When used as a cervical intervertebral body fusion device, the Aleutian implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. Cervical IBF implants are intended for use at one level in the cervical spine, from C2 to T1, for the treatment of cervical disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). The cervical device is intended to be used in patients who have had six weeks of non-operative treatment.

When used as a lumbar intervertebral body fusion device, the Aleutian implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The lumbar IBF implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment.

When used as vertebral body replacement devices the Aleutian implants are indicated for use in the thoracolumbar spine (T1 to L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body, resected or excised for the treatment of tumors or trauma/fracture in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Aleutian implants are designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.

For all the above indications the Aleutian implants are intended to be used with supplemental internal fixation appropriate for the implanted level, including K2M Pedicle Screw and Hook Systems, and K2M Spinal Plate Systems.

Device Description

The Aleutian Spinal System consists of a hollow tube or horseshoe-shaped structures manufactured from Medical Grade PEEK (Polyetheretherketone). The devices are available in a variety of different sizes and heights to match more closely the patient's anatomy. The ends of the implants have machined teeth which are designed to engage with the vertebral body end plates.

Materials: The implants are manufactured from PEEK Optima LT1 per ASTM F2026. Tantalum beads/ rods are to be made of Grade UNS R05200, UNS R05400 according to ASTM F560.

Function: The system functions as an intervertebral body fusion device to provide support and stabilization of the cervical and lumbar segments of the spine.

The purpose of this submission is to incorporate additional lumbar implants into the system.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Aleutian Spinal System, an intervertebral body fusion device. It does not contain information about acceptance criteria or a study proving the device meets said criteria in the context of AI/ML performance.

Instead, the document focuses on:

Substantial Equivalence: The core of the submission is to demonstrate that the expanded Aleutian Spinal System (incorporating additional lumbar implants) is substantially equivalent to previously cleared Aleutian Spinal System devices and another predicate device (Zimmer InFix).
Device Description: Details on material (PEEK, Tantalum), function (support and stabilization for cervical and lumbar spine fusion), and available sizes.
Intended Use: Specific indications for cervical, lumbar, and vertebral body replacement, including conditions, levels, and required co-use with other fixation systems.
Biocompatibility and Mechanical Testing: The document mentions that previously cleared Aleutian spacers were tested in static compression, static torsion, and dynamic compression per ASTM F2077. It states that the proposed spacers were determined not to represent a new worst case based on Finite Element Analysis (FEA) and thus are considered substantially equivalent to predicates.

Therefore, I cannot populate the requested table or answer the specific questions about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/ML, as this information is not present in the provided text. The document is for a traditional medical device (spinal implant) and does not discuss AI/ML components or their performance studies.

Summary

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This safety and effectiveness summary for the Aleutian 18F System is provided as required per Section 513(i)(3) of the Food, Drug and Cosmetic Act.

Submitter : K2M, Inc. 751 Miller Drive SE Leesburg, VA 20175 Contact Person : Nancy Giezen K2M, Inc. Telephone: 703-777-3155

Date Prepared: March 29, 2013

2. Tradename:	Aleutian IBF System
Common Name:	Intervertebral Body Fusion Device
Classification Name:	Intervertebral Fusion Device with Bone Graft, lumbar (Product Code: MAX)Intervertebral Fusion Device with Bone Graft, cervical (Product Code: ODP)Spinal Vertebral Body Replacement Device (Product Code: MQP)
Regulation Number:	888.3080, 888.3060
Device Class:	Class II

3. Description of the device:

Materials: The implants are manufactured from PEEK Optima LT1 per ASTM F2026. Tantalum beads/ rods are to be made of Grade UNS R05200, UNS R05400 according to ASTM F560.

Function: The system functions as an intervertebral body fusion device to provide support and stabilization of the cervical and lumbar segments of the spine.

The purpose of this submission is to incorporate additional lumbar implants into the system.

4. Intended Use:

MAY 3 0 2013

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

Documentation was provided which demonstrated that the subject Aleutian Spinal System components are substantially equivalent to devices previously cleared in K2M's Aleutian Spinal System (K082698, 2 K101302, K103169, K110843, K113138) and to the Zimmer InFix device (K031672).

6. Comparison of the technological characteristics of the device to predicate and legally marketed devices:

Previously cleared Aleutian spacers were tested in static compression, static torsion and dynamic compression per ASTM F2077. The proposed spacers were determined not to represent a new worst case as determined by Finite Element Analysis and are considered substantially equivalent to the predicates referenced.

7. Conclusion:

There are no significant differences between the Aleutian 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's emblem, which is a stylized caduceus with a human figure in the center. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the emblem in a circular fashion. The emblem is black, and the text is also black.

Public Health Service

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

May 30, 2013

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

Re: K130699

Trade/Device Name: Aleutian Spinal System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: April 30, 2013 Received: April 30, 2013

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, Drugand 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 (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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

For

Sincerely yours,

ErinHDKeith

Mark N. Melkerson

-Director-Division of Orthopedic Devices_ Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K130699

Device Name : Aleutian Spinal System

Indications For Use :

When used as a lumbar intervertebral body fusion device, the Aleutian implants are indicated for spinal fusion procedures to be used with autogenous bone graft in skeletally mature patients. The lumbar IBF implants are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is intended to be used in patients who have had six months of non-operative treatment.

When used as vertebral body replacement devices the Aleutian implants are indicated for use in the thoracolumbar spine (T1 to L5) for partial replacement (i.e., partial vertebrectomy) of a diseased vertebral body, resected or excised for the treatment of turnors or trauma/fracture in order to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body. The Aleutian implants are designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period.

Prescription use X

Over-the-counter use ( PER 21 CFR 801.109)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

ページャー・アーペーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーーー

Concurrence of CDRH, Office of Device Evaluation ( ODE )

Anton E. Dmitriev, PhD Division of Orthopedic Devices

Regulation Number and Section

§ 888.3080 Intervertebral body fusion device.

(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.