INCITE ANCHORED CERVICAL INTERBODY (ACI) FUSION DEVICE

K122008 · Incite Innovation, LLC · OVE · Nov 16, 2012 · Orthopedic

Device Facts

• Record ID: K122008
• Device Name: INCITE ANCHORED CERVICAL INTERBODY (ACI) FUSION DEVICE
• Applicant: Incite Innovation, LLC
• Product Code: OVE · Orthopedic
• Decision Date: Nov 16, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Incite Anchored Cervical Interbody Device is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Incite Anchored Cervical Interbody Device is to be used with autogenous bone graft and implanted via an open, anterior approach. Supplemental fixation, i.e. an anterior cervical plate, is required to properly utilize this system.

Device Story

Interbody fusion spacer; maintains intervertebral spacing and angulation. Implanted via open anterior approach by surgeons. Requires autogenous bone graft and supplemental anterior cervical plate fixation. Benefits patients by facilitating spinal fusion in DDD cases.

Clinical Evidence

Bench testing only. Performed axial compression, compression-shear, and torsion (static/dynamic) per ASTM F2077; subsidence per ASTM F2267; expulsion per ASTM Draft F04.25.0202; and cadaver lab evaluation.

Technological Characteristics

Materials: PEEK, Ti6Al4V titanium alloy, tantalum radiopaque markers. Form factor: Interbody spacer. Standards: ASTM F2077 (axial compression, compression-shear, torsion), ASTM F2267 (subsidence), ASTM Draft F04.25.0202 (expulsion).

Indications for Use

Indicated for skeletally mature patients with cervical degenerative disc disease (DDD) and radicular symptoms at one level (C2-T1). Requires six weeks of failed non-operative treatment. Must be used with autogenous bone graft and supplemental anterior cervical plate 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

• LDR Spine - Cervical Interbody Fusion System, ROI-C (K091088)
• Zimmer Spine - BAK/Cervical (BAK/C®) Interbody Fusion System (P984008)

Submission Summary (Full Text)

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#### 510(K) SUMMARY

# NOV 1 6 2012

#### Submitter Information

| Submitter's Name:<br>Address: | Incite Innovation LLC<br>P.O. Box 15388<br>1500 Main Street, Ste 2410<br>Springfield, MA 01115-5707 |
|-------------------------------|-----------------------------------------------------------------------------------------------------|
| Telephone: | 413-382-0212 |
| Contact Person: | John Kirwan |

| Date Prepared: | October 22, 2012 |
|--------------------|--------------------------------------------------------|
| Device Trade Name: | Incite Anchored Cervical Interbody Fusion (ACI) Device |
| Common/Usual Name: | Spinal Intervertebral body fixation orthosis |
| Classification: | 21 CFR §888.3080 |
| Class: | II |
| Product Code: | OVE |

#### Predicate Devices:

LDR Spine - Cervical Interbody Fusion System, ROI-C, K091088

Zimmer Spine - BAK/Cervical (BAK/C®) Interbody Fusion System, P984008

#### Intended Use:

The Incite Anchored Cervical Interbody Device is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Incite Anchored Cervical Interbody Device is to be used with autogenous bone graft and implanted via an open, anterior approach. Supplemental fixation, i.e. an anterior cervical plate, is required to properly utilize this system.

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#### Device Description:

The Incite Anchored Cervical Interbody Fusion Device acts as a spacer to maintain proper Intervertebral and vertebral body spacing and angulation. The Incite Anchored Cervical Interbody Fusion Device is manufactured from PEEK and Ti6A14V titanium alloy with tantalum radiopaque markers.

#### Predicate Device(s):

The Incite Anchored Cervical Interbody Fusion Device was shown to be substantially equivalent to previously cleared devices and had the same indications for use, design, function, and materials used.

#### Performance Testing:

Testing performed on this device indicates that the Incite Anchored Cervical Interbody Fusion Device is substantially equivalent to predicate devices and suitable for its intended use. Testing performed includes:

- . Axial Compression - Static and Dynamic per ASTM F2077
- . Compression-Shear - Static and Dynamic per ASTM F2077
- Torsion Static and Dynamic per ASTM F2077 .
- . Subsidence per ASTM 2267
- Expulsion per ASTM Draft F04.25.0202
- . Cadaver Lab

#### Substantial Equivalence:

When considering indications for use, design, materials, and function the Incite Anchored Cervical Interbody Fusion Device was shown to be substantially equivalent to previously cleared devices.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Letter Dated: November 16, 2012

Incite Innovation, LLC % Mr. John Kirwan President 1500 Main Street, Suite 2410 Springfield, Massachusetts 01115

Re: K122008

Trade Name: Incite Anchored Cervical Interbody Fusion Device Regulation Number: 21 CFR 888.3080 · Regulation Name: Intervertebral Body Fusion Device Regulatory Class: Class II Product Code: OVE Dated: November 7, 2012 Received: November 8, 2012

Dear Mr. Kirwan:

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

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Page 2 - Mr. John Kirwan

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 (OS) 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/Industrv/default.htm.

Sincerely yours,

## Laurence D. Coyne

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

Enclosure

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### Indications for Use Statement

#### 510(k) Number (if known): K122008

The Incite Anchored Cervical Interbody Device is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from C2-T1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These patients should have had six weeks of non-operative treatment. The Incite Anchored Cervical Interbody Device is to be used with autogenous bone graft and implanted via an open, anterior approach. Supplemental fixation, i.e. an anterior cervical plate, is required to properly utilize this system.

Prescription Use X (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)


(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

K122008 510(k) Number_