CASPIAN SPINAL SYSTEM

K092640 · K2m, Inc. · MNI · Nov 6, 2009 · Orthopedic

Device Facts

• Record ID: K092640
• Device Name: CASPIAN SPINAL SYSTEM
• Applicant: K2m, Inc.
• Product Code: MNI · Orthopedic
• Decision Date: Nov 6, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Caspian Spinal System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies) Spondylolisthesis Spinal stenosis Fracture/dislocation Revision of previous cervical spine surgery Tumors The implants are intended to provide stabilization as an adjunct to fusion when used with autogenous bone graft or allograft following the reduction of fractures/dislocations or trauma in the spine. The rod and hook components are intended for use in the cervical/upper thoracic (C1-T3) spine. The pedicle screws are limited to placement in T1-T3 in treating thoracic conditions only. The pedicle screws are not intended to be placed in or treat conditions involving the cervical spine. The Caspian Spinal System can also be linked to the Range Spinal System using the 3.5mm rod connectors or transitional rods.

Device Story

Caspian Spinal System is a top-loading, posterior cervical-thoracic spinal fixation system. Components include pedicle screws, rods, locking set screws, hooks, and rod connectors. System provides immobilization and stabilization of spinal segments as an adjunct to fusion. Used by surgeons in clinical settings to treat spinal pathologies including DDD, spondylolisthesis, stenosis, fractures, and tumors. Can be linked to Range Spinal System via connectors. Benefits include spinal stabilization following trauma or surgical intervention.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Top-loading posterior spinal fixation system. Materials: Ti6Al4V Eli and Cobalt Chrome per ASTM and ISO standards. Components: pedicle screws, rods, locking set screws, hooks, rod connectors. Connectivity: mechanical linkage to Range Spinal System.

Indications for Use

Indicated for patients with DDD (discogenic neck pain), spondylolisthesis, spinal stenosis, fracture/dislocation, tumors, or requiring revision of previous cervical spine surgery. Rods/hooks for C1-T3; pedicle screws for T1-T3 thoracic conditions only (not for cervical spine). Used as adjunct to fusion with autogenous bone graft or allograft.

Regulatory Classification

Identification

(1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.

Special Controls

*Classification.* (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards; (ii) Compliance with mechanical testing standards; (iii) Compliance with biocompatibility standards; and (iv) Labeling that contains these two statements in addition to other appropriate labeling information: “Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.” “Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.” (2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls: (i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use. (ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant. (iii) Device components must be demonstrated to be biocompatible. (iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments. (v) Labeling must include the following: (A) A clear description of the technological features of the device including identification of device materials and the principles of device operation; (B) Intended use and indications for use, including levels of fixation; (C) Identification of magnetic resonance (MR) compatibility status; (D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and (E) Detailed instructions of each surgical step, including device removal. (3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls: (i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate. (ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.

Predicate Devices

• Synthes Starlock/ Cervifix
• DePuy Mountaineer
• K2M Caspian Spinal System

Reference Devices

• Range Spinal System

Submission Summary (Full Text)

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## 510(k) Summary for the Caspian Spinal System

NOV - 6 2009

This 510(k) summary for the Caspian Spinal System is provided as required per Section 513(i)(3) of the Food, Drug and Cosmetic Act.

- 1. Submitter : K2M. Inc. 751 Miller Drive SE.
Suite F1 Leesburg, VA 20175

Date Prepared: 08/26/09

Contact Person :

Richard W. Woods K2M, Inc. 751 Miller Drive SE, Suite Fl Leesburg, VA 20175 Telephone: [phone]

| 2. Tradename: | Caspian Spinal System |
|----------------------|--------------------------------------------------------|
| Common Name: | Spinal Fixation System |
| Classification Name: | Spinal Interlaminal Fixation Orthosis (21CFR 888.3050) |
| Device Product Code: | KWP |
| Regulatory Class: | Class II |

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

- . Synthes Starlock/ Cervifix
- . DePuy Mountaineer
- . K2M Caspian Spinal System

#### 4. Description of the device:

The Caspian Spinal System is a top-loading, multiple component, posterior (cervical-thoracic) spinal fixation system which consists of pedicle screws, rods, locking set screws, hooks, and rod connectors.

Materials: The devices are manufactured from Ti6Al4V Eli and Cobalt Chrome per ASTM and ISO standards.

Function: The system functions as an adjunct to fusion to provide immobilization and stabilization of spinal segments of the cervical and thoracic (T1-T3) spine.

#### 5. Intended Use:

The Caspian Spinal System is indicated for the following:

- DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and . radiographic studies)
- . Spondylolisthesis
- . Spinal stenosis
- . Fracture/dislocation
- Revision of previous cervical spine surgery
- . Tumors

The implants are intended to provide stabilization as an adjunct to fusion when used with autogenous bone graft or allograft following the reduction of fractures/dislocations or trauma in the spine.

The rod and hook components are intended for use in the cervical/upper thoracic (C1-T3) spine. The pedicle screws are limited to placement in T1-T3 in treating thoracic conditions only. The pedicle screws are not intended to be placed in or treat conditions involving the cervical spine.

The Caspian Spinal System can also be linked to the Range Spinal System using the 3.5mm rod connectors or transitional rods.

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K092640 Rgez

- 6. Comparison of the technological characteristics of the device to predicate and legally marketed devices : The Caspian Spinal System is 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/2/Picture/0 description: The image contains the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle or bird-like figure with outstretched wings. The emblem is black and white and has a simple, graphic design.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

K2M, Inc. % Mr. Richard W. Woods Senior V.P. of Engineering 751 Miller Drive SE, Suite F-1 Leesburg, Virginia 20175

NOV - 6 2009

Re: K092640

Trade/Device Name: Caspian Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Code: MNI, KWP Dated: October 8, 2009 Received: October 13, 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/MedicalDevices/Safety/ReportaProblem/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Sincerely yours,

Mark A. Milam

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(092640

Device Name: Caspian Spinal System

. Indications for Use:

The Caspian Spinal System is indicated for the following:

- DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history . and radiographic studies)
- Spondylolisthesis .
- . Spinal stenosis
- . Fracture/dislocation
- Revision of previous cervical spine surgery .
- . Tumors

The implants are intended to provide stabilization as an adjunct to fusion when used with autogenous bone graft or allograft following the reduction of fractures/dislocations or trauma in the spine.

The rod and hook components are intended for use in the cervical/upper thoracic (C1-T3) spine. The pedicle screws are limited to placement in T1-T3 in treating thoracic conditions only. The pedicle screws are not intended to be placed in or treat conditions involving the cervical spine.

The Caspian Spinal System can also be linked to the Range Spinal System using the 3.5mm rod connectors or transitional rods.

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

K092640 510(k) Number_