THORACOLUMBAR PLATE, MODEL 1208-41FXX, LUMBER PLATE, MODEL 1208-41FXXL, SACRAL PLATE, MODEL 1208-41FXXS

K091253 · K2m, Inc. · KWQ · Jun 4, 2009 · Orthopedic

Device Facts

• Record ID: K091253
• Device Name: THORACOLUMBAR PLATE, MODEL 1208-41FXX, LUMBER PLATE, MODEL 1208-41FXXL, SACRAL PLATE, MODEL 1208-41FXXS
• Applicant: K2m, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Jun 4, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cayman Thoracolumbar Plate System is indicated for use via the lateral or anterolateral surgical approach in the treatment of thoracolumbar (T1-L5) spine and for use as an anteriorly placed supplemental fixation device for the lumbosacral level below the bifurcation of the vascular structures (L1-S1). The Cayman Thoracolumbar Plate System is intended to provide temporary stabilization during fusion using autograft or allograft in skeletally mature patients in the following acute and chronic instabilities and deformities: a) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), b) pseudoarthrosis, c) spondylolysis, d) spondylolisthesis, e) fracture, f) neoplastic disease, g) unsuccessful previous fusion surgery, h) lordotic deformities of the spine, i) thoracolumbar or lumbar scoliosis, j) deformity (i.e., scoliosis, kyphosis, and/or lordosis) associated with deficient posterior elements such as that resulting from laminectomy.

Device Story

Spinal fixation system comprising plates and screws; provides temporary immobilization/stabilization of spine as adjunct to fusion. Used in lateral or anterolateral surgical approaches; implanted by surgeons. Components available in various sizes to match patient anatomy. Benefits patient by stabilizing spine during healing of acute/chronic instabilities or deformities. No software or automated processing involved.

Clinical Evidence

Bench testing only. Static compression, dynamic compression, and static torsion testing performed in accordance with ASTM F1717.

Technological Characteristics

Materials: CP Titanium and Ti6Al4V per ASTM and ISO standards. Components: Plates and screws in various sizes. Mechanical testing: ASTM F1717 (static/dynamic compression, static torsion). No software or electronic components.

Indications for Use

Indicated for skeletally mature patients requiring temporary spinal stabilization during fusion (autograft/allograft) via lateral or anterolateral approach. Treats T1-L5 thoracolumbar spine and L1-S1 lumbosacral levels. Conditions: degenerative disc disease, pseudoarthrosis, spondylolysis, spondylolisthesis, fracture, neoplastic disease, failed fusion, lordotic deformities, scoliosis, and deformities associated with deficient posterior elements.

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

• K2M Cayman Thoracolumbar Plate System (K081380)
• Blackstone Medical Unity Anterior Lumbar Plate Fixation System (K043548)
• Synthes Thoracolumbar Spine Locking Plate (K020244)
• Medtronic Sofamor Danek Pyramid Anterior Plate Fixation System (K013665)
• Sofamor Danek Z-Plate (K922543)
• Stryker Thor Anterior Plating System (K080773)
• Theken BodyForm Thoracic Fixation System (K072407)

Submission Summary (Full Text)

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JUN - 4.2009

KU91253

# 510(k) SUMMARY

for the

#### Cayman Thoracolumbar Plate System, Additional Sizes

This safety and effectiveness summary for the Cayman Thoracolumbar Plate System is provided as required per Section 513(Y(3) of the Food. Drug and Cosmetic Act.

| 1. Submitter : | Contact Person : |
|---------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| K2M, Inc.<br>751 Miller Drive SE,<br>Suite F1<br>Leesburg, VA 20175 | Richard W. Woods<br>K2M, Inc.<br>751 Miller Drive SE, Suite F1<br>Leesburg, VA 20175<br>Telephone: [phone] |
| Date Prepared: | April 28, 2009 |

| 2. Tradename: | Cayman Thoracolumbar Plate System |
|----------------------|----------------------------------------------------------------|
| Common Name: | Thoracolumbar Plates |
| Classification Name: | Spinal intervertebral body fixation orthosis (21 CFR 888.3060) |

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

- K2M Cayman Thoracolumbar Plate System, K081380 .
- Blackstone Medical Unity Anterior Lumbar Plate Fixation System, K043548 .
- Synthes Thoracolumbar Spine Locking Plate. K020244 ◆
- Medtronic Sofamor Danek Pyramid Anterior Plate Fixation System, K013665 .
- Sofamor Danek Z-Plate, K922543 .
- Stryker Thor Anterior Plating System, K080773 .
- Theken BodyForm Thoracic Fixation System, K072407 .

#### 4. Description of the device:

The Cayman Thoracolumbar Plate System is a spinal fixation system which consists of screws and plates. 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 CP Titanium and Ti6Al4V per ASTM and ISO standards.

Function: The system functions as an adjunct to fusion to provide immobilization of the spine.

#### 5. Intended Use:

The Cayman Thoracolumbar Plate System is indicated for use via the lateral or anterolateral surgical approach in the treatment of thoracolumbar (T1-L5) spine and for use as an anteriorly placed supplemental fixation device for the lumbosacral level below the bifurcation of the vascular structures (LI-\$1). The Cayman Thoracolumbar Plate System is intended to provide temporary stabilization during fusion using autograft or allograft in skeletally mature patients in the following acute and chronic instabilities and deformities: a) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), b) pseudoarthrosis, c) spondylolysis, d) spondylolisthesis, e) fracture, f) neoplastic disease, g) unsuccessful previous fusion surgery, h) lordotic deformities of the spine, i) thoracolumbar or lumbar scoliosis, j) deformity (i.e., scoliosis, kyphosis, and/or lordosis) associated with deficient posterior elements such as that resulting from laminectomy.

#### 6. Technological and Performance Characteristics:

The Cayman Thoracolumbar Plates were tested in static compression bending, dynamic compression testing and static torsion in accordance with ASTM F1717 and are considered substantially equivalent to other legally marketed devices. They are similar in design, material, and indications for use and are expected to be equivalent in safety and effectiveness.

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Image /page/1/Picture/0 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. The bottom half of the circle contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". In the center of the circle is an image of an eagle.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

K2M, Inc. % Mr. Richard W. Woods 751 Miller Drive, S.E. Suite F1 Leesburg, Virginia 20175

JUN - 4 2009

Re: K091253

Trade/Device Name: Cayman Thoracolumbar Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWO Dated: April 28, 2009 Received: May 5, 2009

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, 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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Mark N. Milliman

Mark N. Melkerson Director Division of Surgical. Orthopedic. and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

## 510(k) Number (if known): K091253

Device Name: Cayman Thoracolumbar Plate System

#### Indications for Use:

The Cayman Thoracolumbar Plate System is indicated for use via the lateral or anterolateral surgical approach in the treatment of thoracolumbar (T1-L5) spine and for use as an anteriorly placed supplemental fixation device for the lumbosacral level below the bifurcation of the vascular structures (L1-S1). The Cayman Thoracolumbar Plate System is intended to provide temporary stabilization during fusion using autograft or allograft in skeletally mature patients in the following acute and chronic instabilities and deformities: a) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), b) pseudoarthrosis, c) spondylolysis, d) spondylolisthesis, e) fracture, f) neoplastic disease, g) unsuccessful previous fusion surgery, h) lordotic deformities of the spine, i) thoracolumbar or lumbar scoliosis, i) deformity (i.e., scoliosis, kyphosis, and/or lordosis) associated with deficient posterior elements such as that resulting from laminectomy.

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)

Sof (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number.

K091253