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 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 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 IBF 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 implants have machined teeth which are designed to engage with the vertebral body end plates.

Materials: The devices are manufactured from Medical Grade PEEK (Polyetheretherketone) OPTIMA® LT1 (Invibio™) per ISO 10993-1 USP Class VI and ASTM F2026. Tantalum beads /rods to be 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.

AI/ML Overview

The provided text describes a 510(k) summary for the Aleutian IBF System, which is an intervertebral body fusion device. The focus of the document is on establishing substantial equivalence to previously cleared predicate devices, primarily through comparison of technological characteristics and preclinical testing.

Based on the information provided, here's an analysis of the acceptance criteria and study as requested:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Mechanical/Physical Equivalence	Demonstrated through Finite Element Analysis (validated by static compression and static torsion testing per ASTM F2077) to show that added components would not result in a new worst-case device.
Material Equivalence	Devices are manufactured from Medical Grade PEEK (Polyetheretherketone) OPTIMA® LT1 (Invibio™) per ISO 10993-1 USP Class VI and ASTM F2026. Tantalum beads/rods are Grade UNS R05200, UNS R05400 according to ASTM F560, consistent with accepted medical device materials.
Biocompatibility	PEEK material specified as compliant with ISO 10993-1 USP Class VI.
Intended Use Equivalence	Indications for use for cervical, lumbar, and vertebral body replacement applications align with existing cleared devices for similar spinal fusion and stabilization purposes.
Substantial Equivalence to Predicates	Documentation provided demonstrating substantial equivalence to K2M's Aleutian IBF System (K051454, K063399, K080024, K082698, K101302), DePuy AcroMed's Cougar and Bengal (K081917), and Alphatec's Novel (K080699).

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not applicable. This submission relies on preclinical testing (Finite Element Analysis and static mechanical testing) and comparison to predicate devices, not clinical patient data with a test set.
Data Provenance: Not applicable in terms of country of origin or retrospective/prospective human data. The testing described is preclinical engineering analysis and mechanical testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. As a preclinical mechanical evaluation, there's no "ground truth" derived from expert clinical interpretation of data in the way one would for diagnostic imaging. Expertise in biomechanical engineering and material science would have been involved in the design and interpretation of the Finite Element Analysis and mechanical testing.

4. Adjudication Method for the Test Set

Not applicable. There is no clinical test set requiring adjudication in this submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (e.g., AI in radiology) comparing human performance with and without AI assistance. This document is for an intervertebral body fusion device, which is a physical implant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone (algorithm only) performance study was not done. This concept is applicable to software or AI algorithms. The device is a physical medical implant.

7. The Type of Ground Truth Used

For the preclinical testing mentioned (Finite Element Analysis and static compression/torsion), the "ground truth" refers to established engineering principles, material properties (e.g., ASTM F2077 standards for spinal implants), and the performance characteristics of the predicate devices. The aim was to demonstrate that the new device components do not introduce new safety or effectiveness concerns compared to these established benchmarks.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set, there is no corresponding ground truth to establish for it.

In summary: The provided document is a 510(k) summary for a physical medical implant, the Aleutian IBF System. The "study" described is a preclinical engineering evaluation consisting of Finite Element Analysis validated by static compression and torsion testing. Acceptance criteria revolve around demonstrating substantial equivalence in technological characteristics (materials, design, mechanical performance) and intended use to existing legally marketed predicate devices, rather than clinical performance metrics in a patient population or AI model performance.

Summary

{0}------------------------------------------------

510(k) Summary Aleutian IBF System K2M, Inc.

This safety and effectiveness summary for the Aleutian IBF 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:	March 24, 2011
Contact Person :	Nancy Giezen
	K2M, Inc.
	751 Miller Drive SE, Suite F1
	Leesburg, VA 20175
	Telephone: 703-777-3155

JUN 2 2 2011

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:

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

4. Intended Use:

page 1 of 2

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows a handwritten alphanumeric string. The string is "K110843". The characters are written in a simple, slightly slanted style, with varying stroke thicknesses.

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.

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

Documentation was provided which demonstrated that the subject Aleutian IBF System components are substantially equivalent to devices previously cleared in K2M's Aleutian IBF System (K051454, K063399, K080024, K082698, K101302), DePuy AcroMed's Cougar and Bengal (K081917) and Alphatec's Novel (K080699).

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

Finite element analysis (which was validated by static compression and static torsion testing per ASTM F2077) was performed to demonstrate that the components added to the Aleutian IBF System in this 510(k) submission would not result in a new worst-case device. The preclinical testing performed demonstrates that the subject devices are substantially equivalent to the predicates referenced.

page 2 of 2

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

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

K2M, Inc. % Ms. Nancy Giezen 751 Miller Drive, SE, Suite F1 Leesburg, Virginia 20175

JUN 2 2 2011

Re: K110843

Trade/Device Name: Aleutian IBF System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX, ODP, MQP Dated: June 02, 2011 Received: June 06, 2011

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

{3}------------------------------------------------

Page 2 - Ms. Nancy Giezen

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.

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 (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours,
E. L. Keith

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

510(k) Number (if known): KIT0843

Device Name : Aleutian IBF System

Indications For Use :

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

天天气气气气中式水木木木木木气温泉泉泉泉泉泉泉泉泉泉泉泉泉泉泉泉泉泉泉泉泉泉泉泉泉泉泉泉泉泉泉泉泉泉泉泉

Concurrence of CDRH, Office of Device Evaluation ( ODE )

Division Sign Off

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

KI10843 510(k) Number_

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.