The EVEREST Spinal System may be used in conjunction with the RANGE® (MESA® and DENALI®) Spinal Systems, all of which are cleared for the following indications:

Posterior non-cervical fixation as an adjunct to fusion for the following indications: degenerative disc disease (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; pseudarthrosis; and/or failed previous fusion.

Except for hooks, when used as an anterolateral thoracic/lumbar system the Everest Spinal System may also be used for the same indications as an adjunct to fusion.

When used for posterior non-cervical pedicle screw fixation in pediatric patients the Everest Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Device Description

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

Materials: The proposed implants are manufactured from Titanium per ASTM standards.

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

Purpose of Submission: Additional connectors

AI/ML Overview

This document is a 510(k) premarket notification for the Everest Spinal System. It does not describe a study to prove device performance against acceptance criteria for an AI/software device. Instead, it demonstrates substantial equivalence to predicate devices through mechanical testing for a physical implantable device.

Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI system based on the provided text.

The document discusses:

Device Name: Everest Spinal System
Submission Type: 510(k) premarket notification for "Additional Connectors" for an existing spinal system.
Device Type: Pedicle screw spinal system (physical implant).
Predicate Devices: Everest Spinal System (K140529) and Medtronic CD Horizon (K132328).
Testing: Mechanical testing performed in accordance with ASTM F1798 and ASTM F1717 (static torsion, static compression, and dynamic compression bending).
Conclusion: The device was found substantially equivalent to predicate devices, and the proposed implants do not represent a new worst case.

None of the information requested in points 1-9 (e.g., acceptance criteria for AI, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) is applicable or present in this document, as it pertains to a different type of medical device (hardware vs. software/AI).

Summary

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

January 21, 2015

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

Re: K142360

Trade/Device Name: Everest Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, OSH, MNH, MNI, KWQ, KWP Dated: December 9, 2014 Received: December 10, 2014

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 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Nancy Giezen

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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Vincent J. Devlin -S

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

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Indications for Use

510(k) Number (if known) K142360

Device Name Everest Spinal System

Indications for Use (Describe)

The EVEREST Spinal System may be used in conjunction with the RANGE® (MESA® and DENALI®) Spinal Systems, all of which are cleared for the following indications:

Except for hooks, when used as an anterolateral thoracic/lumbar system the Everest Spinal System may also be used for the same indications as an adjunct to fusion.

When used for posterior non-cervical pediale screw fixation in pediatric patients the Everest Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary for the Everest Spinal System: Additional Connectors

This 510(k) summary for the Everest Spinal System is provided as required per 21 CFR 807.92

1. Submitter :K2M, Inc.751 Miller Drive SE,Leesburg, VA 20175Date Prepared: 12/9/2014	Contact Person :Nancy GiezenK2M, Inc.Telephone: 703-777-3155
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2. Tradename:	Everest Spinal System
Common Name:	Spinal Fixation System
Regulatory Class:	Class II, Class III (NKB)
Pedicle Screw Spinal System	(21 CFR 888.3070)	(NKB, OSH, MNH, MNI)
Spinal Intervertebral body fixation Orthosis	(21 CFR 888.3060)	(KWQ)
Spinal Interlaminal fixation Orthosis	(21 CFR 888.3050)	(KWP)

3. Predicate or legally marketed devices which are substantially equivalent : Primary Predicate Everest Spinal System (K140529)

Additional Predicates

Medtronic CD Horizon (K132328) .

4. Description of the device:

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

Materials: The proposed implants are manufactured from Titanium per ASTM standards.

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

Purpose of Submission: Additional connectors

5. Indications For Use:

The EVEREST Spinal System may be used in conjunction with the RANGE® (MESA® and DENALI®) Spinal Systems, all of which are cleared for the following indications:

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Except for hooks, when used as an anterolateral thoracic/lumbar system the Everest Spinal System may also be used for the same indications as an adjunct to fusion.

6. Technological Comparison to Predicate(s)

The proposed Everest implants were compared to predicate systems and the design features, materials and sizes were found to be substantially equivalent to these systems.

7. Comparison to predicate and legally marketed devices:

Mechanical testing was conducted in accordance with ASTM F1798 and ASTM F1717 (including static torsion, static compression, and dynamic compression bending). The Everest Spinal System was found to be substantially equivalent to the predicate devices. The proposed implants were determined not to represent a new worst case.

8. Conclusion:

There are no significant differences between the Everest Spinal System and the predicate devices which would adversely affect the use of the product.

Regulation Number and Section

N/A