CAYMAN SCREWS MODEL K2-12-1000-XX, K2-12-1001-XX

K100061 · K2m, Inc. · KWQ · Feb 12, 2010 · Orthopedic

Device Facts

• Record ID: K100061
• Device Name: CAYMAN SCREWS MODEL K2-12-1000-XX, K2-12-1001-XX
• Applicant: K2m, Inc.
• Product Code: KWQ · Orthopedic
• Decision Date: Feb 12, 2010
• 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, i) deformity (i.e., scoliosis, kyphosis, and/or lordosis) associated with deficient posterior elements such as that resulting from laminectomy.

Device Story

Spinal fixation system consisting of plates and screws; provides temporary stabilization as adjunct to fusion. Used in lateral or anterolateral surgical approaches to thoracolumbar spine or anteriorly for lumbosacral levels. Operated by surgeons in clinical/OR settings. Components available in various sizes to match patient anatomy. System immobilizes spine to facilitate fusion in patients with acute/chronic instabilities or deformities. Benefits include structural support during healing process.

Clinical Evidence

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

Technological Characteristics

Materials: CP Titanium and Ti6Al4V per ASTM and ISO standards. Mechanical testing: ASTM F1717 (static compression, dynamic compression, static torsion). Form factor: Plates and screws in various sizes for spinal fixation.

Indications for Use

Indicated for skeletally mature patients requiring temporary spinal stabilization during fusion (autograft/allograft) via lateral or anterolateral approach (T1-L5) or anterior lumbosacral fixation (L1-S1). Treats degenerative disc disease, pseudoarthrosis, spondylolysis, spondylolisthesis, fracture, neoplastic disease, failed fusion, and spinal deformities (scoliosis, kyphosis, lordosis).

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)
• DePuy Kaneda SR (K971248)
• Synthes VentroFix (K031100)
• Globus Medical Gateway (K062407)
• Medtronic Sofamor Danek Z-Plate II (K922543)

Submission Summary (Full Text)

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K100061 Page 1

510(k) SUMMARY for the

FEB 1 2 2010

# Cayman Thoracolumbar Plate System, Longer Screws

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

| 1. Submitter : | | Contact Person : |
|----------------------|------------------|-------------------------------|
| K2M, Inc. | | Nancy Giezen |
| 751 Miller Drive SE, | | K2M, Inc. |
| Suite F1 | | 751 Miller Drive SE, Suite F1 |
| Leesburg, VA 20175 | | Leesburg, VA 20175 |
| | | Telephone: [phone] |
| Date Prepared: | January 08, 2010 | |

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

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

- K2M Cayman Thoracolumbar Plate System, K081380 .
- . DePuy Kaneda SR, K971248
- Synthes VentroFix, K031100 ●
- Globus Medical Gateway, K062407 .
- ◆ Medtronic Sofamor Danek Z-Plate II, K922543

## 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 Ti6A14V 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 (TI-L5) spine and for use as an anteriorly placed supplemental fixation device for the lumbosacral level below the bifurcation of the vascular structures (LI-SI). 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.

## 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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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized caduceus, which is a symbol often associated with healthcare and medicine. The caduceus is depicted with a staff entwined by a serpent and topped with wings.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

K2M, Inc. % Nancy Giezen Manager, Regulatory Affairs 751 Miller Drive, S.E., Suite F1 Leesburg, VA 20175

FEB 1 2 2010

Re: K100061

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: KWQ Dated: January 8, 2010 Received: January 12, 2010

Dear Ms. Giezen:

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 for association 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). and oosmetire fore, market the device, subject to the general controls provisions of the Act. The I va mayy ators provisions of the Act include requirements for annual registration, listing of general controll proficituring practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it 11 your artise 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 r road be action and a determination that your device complies with other requirements of the Act that I Drivias intacted and regulations administered by other Federal agencies. You must or any 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

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Page 2 – Ms. Nancy Giezen

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.

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/MedicalDevices/Safety/ReportalProblem/default.htm 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,
Mark A. Milliken

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): K| 0006 |

Device Name: Cayman Thoracolumbar Plate System

Indications for Use:

The CAYMAN THORACOLUMBAR PLATES are 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 autograph or allograft in skeletally mature patients in the treatment of 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.

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)

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

210(k) Number_K10006 I