DORADO WIDE INTERVERTEBRAL BODY CAGE, MODELS: IM2010-IM2031

K091638 · Spinefrontier, Inc. · MAX · Sep 14, 2009 · Orthopedic

Device Facts

• Record ID: K091638
• Device Name: DORADO WIDE INTERVERTEBRAL BODY CAGE, MODELS: IM2010-IM2031
• Applicant: Spinefrontier, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: Sep 14, 2009
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DORADO™ Wide Intervertebral Body Cage is a spinal intervertebral body cage intended for a posterior approach and uses autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolithesis at the involved level(s). The SpineFrontier DORADO™ Wide Intervertebral Body Cage is intended to be used with supplemental spinal fixation system(s) (Example: Posterior Pedicle Screw). Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history or radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

Device Story

Dorado Wide Intervertebral Body Cage is a spinal implant for posterior lumbar interbody fusion. Device features fixed heights and footprints with superior/inferior surface contours to resist expulsion. Implanted by surgeons during spinal fusion procedures to facilitate bone growth using autogenous bone graft. Used in conjunction with supplemental posterior pedicle screw fixation systems. Provides structural support to the intervertebral space in patients with degenerative disc disease. Benefits include stabilization of spinal segments and potential reduction of discogenic back pain.

Clinical Evidence

Bench testing only; no clinical data required.

Technological Characteristics

Intervertebral body fusion device; fixed height/footprint geometry; superior/inferior surface contours for expulsion resistance; intended for use with autogenous bone graft and supplemental posterior pedicle screw fixation.

Indications for Use

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

• Dorado Intervertebral Body Cage (K072289)
• Saber Lumbar I/F Cage (P960025)
• Jaguar Lumbar I/F Cage (P960025)

Submission Summary (Full Text)

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# SEP 1 4 2009

## 510(k) Summarv

# 1. Sponsor

SpineFrontier, Inc. 500 Cummings Center Suite 3500

Beverly, MA 01915

Primary Contact: John Sullivan Telephone: [phone]

Date Prepared: May 29, 2009

#### 2. Device Name and Classification:

Dorado ™ Wide Intervertebral Body Cage, Proprietary Name: Dorado™ Wide IBC, Dorado™ Wide IBF Common/Usual Name: Intervertebral Fusion Device With Bone Graft. Lumbar Classification Name: Intervertebral Fusion Device With Bone Graft, Lumbar, (21 CFR 888.3080), Class II Product Code: MAX

#### 3. Predicate Devices

K072289 - SpineFrontier Inc., Dorado Intervertebral Body Cage P960025 - Saber Lumbar I/F Cage and Jaguar Lumbar I/F Cage

#### 4. Device Description

The DORADO™ Wide Intervertebral Body Cage is a spinal intervertebral body cage intended for a posterior approach and uses autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2-S1. The system is comprised of devices of various fixed heights and footprints to fit the anatomical needs of a wide variety of patients. The device has raised contours on the superior and inferior surfaces that will resist implant expulsion.

SpineFrontier, Inc. Dorado " Wide Intervertebral Body Cage - Supplement to Abbreviated 510(k) K091638 September 1, 2009

Company Confidential

5.0

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K09638 page 2/2

#### 5. Intended Use

The DORADO™ Wide Intervertebral Body Cage is a spinal intervertebral body cage intended for a posterior approach and uses autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolithesis at the involved level(s). The SpinaFrontier DORADO™ Wide Intervertebral Body Cage is intended to be used with supplemental spinal fixation system(s) (Example: Posterior Pedicle Screw). Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history or radiographic studies. These patients should be skeletally mature and have had six months of nonoperative. treatment.

#### 6. Technological Characteristics

The SpineFrontier Dorado™ Wide Intervertebral Body Cage was shown to be substantially equivalent to predicate devices through comparison of indications for use, function, operating principles, and materials,

# 7. Basis for Substantial Equivalence

The Dorado™ Wide Intervertebral Body Cage was evaluated in accordance with FDA Document, Class II Special Controls, Guidance Document: Intervertebral Fusion Device, June 12, 2007, and has been found to meet criteria defined in the guidance document; and has been demonstrated to be substantially equivalent to predicate devices in terms of indications for use. function, materials, and performance (mechanical testing). Clinical data was not required for this device.

Company Confidential

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference of the circle. In the center of the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or feathers.

SEP 1 4 2009

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

Spinefrontier, Inc. % Mr. John Sullivan Director of OA and Regulatory Compliance 500 Cummings Center, Suite 3500 Beverly, Massachusetts 01915

Re: K091638

Trade/Device Name: Dorado™ Wide Intervertebral Body Cage Regulation Number: 21CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: MAX Dated: September 1, 2009 Received: September 3, 2009

Dear Mr. Sullivan:

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.

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 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.

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#### Page 2 - Mr. John Sullivan

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.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Daniel Keane

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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#### Indications for Use Statement 4:0

510(k) Number (if Known):

Indications For Use:

The DORADO™ Wide Intervertebral Body Cage is a spinal intervertebral body cade

intended for a posterior approach and uses autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous spinal levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolithesis at the involved level(s). The SpineFrontier DORADO™ Wide Intervertebral Body Cage is intended to be used with supplemental spinal fixation system(s) (Example: Posterior Pedicle Screw).

Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history or radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.

Prescription Use: X (Part 21 CFR 801 Subpart D)

ANDIOR

Over-The-Counter Use: (Part 21 CFR 807 Subpart C)

Daniel Krone for Nixon

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K091638

Company Confidential