ACCULIF CAGE

K110270 · Coalign Innovations, Inc. · MAX · Apr 7, 2011 · Orthopedic

Device Facts

• Record ID: K110270
• Device Name: ACCULIF CAGE
• Applicant: Coalign Innovations, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Apr 7, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Intervertebral Body Fusion Device: The CoAlign Innovations AccuLIF Cage is indicated for intervertebral body fusion with autogenous bone graft material in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment. The device is to be used with supplemental fixation. Vertebral Body Replacement: When used as a vertebral body replacement, the CoAlign Innovations AccuLIF Cage is intended for partial vertebral body replacement to aid in surgical correction and stabilization of the spine. The device is indicated for use in the thoracolumbar spine (T1 to L5) to replace or restore height a collapsed, damaged, diseased, or unstable portion of a vertebral body, excised as a result of tumor or trauma (i.e., fracture). It is indicated to achieve decompression of the spinal cord and neural tissues, and to restore the height of a collapsed or damaged vertebral body. The CoAlign Innovations AccuLIF Cage is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. The device is always to be used with supplemental internal spinal fixation. Additionally, the device may be used with bone graft.

Device Story

AccuLIF Cage is an expandable spinal spacer; maintains intervertebral/vertebral body spacing and angulation. Used in surgical procedures (discectomy, partial corpectomy, vertebral body replacement) to restore spinal height and biomechanical integrity. Operated by surgeons in clinical/OR settings. Device is implanted to support the anterior, middle, and posterior spinal column; requires supplemental internal spinal fixation. May be used with bone graft. Benefits include spinal stabilization, decompression of neural tissues, and restoration of vertebral height in patients with DDD, tumor, or trauma.

Clinical Evidence

Bench testing only. Conducted dynamic and static compression, shear, and torsion testing per ASTM F2077-03. Included wear assessments following dynamic testing and surgical technique validation.

Technological Characteristics

Expandable spacer; material: Titanium-6AL-4V ELI alloy (ASTM F136). Sizes: 6-9mm, 8-12mm, 10-16mm. Mechanical expansion mechanism. Non-implantable software/electronics. Sterilization method not specified.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels (L2-S1) with up to Grade I spondylolisthesis or retrolisthesis, requiring intervertebral body fusion with autogenous bone graft; also indicated for partial vertebral body replacement in the thoracolumbar spine (T1-L5) for collapsed, diseased, or unstable vertebrae due to tumor or trauma. Must be used with supplemental internal spinal 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

• SEC IBF Cage (K093669)

Submission Summary (Full Text)

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KI10270

## APR - 7 2011

# 510(k) Summary

| Submitted By: | CoAlign Innovations<br>150 North Hill Drive, Suite 1<br>Brisbane, CA 94005 |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment<br>Registration Number: | 10030843 |
| Contact Person:<br>(Submission Prepared by) | Justin Eggleton<br>Musculoskeletal Clinical & Regulatory Advisers, LLC<br>1331 H Street NW, 12th Floor<br>Washington, DC 20005<br>202.552.5800 |
| Date Prepared: | January 27, 2011 |
| Device Trade Name: | AccuLIF Cage |
| Manufacturer: | CoAlign Innovations, Inc.<br>150 North Hill Drive, Suite 1<br>Brisbane, CA 94005 |
| Common Name: | Spinal intervertebral body fixation orthosis |
| Classification: | 21 CFR §888.3080 |
| Class: | II |
| Product Code: | MAX, MQP |

### Device Description:

The AccuLIF Cage acts as a spacer to maintain proper intervertebral and vertebral body spacing and angulation following discectomy or partial corpectomy. The AccuLIF Cage is manufactured from Ti6Al4V and stainless steel. The AccuLIF Cage comes in 6 to 9mm, 8 to 12mm and 10 to 16mm sizes.

### Indications For Use:

Intervertebral Body Fusion Device: The CoAlign Innovations AccuLIF Cage is indicated for intervertebral body fusion with autogenous bone graft material in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I

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spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment. The device is to be used with supplemental fixation.

