ACCULIF XL CAGE

K130194 · Coalign Innovations, Inc. · MAX · Apr 3, 2013 · Orthopedic

Device Facts

• Record ID: K130194
• Device Name: ACCULIF XL CAGE
• Applicant: Coalign Innovations, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Apr 3, 2013
• 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 XL 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 CoAlign Innovations AccuLIF XL Cage is always to be used with supplemental internal spinal fixation. Additionally, the CoAlign Innovations AccuLIF XL Cage is to be used with autogenous bone graft.

Device Story

AccuLIF XL Cage is an expandable intervertebral body fusion spacer; used to maintain disc space and angulation post-discectomy. Device consists of TI6Al4V ELI (ASTM F136-08), 316 LVM stainless steel (ASTM F138-08), PEEK (ASTM F2026-07), and silicone rubber. Inserted in unexpanded state via articulating delivery handle; expanded in-situ using hydraulic system (disposable flexible tubing and inflation syringe); locks in 1mm increments. Features fixation ridges and graft opening window. Used in spinal surgery by physicians; requires supplemental internal fixation. Benefits include restoration of disc height and facilitation of fusion in DDD patients.

Clinical Evidence

Bench testing only. Conducted dynamic/static compression and shear testing per ASTM F2077-03, static subsidence per ASTM F2267-04, and static expulsion per draft standard F-04.25.02.02. Surgical technique validated against predicate.

Technological Characteristics

Expandable intervertebral spacer. Materials: TI6Al4V ELI (ASTM F136-08), 316 LVM stainless steel (ASTM F138-08), PEEK (ASTM F2026-07), silicone rubber (MED-4870). Expansion via hydraulic cylinder/piston mechanism. Sizes: 6-16mm height, various footprints. Fixation ridges on surfaces. Graft window included.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1, including those with up to Grade I spondylolisthesis or retrolisthesis, who have failed six months of non-operative treatment. Must be used with autogenous bone graft and 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

• AccuLIF TL-PEEK Cage (K123281)
• AccuLIF TL Cage (K1216835)
• AccuLIF TL Cage (K113465)
• SEC Interbody Fusion Cage (K093669)

Submission Summary (Full Text)

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CoAlign Innovations AccuLIF XL Cage Special 510(k)

# 510(k) Summary

3 2013 APR

| 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 25, 2013 |
| Device Trade Name: | AccuLIF® XL 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 |

## Device Description:

The AccuLIF XL Cage acts as a spacer to maintain proper intervertebral spacing and angulation following discectomy. The AccuLIF XL Cage is manufactured from TI6Al4V ELI) as per ASTM F136-08, Stainless Steel (316 LVM) as per ASTM F138-08, PEEK (Invibio Optima LTI) as per ASTM F2026-07, and Silicone Rubber (MED-4870). The device is inserted in unexpanded state with an articulating delivery handle and expanded in-situ to the required height via 2 hydraulic cylinder and piston arrangement using a hydraulic system comprising disposable flexible expansion tubing set and inflation syringe. The device locks in 1mm increments as it expands. The AccuLIF XL Cage comes in 6 to 9mm, 8 to 12mm and 10 to 16mm sizes. The device has fixation ridges on the top and bottom surface. In addition each size comes in 4 foot prints 1) 45mm length x 18mm width, 2) 45mm length x 22mm width, 3) 60mm length x 18mm width, and 4)

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CoAlign Innovations AccuLIF XL Cage Special 510(k)

60mm length x 22mm width. It also has a graft opening window which extends from the bottom surface to the top surface. The device has a proximal boss which has a threaded connection port for connecting to the inserter and a fluid port for transporting the expansion fluid

### Indications For Use:

Intervertebral Body Fusion Device: The CoAlign Innovations AccuLIF XL 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 SI. 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 CoAlign Innovations AccuLIF XL Cage is always to be used with supplemental internal spinal fixation. Additionally, the CoAlign Innovations AccuLIF XL Cage is to be used with autogenous bone graft.

#### Identification of Predicates

- AccuLIF TL-PEEK Cage (K123281) -
- -AccuLIF TL Cage (K1216835)
- AccuLIF TL Cage (K113465) -
- SEC Interbody Fusion Cage (K093669) -

#### Summary of Technological Characteristics

AccuLIF XL Cages are expandable spacers made from Titanium-6AL-4V ELI alloy that conforms to ASTM F136 and PEEK (Invibio Optima LT1) that conforms to ASTM F2026-07. 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
- Expansion mechanism -
- -Structural support mechanism

#### 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
- -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 Subsidence testing, conducted in accordance with ASTM F2267-04
- Static Expulsion testing, conducted in accordance with -ASTM Draft Standard F-04.25.02.02
- 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 predicate device testing represented a worst case such that any minor differences do not impact device performance as compared to the predicates. The AccuLIF XL Cage was shown to be substantially equivalent to the AccuLIF-PEEK Cage (K123281), the AccuLIF TL Cage (K1216835 and K113465), and the SEC Interbody Fusion 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 stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol. The logo is black and white.

Letter dated: April 3, 2013

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

CoAlign Innovations, Incorporated % Musculoskeletal Clinical Regulatory Advisers, LLC Mr. Justin Eggleton Director, Spine Regulatory Affairs 1331 H Street NW, 12th Floor Washington, District of Columbia 20005

Re: K130194

Trade/Device Name: AccuLIF XL Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Dated: March 7, 2013 Received: March 8, 2013

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 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

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## Page 2 – Mr. Justin Eggleton

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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mark N!Melkerson -S

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

Enclosure

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K130194-Page 1 of 1

CoAlign Innovations AccuLIF XL Cage Special 510(k)

# Indications for Use

510(k) Number (if known): K130194

Device Name: AccuLIF XL Cage

Intervertebral Body Fusion Device: The CoAlign Innovations AccuLIF XL 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 CoAlign Innovations AccuLIF XL Cage is always to be used with supplemental internal spinal fixation. Additionally, the CoAlign Innovations AccuLIF XL Cage is to be used with autogenous bone graft.

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Anton E. Dmitriev, PhD Division of Orthopedic Devices