SCIENT'X TRIBECA VBR

K080588 · Scient'X USA, Inc. · MAX · May 30, 2008 · Orthopedic

Device Facts

• Record ID: K080588
• Device Name: SCIENT'X TRIBECA VBR
• Applicant: Scient'X USA, Inc.
• Product Code: MAX · Orthopedic
• Decision Date: May 30, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3080
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Scient'x Tribeca™ Cage implants are indicated for use with autogenous bone graft as an intervertebral body fusion device at either one or two contiguous levels in the lumbosacral spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Tribeca™ Cage is to be used in skeletally mature patients who have had six months of non-operative care. The Tribeca™ Cage is implanted using an anterior or posterior approach and is intended to be used single or in pairs with ISOBAR ø6.2mm Hemispherical Screws with Offset Clamps and ø5.5mm Rods.

Device Story

Tribeca™ Cage is an intervertebral body fusion device designed for lumbar spinal stabilization. Manufactured from PEEK-OPTIMA polymer, the device is implanted by surgeons via anterior or posterior surgical approaches. It is intended for use with autogenous bone graft to facilitate fusion and must be used in conjunction with ISOBAR spinal fixation systems (hemispherical screws and rods). The device provides structural support to the intervertebral space, aiming to alleviate back pain associated with discogenic degeneration. It is intended for use in a clinical/surgical setting by qualified orthopedic or neurosurgeons.

Clinical Evidence

Bench testing only. Performance evaluated per ASTM F2077 and F2267 standards to demonstrate mechanical equivalence to predicate devices.

Technological Characteristics

Material: PEEK-OPTIMA polymer. Form factor: Lumbar interbody fusion cage. Standards: ASTM F2077, ASTM F2267. Sterilization: Provided non-sterile. Connectivity: None (mechanical device).

Indications for Use

Indicated for skeletally mature patients with degenerative disc disease (DDD) and up to Grade I spondylolisthesis at one or two contiguous levels (L2-S1) who failed six months of non-operative care.

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

• Abbott Spine Ardis Spacer (K073202)

Submission Summary (Full Text)

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MAY 30 2008

# 510(k) Summary

John Sanders Contact: Scient x USA Inc. 1015 Maitland Center Commons Suite 106 A Maitland, Florida 32751 407.571.2550 Tribeca™ Cage Device Trade Name: Scient'x USA Inc. Manufacturer: 1015 Maitland Center Commons Suite 106 A Maitland, Florida 32751 Intervertebral body fusion device Common Name: 21 CFR §888.3080 Classification: II Class: MAX Product Code:

#### Indications For Use:

The Scient'x Tribeca™ Cage implants are indicated for use with autogenous bone graft as an intervertebral body fusion device at either one or two contiguous levels in the lumbosacral spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Tribeca™ Cage is to be used in skeletally mature patients who have had six months of non-operative care.

The Tribeca™ Cage is implanted using an anterior or posterior approach and is intended to be used single or in pairs with ISOBAR ø6.2mm Hemispherical Screws with Offset Clamps and ø5.5mm Rods.

### Device Description:

The Tribeca™ Cage involves lumbar component spinal interbody fusion devices as well as instrumentation designed specifically for the implantation of these devices. The Tribeca™ Cage is manufactured from PEEK-OPTIMA polymer and is provided nonsterile.

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#### Predicate Device(s):

The Tribeca™ Cage was shown to be substantially equivalent to the Abbott Spine Ardis Spacer (K073202).

## Performance Standards:

Testing performed per ASTM F2077 and F2267 indicates the Tribeca Cage is substantially equivalent to predicate devices.

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Image /page/2/Picture/1 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the seal is a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Scient' X USA, Incorporated % Mr. John Sanders Quality Assurance Regulatory Affairs Manager 1015 Maitland Center Commons, Suite, 106A Maitland, Florida 32751

MAY 3 0 2008

K080588 Trade/Device Name: Scient' X Tribeca™ Cage Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: II Product Code: MAX Dated: March 10, 2008 Received: March 11, 2008

Dear Mr. Sanders:

Re:

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. Ilsting 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 such 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); 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 Sanders

This letter will allow you to begin marketing your device as described in your Scction 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Millerson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): KO80588

Device Name: Scient'x Tribeca™ Cage

The Scient'x Tribeca™ Cage implants are indicated for use with autogenous bone graft as an intervertebral body fusion device at either one or two contiguous levels in the lumbosacral spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Tribeca™ Cage is to be used in skeletally mature patients who have had six months of non-operative care.

The Tribeca™ Cage is implanted using an anterior or posterior approach and is intended to be used single or in pairs with ISOBAR ø6.2mm Hemispherical Screws with Offset Clamps and ø5.5mm Rods.

Prescription Use V (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)

| (Division Sign-Off) | |
|-----------------------------------|--|
| Division of General, Restorative, | |
| and Neurological Devices | |
| 510(k) Number | |