Vertebral Body Replacement: When used as a vertebral body replacement, the CoAlign Innovations AccuLIF Cage is intended for partial vertebral body replacement to aid in surgical correction and stabilization of the spine. The device is indicated for use in the thoracolumbar spine (T1 to L5) to replace or restore height a collapsed, damaged, diseased, or unstable portion of a vertebral body, excised as a result of tumor or trauma (i.e., fracture). It is indicated to achieve decompression of the spinal cord and neural tissues, and to restore the height of a collapsed or damaged vertebral body.

The CoAlign Innovations AccuLIF Cage is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. The device is always to be used with supplemental internal spinal fixation. Additionally, the device may be used with bone graft.

## Identification of Predicates

#### SEC IBF Cage (K093669) -

### Summary of Technological Characteristics

AccuLIF Cages are expandable spacers made from Titanium-6AL-4V ELI alloy that conforms to ASTM F136. The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically the following characteristics are identical between the subject and predicates:

- Indications for Use -
- Materials of manufacture -
- -Device footprint
- Bone graft port -
- Expansion mechanism -
- Structural support geometry -

### Discussion of Testing:

The following non-clinical tests were conducted:

- Dynamic compression testing, conducted in accordance with ASTM F2077-03
- Dynamic shear testing, conducted in accordance with -ASTM F2077-03
- Dynamic torsion testing, conducted in accordance with -ASTM F2077-03
- Static compression testing, conducted in accordance with ASTM F2077-03
- -Static shear testing, conducted in accordance with ASTM F2077-03

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- Static torsion testing, conducted in accordance with ASTM F2077-03
- Wear assessments following dynamic compression, dynamic shear, and dynamic torsion testing
- . Surgical technique validation, conducted in the same manner as the predicate surgical technique validation.

### Conclusions:

The subject and predicate devices share the same indications for use, design, function, and materials of manufacture. The non-clinical test results demonstrate that any minor differences do not impact device performance as compared to the predicates. The AccuLIF Cage was shown to be substantially equivalent to the SEC IBF Cage (K093669).

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. 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 emblem featuring a stylized eagle with outstretched wings, symbolizing the department's mission to protect and promote the health and well-being of the nation.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

CoAlign Innovations, Inc. % Musculoskeletal Clinical Regulatory Advisors, LLC Mr. Justin Eggleton 1331 H Street, Northwest, 12th Floor Washington, District of Columbia 20005

Re: K110270

APR - 7 2011

· Trade/Device Name: AccuLIF Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: MAX, MQP Dated: March 8, 2011 Received: March 10, 2011

Dear Mr. Eggleton:

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

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Page 2 - Mr. Justin Eggleton

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

A. B. R.A
fer

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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### Indications for Use 4.

510(k) Number (if known): ≤110220_

Device Name: AccuLIF Cage

Intervertebral Body Fusion Device: The CoAlign Innovations AccuLIF Cage is indicated for intervertebral body fusion with autogenous bone graft material in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment. The device is to be used with supplemental fixation.

Vertebral Body Replacement: When used as a vertebral body replacement, CoAlign Innovations AccuLIF Cage is intended for partial vertebral body replacement to aid in surgical correction and stabilization of the spine. The device is indicated for use in the thoracolumbar spine (T) to LS) to replace or restore height a collapsed, diseased, or unstable portion of a vertebral body. excised as a result of tumor or trauma (i.e., fracture). It is indicated to achieve decompression of the spinal cord and neural tissues, and to restore the height of a collapsed or damaged vertebral body.

The CoAlign Innovations Accul.IF Cage is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column even in the absence of fusion for a prolonged period. The device is always to be used with supplemental internal spinal fixation. Additionally, the device may be used with bone graft.

Prescription Use ਪ (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-(1) Division of Sur ... . Orthopedic, and Restorative Devices

KII0270 : ! ^( ) Number___

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