EVEREST SPINAL SYSTEM

K120656 · K2m, Inc. · MNI · Apr 4, 2012 · Orthopedic

Device Facts

• Record ID: K120656
• Device Name: EVEREST SPINAL SYSTEM
• Applicant: K2m, Inc.
• Product Code: MNI · Orthopedic
• Decision Date: Apr 4, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Everest Spinal System if used in conjunction with the Range (Mesa and Denali) Spinal Systems are: Non-cervical, pedicle screw fixation devices for posterior stabilization as an adjunct to fusion for the following indications: Trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures (i.e. scoliosis, kyphosis; and/or lordosis); 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. Non-cervical, non-pedicle spinal fixation devices intended for posterior or anterolateral thoracolumbar screw stabilization as an adjunct to fusion 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, kyphosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

Device Story

Everest Spinal System is a top-loading, posterior thoracic-lumbar spinal fixation system; components include pedicle screws, rods, locking set screws, and hooks. Device functions as an adjunct to spinal fusion to provide immobilization. Used by surgeons in clinical settings. System expansion adds screw sizes and connectors for compatibility with Range Spinal System components. Provides mechanical stabilization to the spine to facilitate fusion; implants are intended for removal after solid fusion is achieved in specific spondylolisthesis cases.

Clinical Evidence

Bench testing only. Mechanical testing performed in accordance with ASTM F1717, including static compression, static torsion, and dynamic compression, to compare modified Everest Spinal System constructs against predicate devices.

Technological Characteristics

Top-loading posterior spinal fixation system. Materials: Titanium Alloy and Chrome per ASTM and ISO standards. Components: pedicle screws, rods, locking set screws, hooks. Connectivity: None. Energy source: None (mechanical).

Indications for Use

Indicated for skeletally mature patients requiring posterior or anterolateral thoracolumbar stabilization as an adjunct to fusion. Conditions include trauma (fracture/dislocation), spinal stenosis, scoliosis, kyphosis, lordosis, tumor, pseudoarthrosis, failed previous fusion, and degenerative disc disease. Severe spondylolisthesis (grades 3-4) at L5-S1 specifically indicated for pedicle screw fixation (L3-sacrum) with autogenous bone graft.

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

• K2M Everest Spinal System (K081107)
• K2M Range Spinal System (K070229, K072914, K080792, K081381, K100851, K112037, K112920)
• K2M Caspian Spinal System (K081107, K092540, K093534, K103232, K113654)
• DePuy Mountaineer (K110353)

Submission Summary (Full Text)

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K120656'

APR - 4 2012

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

This 510(k) summary for the Everest Spinal System is provided as reguired 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 Contact Person : Nancy Giezen K2M, Inc. Telephone: [phone]

Date Prepared: 03/02/12

2. Tradename: Common Name: Classification Name:

Device Product Code: Regulatory Class:

Everest Spinal System Spinal Fixation System Spinal Interlaminal Fixation Orthosis (21CFR 888.3050), Pedicle screw spinal system (21CFR 888.3070). KWP, MNI, MNH Class II

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

- K2M Everest Spinal System (K081107) .
- K2M Range Spinal System (K070229, K072914, K080792, K081381, K100851, K112037, K112920) .
- . K2M Caspian Spinal System (K081107, K092540, K093534, K103232, K113654)
- DePuy Mountaineer (K110353 .

#### 4. Description of the device:

The Everest Spinal System is a top-loading, multiple component, posterior (thoracic-lumba) spinal fixation system which consists of pedicle screws, rods, locking set screws, and hooks. The purpose of this submission is to increase the range of screw sizes and to add connectors to enable use with Range Spinal System conponents.

Materials: The devices are manufactured from Titanium Alloy and Chrome per ASTM and ISO standards.

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

#### 5. Intended Use:

The Everest Spinal System if used in conjunction with the Range (Mesa and Denali) Spinal Systems are:

Non-cervical, pedicle screw fixation devices for posterior stabilization as an adjunct to fusion for the following indications: Trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures (i.e. scoliosis, kyphosis; and/or lordosis); 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.

Non-cervical, non-pedicle spinal fixation devices intended for posterior or anterolateral thoracolumbar screw stabilization as an adjunct to fusion for the following indications: degenerative disc disease (DDD ) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and

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K120656

radiographic studies ); spondylolisthesis; trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures ( i.e. scoliosis, kyphosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

- 6. Comparison of the technological characteristics of the device to predicate and legally marketed devices : Proposed components of the Everest Spinal System were tested and compared to predicate devices. The modified Everest Spinal System constructs performed equally to or better than the predicates in static compression, static torsion and dynamic compression in accordance with ASTM F1717. The design features and sizing of the components were also compared and the Everest Spinal System was found to be substantially the same as these systems.
#### 7. Conclusion:

There are no significant differences between the Everest 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/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). 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 abstract symbol that resembles an eagle or bird in flight, composed of three stylized, curved lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

K2M. Incorporated % Ms. Nancy Giezen Manager, Regulatory Affairs 751 Miller Drive Southeast, Suite F1 Leesburg, Virginia 20175

APR - 4 2012

Re: K120656

Trade/Device Name: Everest Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI, MNH, KWP Dated: March 02, 2012 Received: March 05, 2012

## 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 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. 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 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 that I Drederal statutes and regulations administered by other Federal agencies. You must or uny I 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 de rece related daverse overals) (1 CFR Part 820); and if applicable, the electronic form in the quant) 2) router (Sections 531-542 of the Act); 21 CFR 1000-1050.

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# Page 2 - Ms. Nancy Giezen

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please i 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,
Erin L. Keith

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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K120656

# Indications for Use

K120656 510(k) Number (if known):

Device Name: Everest Spinal System

Indications for Use:

The Everest Spinal System if used in conjunction with the Range (Mesa and Denali) Spinal Systems are:

Non-cervical, pedicle screw fixation devices for posterior stabilization as an adjunct to fusion for the following indications: Trauma ( i.e. fracture or dislocation ); spinal stenosis; curvatures (i.e. scoliosis, kyphosis; and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. It is also indicated for the kyphono, and of lordone); cannot, por assates 3 and 4 ) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous boose 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.

Non-cervical, non-pedicle spinal fixation devices intended for posterior or anterolateral thoracolumber screw stabilization as an adjunct to fosion for the following indications: degenerative disc disease (DDD ) (defined stabilization as in adjunct to rasson for degeneration of the disc confirmed by history and radiographic studies as back pan of thisolgonio origin was acgr dislocation ); spinal stenosis; curvatures ( i.e. scoliosis, <yphosis; 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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

K120656 510(k) Number.