ALEUTIAN SYSTEM

K113138 · K2m, Inc. · MAX · Jan 10, 2012 · Orthopedic

Device Facts

• Record ID: K113138
• Device Name: ALEUTIAN SYSTEM
• Applicant: K2m, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Jan 10, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 I 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 Story

Aleutian Spinal System consists of hollow, horseshoe-shaped implants; manufactured from PEEK (Polyetheretherketone) with tantalum markers; available in various sizes/heights to match patient anatomy; machined teeth engage vertebral endplates. Used in spinal fusion or vertebral body replacement procedures; implanted by surgeons in clinical settings. Provides stabilization and support to cervical, lumbar, or thoracolumbar spine segments; restores biomechanical integrity and vertebral height. Must be used with supplemental internal fixation (e.g., pedicle screws, hooks, plates). Benefits include decompression of neural tissues and stabilization of spinal column.

Clinical Evidence

Bench testing only. Finite element analysis validated by static compression and static torsion testing per ASTM F2077.

Technological Characteristics

Materials: Invibio PEEK OPTIMA LT1 (ASTM F2026) and Tantalum (ASTM F560). Form factor: Hollow, horseshoe-shaped implants with machined teeth. Energy source: None (mechanical). Connectivity: None. Sterilization: Not specified. Software: None.

Indications for Use

Indicated for skeletally mature patients requiring spinal fusion or vertebral body replacement. Cervical: C2-T1, discogenic neck pain, 6 weeks failed non-operative treatment. Lumbar: L2-S1, degenerative disc disease with up to Grade I spondylolisthesis, 6 months failed non-operative treatment. Thoracolumbar (T1-L5): partial vertebrectomy for tumors or trauma/fracture to restore height and achieve decompression. Requires supplemental internal fixation.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Aleutian Spinal System (K082698)
• CoRoent System (K071795)
• DiFusion Technology (K100042)

Submission Summary (Full Text)

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

JAN 1 0 2012

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

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

| 1. Submitter : | Contact Person : |
|---------------------------------|-------------------------------|
| K2M, Inc. | Nancy Giezen |
| 751 Miller Drive SE | K2M, Inc. |
| Suite F1 | 751 Miller Drive SE, Suite F1 |
| Leesburg, VA 20175 | Leesburg, VA 20175 |
| | Telephone: [phone] |
| Date Prepared: January 10, 2011 | |

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

#### 3. Description of the device:

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 Invibio™ 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.

#### 4. Intended Use:

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 JBF 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 I 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.

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

KII3/38

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.

### 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), NuVasive's CoRoent System (K071795) and DiFusion Technology's (K100042).

## 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.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol.

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

K2M, Inc. % Ms. Nancy Giezen Manager Regulatory Affairs 71 Miller Drive SE, Suite F1 Leesburg, Virginia 20175

JAN 1 0 2012

Re: K113138

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, ODP, MQP Dated: December 16, 2011 Received: December 19, 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 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

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

Page 2 – Ms. Nancy Giezen

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set de rico-relation daverse or child/S) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality by steens over (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 n you about o specifica 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 note the regulations 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 I ba may over in ones gettirers, 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 vours.

Sincerely yours,
Euinel Keith

Sr 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): K/13138

#### Aleutian Spinal System Device Name :

# Indications For Use :

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.

Prescription use X

のめざーターのモーニーーーーーーーーーーーーーーーー

OR

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

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

Concurrence of CDRH, Office of Device Evaluation ( ODE ) (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

> KI13138 510(k) Number_