PILLAR PEDICLE SCREW SYSTEM

K071743 · The 4th Column, LLC · MNI · Jul 6, 2007 · Orthopedic

Device Facts

• Record ID: K071743
• Device Name: PILLAR PEDICLE SCREW SYSTEM
• Applicant: The 4th Column, LLC
• Product Code: MNI · Orthopedic
• Decision Date: Jul 6, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Pillar Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients undergoing fusion by autogenous bone grafting having implants attached to the lumbar and sacral spine with removal of implants after the attainment of a solid fusion. The Pillar Pedicle Screw System also is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spinc: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture. spinal stenosis, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis, and failed previous fusion.

Device Story

Internal spinal fixation system; consists of pedicle screws, rods, crosslinks, and set screws. Used by surgeons in spinal fusion procedures to provide immobilization and stabilization of thoracic, lumbar, and sacral segments. Components available in various lengths, diameters, and contours to match patient anatomy. Implants attached to spine to facilitate fusion via autogenous bone grafting; intended for removal after solid fusion attainment. Manual surgical instruments used for insertion/placement.

Clinical Evidence

bench testing only

Technological Characteristics

Internal spinal fixation system comprising pedicle screws, rods, crosslinks, and set screws. Components are available in various lengths, diameters, and contours. Mechanical fixation device; no energy source or software components.

Indications for Use

Indicated for skeletally mature patients requiring spinal fusion for severe spondylolisthesis (Grade 3-4) at L5-S1, or as an adjunct to fusion for acute/chronic instabilities or deformities of the thoracic, lumbar, and sacral spine, including degenerative spondylolisthesis with neurological impairment, fracture, spinal stenosis, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis, and failed previous fusion.

Regulatory Classification

Identification

(1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.

Special Controls

*Classification.* (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards; (ii) Compliance with mechanical testing standards; (iii) Compliance with biocompatibility standards; and (iv) Labeling that contains these two statements in addition to other appropriate labeling information: “Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.” “Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.” (2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls: (i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use. (ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant. (iii) Device components must be demonstrated to be biocompatible. (iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments. (v) Labeling must include the following: (A) A clear description of the technological features of the device including identification of device materials and the principles of device operation; (B) Intended use and indications for use, including levels of fixation; (C) Identification of magnetic resonance (MR) compatibility status; (D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and (E) Detailed instructions of each surgical step, including device removal. (3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls: (i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate. (ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.

Predicate Devices

• OPTIMA™ Spinal System (K031585)
• Moss Miami Spinal System (K982511, K983583, K955348)

Submission Summary (Full Text)

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510(k) Summary

Pillar Pedicle Screw

# 510(k) Summary

# The 4" Column, LLC Pillar Pedicle Screw System

JUL 26 2007

#### ADMINISTRATIVE INFORMATION

Sponsor Name:

The 4th Column, LLC 38 Avanzare Irvine, CA 92606 Telephone [phone] Fax [phone]

Official Contact:

Kevin Armstrong

Representative/Consultant:

David J. Collette, MD or Floyd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130 Telephone [phone] Fax [phone] Email: dcollette(@paxmed.com or flarson(@paxmed.com

## DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name: Common Name: Classification Names:

Pillar Pedicle Screw System Pedicle screw spinal system Orthosis, Spinal Pedicle Fixation; Orthosis Spondyloisthesis Spinal Fixation (21 CFR 888.3070), Class II MNI, MNH

Classification Regulation: Product Codes:

## ESTABLISHMENT REGISTRATION NUMBER

The 460 Column will submit Establishment Registration to IDA prior (o marketing the Pillar Pedicle Screw System.

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## INTENDED USE

The Pillar Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients undergoing fusion by autogenous bone grafting having implants attached to the lumbar and sacral spine with removal of implants after the attainment of a solid fusion.

The Pillar Pedicle Screw System also is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spinc: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture. spinal stenosis, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis, and failed previous fusion.

### DEVICE DESCRIPTION

The Pillar Pedicle Screw System is an internal fixation device for spinal surgery consisting of pedicle screws and rods that are interconnected using crosslinks and set screws. To chable close conformance to patient anatomy, pedicle screws and rods are available in various lengths, diameters, and/or contours. A series of manual surgical instruments (not a subject of this submission) intended to assist the insertion and placement of the implants are provided in an instrument tray.

## EQUIVALENCE TO MARKETED PRODUCT

The 410 Column demonstrated that, for the purposes of FDA s regulation of medical devices. the Pillar Pedicle Screw System is substantially equivalent in indications and design principles to the following preament devices: the OPTIMA™ Spinal System (K031585) from U&i Corporation, America and the Moss Miami Spinal System (K982511, K983583. K955348) from DePuy, Inc.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

The 4" Column, LLC % Paxmed International, LLC Mr. David Collette Regulatory Affairs 11234 El Camino Real, Suite 200 San Diego, California 92130

JUL 26 2007

K071743 Re:

> Trade/Device Name: Pillar Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNI, MNH Dated: June 22, 2007 Received: June 29, 2007

Dear Mr. Collette:

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.

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Page 2 – Mr. David Collette

This letter will allow you to begin marketing your device as described in your Section 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 Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrb/industry/support/index.html.

Sincerely vours.

Barbara Bulho

Mark N. Me 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):

Device Name: Pillar Pedicle Screw System

Indications for Use:

The Pillar Pedicle Screw System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebra in skeletally mature patients undergoing fusion by autogenous bone grafting having implants attached to the lumbar and sacral spine with removal of implants after the attainment of a solid fusion.

The Pillar Pedicle Screw System also is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment. Fractare spinal stenosis, dislocation, scoliosis, kyphosis, spinal tumor, pseudoarthrosis, and failed previous fusion.

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)

Barbare reehup for
(Division Sign-Off)rrence of CDRH, Office of Device Evaluation (ODE)
Division of General, Restorative,
and Neurological Devices