VERTEBRON PSS PEDICLE SCREW SYSTEM

K051716 · Vertebron, Inc. · KWP · Sep 7, 2005 · Orthopedic

Device Facts

• Record ID: K051716
• Device Name: VERTEBRON PSS PEDICLE SCREW SYSTEM
• Applicant: Vertebron, Inc.
• Product Code: KWP · Orthopedic
• Decision Date: Sep 7, 2005
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The VERTEBRON PSS™ Pedicle Screw System is intended for noncervical, nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients. The VERTEBRON PSS™ Pedicle Screw System is intended for non cervical pedicle fixation for the following indications: spondylolisthesis (Grade 3 and 4 at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment); trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

Device Story

Vertebron PSS is a spinal fixation system consisting of titanium alloy rods, multi-axial and standard screws, hooks, locking caps, and cross connectors. Used by surgeons in clinical settings to stabilize the spine during bone graft fusion. System attaches to the vertebral body via screws to provide non-cervical fixation. This submission introduces 4.5mm standard and multi-axial screws to the existing product line. Device provides mechanical stabilization to the operative site, facilitating fusion and potentially reducing patient pain and disability associated with spinal pathologies.

Clinical Evidence

Bench testing only. Mechanical testing performed in accordance with ASTM F1717 to demonstrate substantial equivalence.

Technological Characteristics

Components: rods, multi-axial/standard screws, hooks, locking caps, cross connectors. Material: medical grade titanium alloy (ASTM F136). Non-sterile, single-use. Mechanical fixation via pedicle/interlaminal/intervertebral attachment.

Indications for Use

Indicated for skeletally mature patients requiring noncervical spinal fixation for degenerative disc disease, spondylolisthesis (including Grade 3/4 at L5-S1), trauma (fracture/dislocation), spinal stenosis, spinal curvatures (scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or failed previous fusion.

Regulatory Classification

Identification

A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.

Predicate Devices

• VERTEBRON PSS™ Pedicle Screw System (K033352)
• VERTEBRON PSS™ Pedicle Screw System (K043152)
• Optima Spinal Fixation System; U&I America (K024096)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the text "K051716 Page 1 of 2". The text appears to be handwritten in black ink on a white background. The text is slightly blurry, but still legible.

## VERTEBRON PSS™ Pedicle Screw System Special 510(k) Summary June 2005

## VIII. Summary of Safety and Effectiveness

- SUBMITTER: VERTEBRON Inc. 400 Long Beach Blvd. Stratford, CT 06615 [phone]
- CONTACT PERSON: Luis Nesprido Requlatory Affairs Manager

DATE PREPARED: June 2005

- CLASSIFICATION NAME: 21 CFR §888.3050 Spinal Interlaminal Fixation Orthosis 21 CFR §888.3060 Spinal Intervertebral Fixation Orthosis 21 CFR §888.3070 Pedicle Screw Spinal System
- COMMON NAME: Pedicle Screw Spinal System

PROPRIETARY NAME: VERTEBRON PSS™ Pedicle Screw System

- VERTEBRON PSS™ Pedicle Screw System K033352 & PREDICATE DEVICES: K043152
- DEVICE DESCRIPTION: The VERTEBRON PSS™ Pedicle Screw System is comprised of non-sterile, single use, titanium alloy components. The VERTEBRON PSS™ Pedicle Screw System attaches to the vertebral body by means of screws to the non-cervical spinal and allows a surgeon to build a spinal implant construct. This system's design is intended to stabilize the spinal operative site during the fusion process of a bone graft in the disc space. The VERTEBRON PSS™ Pedicle Screw System is made up of rods, multi-axial and standard screws, hooks, locking caps and both adjustable and fixed cross connectors. This submission adds 4.5mm Standard and MA Screws.
- The VERTEBRON PSS™ Pedicle Screw System is INTENDED USE: intended for noncervical, nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous

{1}------------------------------------------------

K051716
Page 2 of 2

fusion in skeletally mature patients. The VERTEBRON PSS™ Pedicle Screw System is intended for non cervical pedicle fixation for the following indications: spondylolisthesis (Grade 3 and 4 at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment); trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

MATERIALS: The material used is medical grade titanium material that conforms to ASTM F136.

## SUBSTANTIAL EQUIVALENCE:

Testing in accordance with ASTM F1717 was performed and demonstrated that the VERTEBRON PSS™ Pedicle Screw System 4.5mm Standard and MA Screws are substantially equivalent to the VERTEBRON PSS™ Pedicle Screw System (K033352 & K043152), and Optima Spinal Fixation System; U&I America (K024096), which have received market clearance by the FDA.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 7 2005

Mr. Luis Nesprido Manager, Regulatory Affairs VERTEBRON, Inc. 400 Long Beach Boulevard Stratford, Connecticut 06615

Re: K051716 Trade/Device Name: Vertebron PSSTM Pedicle Screw System Regulation Name: 21 CFR 888.3070(b)(1) Regulation Name: Pedicle screw spinal system, Spinal interlaminal fixation orthosis. Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: MNI, MNH, KWP, KWP, KWQ Dated: July 27, 2005 Received: August 9, 2005

Dear Mr. Nesprido:

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 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.

{3}------------------------------------------------

Page 2 - Mr. Luis Nesprido

This letter will allow you to begin marketing your device as described in your bection 5 0 local I ms letter will anow you to begin manketing your and equivalence of your device to a legally prematication. "The PDF maing of basification 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 If you desire specific advice for Jour at [phone]. Also, please note the regulation entitled, p Comati the Office of Compilance at (210) 216 Part 807.97). You may obtain
"Misbranding by reference to premarket notification" (21 CFR Part 807.97). Missuraling by reference to premainterial in the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Mark A. Wilkinson

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

Enclosure

{4}------------------------------------------------

## V. Indications for Use

510(k) Number (if known):

Device Name:

VERTEBRON PSS™ Pedicle Screw System

Indications For Use:

The VERTEBRON PSS™ Pedicle Screw System is intended for noncervical, nonpedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients. The VERTEBRON PSS™ Pedicle Screw System is intended for non cervical pedicle fixation for the following indications: spondylolisthesis (Grade 3 and 4 at L.5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment); trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion in skeletally mature patients.

Prescription Use: × AND / OR (Per 21 CFR 801 Subpart D)

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)

Mad. A. Milliken

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number