Hedgehog Cervical Interbody Fusion Device

K143685 · Vertera, Inc. · ODP · Sep 23, 2015 · Orthopedic

Device Facts

• Record ID: K143685
• Device Name: Hedgehog Cervical Interbody Fusion Device
• Applicant: Vertera, Inc.
• Product Code: ODP · Orthopedic
• Decision Date: Sep 23, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Hedgehog Cervical Interbody Fusion Device is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one level of the cervical spine with accompanying radicular symptoms. Implants are used to facilitate fusion in the cervical spine (C3-C7) and are placed via an anterior approach using autogenous bone as graft material for the interior graft window. The device is intended to be used with supplemental fixation systems that have been cleared for use in the cervical spine.

Device Story

Hedgehog Cervical Interbody Fusion Device is a sterile, single-use PEEK implant for anterior cervical discectomy and fusion (ACDF) procedures. Device features a porous surface layer integrated directly into the PEEK body (Scoria™) to facilitate fusion; includes Tantalum marker bands for radiographic visualization. Used by surgeons in clinical settings to stabilize the cervical spine at one level. Implant is packed with autogenous bone graft and requires supplemental fixation systems. Device provides structural support to the intervertebral space, promoting spinal fusion and alleviating radicular symptoms associated with degenerative disc disease.

Clinical Evidence

Bench testing only. Testing included static and dynamic compression and torsion (ASTM F2077-11), load-induced subsidence (ASTM F2267-04), particle characterization (ASTM F1877-05), and expulsion testing. Results demonstrate performance equivalent to predicate devices.

Technological Characteristics

Material: Implant-grade PEEK with integrated porous surface layer (Scoria™) and Tantalum marker bands. Form factor: Varied footprints and heights for C3-C7. Standards: ASTM F2077-11, ASTM F2267-04, ASTM F1877-05. Sterilization: Sterile, single-use.

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (discogenic back pain with radiographic confirmation) at one level of the cervical spine (C3-C7) with radicular symptoms. Requires use with supplemental fixation and autogenous bone graft.

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

• Spinal Elements, Crystal® (K133218)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized representation of three human profiles facing to the right, stacked on top of each other. The profiles are depicted in a simple, flowing line style.

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

September 23, 2015

Vertera, Incorporated Mr. Stephen Laffoon Director of Engineering 311 Ferst Drive NW, Suite L1328 Atlanta, Georgia 30332

Re: K143685

Trade/Device Name: Hedgehog Cervical Interbody Fusion Device Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: September 21, 2015 Received: September 21, 2015

Dear Mr. Laffoon:

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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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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education 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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# Indications for Use

K143685 510(k) Number:

Device Name: Hedgehog Cervical Interbody Fusion Device

### Indications for Use:

The Hedgehog Cervical Interbody Fusion Device is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one level of the cervical spine with accompanying radicular symptoms. Implants are used to facilitate fusion in the cervical spine (C3-C7) and are placed via an anterior approach using autogenous bone as graft material for the interior graft window. The device is intended to be used with supplemental fixation systems that have been cleared for use in the cervical spine.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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# 510(k) Summary

Date Submitted: September 21, 2015

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92(e).

- A. Submitter: Vertera. Inc. 311 Ferst Drive NW, Suite L1328 Atlanta, Georgia 30332
- B. Company Contact: Stephen Laffoon Director of Engineering [phone] [e-mail]
- C. Device Information: Trade Name(s): Hedgehog Cervical Interbody Fusion Device

Common Name(s): Cervical Interbody Fusion Device

- D. Classification Name: Intervertebral Body Fusion Device, 888.3080
- E. Product Code: ODP, Intervertebral Body Fusion Device, Cervical
- F. Predicate Device(s): Spinal Elements, Crystal®, K133218
- G. Physical Description:

The proposed Hedgehog Cervical Interbody Fusion Device is a sterile, single use implant grade polyetheretherketone (PEEK) device, available in varied footprints and heights, designed for supplemental stabilization of the cervical spinal column in anterior cervical discectomy and fusion (ACDF) procedures.

The Hedgehog Cervical device is comprised of a single, continuous piece of PEEK Scoria™ formed into the final product shape. The Vertera device remains solid with a surface porous layer on the top surface of the implant body. This porous surface is derived directly from the implant body and is not a sintered or otherwise additive coating. In addition to PEEK, the cage assembly will have two marker bands, made from Tantalum, to enable visibility under xray.

- H. Indications for Use:
The Hedgehog Cervical Interbody Fusion Device is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic neck pain with degeneration of the disc confirmed by patient history and radiographic studies) at one level of the

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cervical spine with accompanying radicular symptoms. Implants are used to facilitate fusion in the cervical spine (C3-C7) and are placed via an anterior approach using autogenous bone as graft material for the interior graft window. The device is intended to be used with supplemental fixation systems that have been cleared for use in the cervical spine.

- l. Comparison of Technological Characteristics:
The Hedgehog Cervical Interbody Fusion Device is substantially equivalent in function and intended use to the following predicate device:

Spinal Elements, Crystal®K133218

All devices are comprised of implant grade PEEK and utilize tantalum markers. All devices have the same indications for use.

- J. Non-Clinical Testing
In addition, functional performance testing has been conducted per applicable standards as recommended in the guidance document. These are (ASTM) F2077-11, Test Methods for Intervertebral Body Fusion Devices in static and dynamic compression and torsion, (ASTM) F2267-04, Standard Test Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device Under Static Axial Compression, (ASTM) F1877-05, Standard Practice for Characterization of Particles, and Expulsion Testing. Non-clinical testing has demonstrated substantially equivalent performance to predicate devices.

#### K. Conclusion

Analysis of the results supports the conclusion that the proposed device is substantially equivalent to the predicate devices.