CERVICAL CAGE

K122444 · Eisertech, LLC · ODP · Aug 30, 2012 · Orthopedic

Device Facts

• Record ID: K122444
• Device Name: CERVICAL CAGE
• Applicant: Eisertech, LLC
• Product Code: ODP · Orthopedic
• Decision Date: Aug 30, 2012
• Decision: SESE
• Submission Type: Special
• 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 fusion device; manufactured from PEEK (ASTM F2026); includes embedded tantalum pins (ASTM F560) for radiographic visualization. Device is implanted during spinal fusion surgery; packed with autogenous bone graft; used in conjunction with supplemental fixation system. Intended for use in skeletally mature patients with degenerative disc disease at one level (C2-T1). Tantalum markers allow surgeons to verify implant position via standard radiographic imaging post-operatively.

Clinical Evidence

No clinical data provided. Bench testing only; change in marker pin material determined not to affect device performance.

Technological Characteristics

Materials: PEEK (ASTM F2026) and tantalum radiographic markers (ASTM F560). Form factor: Intervertebral cage in various heights, widths, and lengths. Mechanical/passive device; no energy source or software.

Indications for Use

Indicated for skeletally mature patients requiring spinal fusion at one level (C2-T1) for degenerative disc disease of the cervical spine, confirmed by history and radiographic studies. 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

• Eisertech, LLC Cervical Cage (k110915)
• Nexxt Spine Honour Spacer System (k120345)

Submission Summary (Full Text)

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### 510(k) Summary:

Date:

August 29, 2012

# AUG 30 2012

Company:

Eisertech, LLC 1133 Columbia Street Suite 107 San Diego, California 92101

Contact:

Lukas Eisermann [e-mail] 888-262-2817x101

Type of 510(k) submission: Special

| Trade Name: | Cervical Cage |
|------------------------|----------------------------------------------------------|
| Common Name: | Intervertebral FusionDevice with Bone Graft,<br>Cervical |
| Classification Name: | Orthosis, spinal intervertebral fusion |
| Regulation Number: | 888.3080 |
| Device Classification: | Class II |
| Product Code: | ODP |

### Purpose of the Submission

The purpose of this special 510(k) is to change the material of the marker pins from titanium to tantalum, per ASTM F560.

### Description of device

The Cervical Cage is offered in a variety of heights, widths, and lengths. The implants are manufactured from medical grade polyetheretherketone (PEEK). Tantalum pins are embedded in the implants to help allow for radiographic visualization.

### 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.

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K122444 page 2 of 2

## Materials

The devices are manufactured from medical grade PEEK (ASTM F2026) with tantalum radiographic markers (ASTM F560)

### Predicate Devices

Eisertech, LLC Cervical Cage (k110915) Nexxt Spine Honour Spacer System (k120345)

### Technological Characteristics

The Cervical Cage geometry is unchanged from that approved in k110915. The main material of construction, PEEK is unchanged from that approved in k110915. The marker pin material is identical to that used in k120345.

#### Performance Data

The change in marker pin material does not affect the performance of the product. No additional testing or analysis is provided.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

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

AUG 30 2012

Eisertech, LLC % Mr. Lukas Eisermann Chief Executive Officer 1133 Columbia Street San Diego, California 92101

Re: K122444

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: August 08, 2012 Received: August 10, 2012

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 comply with all the Act's requirements, including, but not limited to: registration and listing (21

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### Page 2 -- Mr. Lukas Eisermann

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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Einl Keith

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):

Device Name: Cervical Cage

### Indications for Use:

. .

The Cervical Cage is intended for spinal fusion procedures at one level (C2 to T10 Our hour bage to a 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

K122444

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)

Page

Carl R.
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number k122444