other systems currently being marketed which would adversely affect the use of the product. It is substantially equivalent to these other devices in design, function, material and intended use.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" arranged in a circular fashion around the symbol. The logo is black and white.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAY 2 3 2006

K2M, L.L.C. c/o Mr. Richard W. Woods Senior Vice President 751 Miller Dr., SE, Suite F-1 Leesburg, Virginia 20175

Re: K052404

Trade/Device Name: Denali Deformity System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle Screw Spinal System Regulatory Class: Class II Product Code: MNI, MNH, KWP Dated: April 24, 2006 Received: April 26, 2006

Dear Mr. Woods:

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. Ilsting 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. Richard W. Woods

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" (21 CFR 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,

Herbert Lenner us

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health h

Enclosure

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# Indications for Use

510(k) Number (if known):

Device Name: Denali Deformity System

Indications for Use:

The Denali Deformity System is a non-cervical spinal fixation device intended for posterior, non-pedicle 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 ); spinal stenosis; curvatures ( i.e. scoliosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

The Denali Deformity System is also intended for non-cervical pedicle screw fixation for the following indications: trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures ( i.e. scoliosis, kyphosis; and/or lordosis); turnor; pseudoarthrosis; and failed previous fusion. It is also indicated for the treatment of severe spondylolisthesis ( grades 3 and 4 ) of the LS-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine ( L3 to sacrum ) with removal of the implants after the attainment of a solid 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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hubert Lerner us

Division of General, Restorative, and Neurological Devices

**510(k) Number** K052464