CERVICAL CAGE

K110915 · Eisertech, LLC · ODP · Jul 22, 2011 · Orthopedic

Device Facts

• Record ID: K110915
• Device Name: CERVICAL CAGE
• Applicant: Eisertech, LLC
• Product Code: ODP · Orthopedic
• Decision Date: Jul 22, 2011
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cervical Cage is intended for spinal fusion procedures at one level (C2 to T1) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are intended to be packed with autogenous bone graft. The Cervical Cage is intended to be used with a supplemental fixation system.

Device Story

Cervical Cage is an intervertebral body fusion orthosis; provides mechanical support to cervical spine; maintains intervertebral spacing post-discectomy; protects autogenous bone graft from excessive loads to facilitate fusion. Used in cervical spinal fusion surgery; operated by surgeons. Device design requirements derived from biomechanical loads; performance validated through bench testing. Output is physical stabilization of vertebral segments; clinical benefit is promotion of spinal fusion in patients with degenerative disc disease.

Clinical Evidence

Bench testing only. No clinical data provided. Performance evaluated via ASTM F2077 (static/dynamic axial compression, static/dynamic torsion) and ASTM F2267 (subsidence). Expulsion testing performed against grade 15 polyurethane foam with 100 N axial preload.

Technological Characteristics

Intervertebral body fusion orthosis. Mechanical support device. Testing conducted per ASTM F2077 and ASTM F2267. No specific material composition or software/algorithm components described.

Indications for Use

Indicated for skeletally mature patients requiring spinal fusion at one level (C2 to T1) for degenerative disc disease of the cervical spine, characterized by discogenic back pain confirmed by history and radiography. Must be used with autogenous bone graft and supplemental 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

• Aesculap CeSpace PEEK Spinal Implant System (K083311)
• Spinal Elements Crystal Cervical Interbody System (K073351)
• Signus Medical, LLC Rabea implant (K082848)
• Nuvasive CoRoent-S (K081611)
• Alphatec Spine, Inc. Novel Cervical Spine System (K081730)

Submission Summary (Full Text)

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K110915 Page 1/2

JUL 222 2011

| Company: | Eisertech, LLC<br>San Diego, California 92103 |
|--------------------------|------------------------------------------------------------|
| Contact: | Lukas Eisermann<br>[e-mail]<br>888-262-2817x101 |
| Trade Name: | Cervical Cage |
| Common Name:<br>Cervical | Intervertebral FusionDevice with Bone Graft |
| Classification Name: | Orthosis, spinal intervertebral fusion |
| Regulation Number: | 888.3080 |
| Product Code: | ODP |

# Substantial Equivalence

510(k) Summary:

Eisertech, LLC believes that the Eisertech, LLC Cervical Cage is substantially equivalent to the Aesculap CeSpace PEEK Spinal Implant System (k083311), the Spinal Elements Crystal Cervical Interbody System (k073351), the Signus Medical, LLC Rabea implant (k082848), the Nuvasive CoRoent-S (k081611), and the Alphatec Spine, Inc. Novel Cervical Spine System (k081730).

### Description of device and its intended use

The Cervical Cage is intended for spinal fusion procedures at one level (C2 to T1) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are intended to be packed with autogenous bone graft. The Cervical Cage is intended to be used with a supplemental fixation system.

# Description of device design requirements

The Cervical Cage design must maintain the spacing between two vertebral bones following cervical discectomy until fusion occurs.

### ldentification of the risk analysis method

Risks were qualitatively summarized and addressed by quantitatively analyzing specific in-vivo device performance requirements. The biomechanical loads that the device is expected to be subjected to were described and used as design input criteria. Test results relative to those loading conditions (e.g. design output data) were compared to the design input criteria. The device output data showed

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performance meeting or exceeding the design input requirements for all conditions.

# Discussion of the device characteristics

The Cervical Caqe is an intervertebral body fusion orthosis intended to be used in cervical spinal fusion surgery. It provides mechanical support to the spine and protects the bone graft from excessive loads so that bone healing can occur.

#### Description of the performance aspects

The Cervical Cage was tested by the methods described in ASTM F2077, including static axial compression, dynamic axial compression, static torsion, and dynamic torsion. Testing per ASTM F2267 to quantify the potential for device subsidence was also conducted. The resistance to expulsion was evaluated by performing expulsion testing against grade 15 polyurethane foam with 100 N axial preload.

The Cervical Cage performs at least as safely and effectively as a legally marketed predicate device.

#### Reliance on standards

Standards relevant to the methods in which the testing was conducted were relied upon. These include ASTM F2077 and ASTM F2267. However, no performance standard exists for intervertebral body fusion orthoses.

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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

#### Public Health Service

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

Eisertech, LLC % Mr. Lukas Eisermann 2555 Front Street San Diego, California 92103

ງປະ 2-2-2011

Re: K110915

Trade/Device Name: Cervical Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: ODP Dated: June 29, 2011 Received: June 30, 2011

Dear Mr. Eisermann:

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. Lukas Eisermann

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 (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/ReportalProblem/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,

yours,

Melkerson

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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510(k) Number (if known):

Cervical Cage Device Name:

Indications for Use:

The Cervical Cage is intended for spinal fusion procedures at one level (C2 to T1) in skeletally mature patients with degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are intended to be packed with autogenous bone graft. The Cervical Cage is intended to be used with a supplemental fixation system.

Prescription Use
(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)

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Division of Surgical, Orthopedic, and Restorative Devices

KI10915 510(k) Number_