NV CORMED SOLAS SPINAL SYSTEM

K051959 · Nv Cormed · MNH · Oct 12, 2005 · Orthopedic

Device Facts

• Record ID: K051959
• Device Name: NV CORMED SOLAS SPINAL SYSTEM
• Applicant: Nv Cormed
• Product Code: MNH · Orthopedic
• Decision Date: Oct 12, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SOLAS™, Spinal System is a pedicle screw based spinal fixation system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 verebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (15 to sacrum) with removal of the implants after the attainment of a solid fusion. In addition, the SOLAS™ 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 the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal turnor and failed previous fusion (pseudoarthrosis). When used as an anterior screw fixation system or a posterior hook and sacral/iliac screw fixation system, the SOLAS™ is indicated for patients with degenerative disc disease which is defined as back pain of the discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, pseudoarthrosis, or revision of failed fusion attempts.

Device Story

SOLAS™ Spinal System is a top-loading anterior/posterior spinal fixation system; components include monoaxial and polyaxial pedicle screws, rods, set screws, connectors, and transverse linking mechanism. Used in thoracic, lumbar, and sacral spine for immobilization and stabilization as an adjunct to fusion. Operated by surgeons in clinical settings. Design allows adjustment in sagittal and coronal planes via preassembled washer in housing between screw and rod, tightened by set screw. Provides unilateral and bilateral fixation. Benefits patients by stabilizing spinal segments to facilitate fusion in cases of deformity, fracture, or degenerative disease. Instruments made of surgical grade stainless steel used for implantation/removal.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Titanium alloy (Ti-6Al-4V ELI) conforming to ASTM F 136. Components: Mono/polyaxial pedicle screws, rods, set screws, connectors, transverse links. Adjustment mechanism: Preassembled washer in housing for sagittal/coronal plane adjustment. Energy source: None (mechanical). Sterilization: Not specified.

Indications for Use

Indicated for skeletally mature patients requiring spinal fusion for severe spondylolisthesis (Grade 3-4) at L5-S1, or acute/chronic instabilities/deformities (degenerative spondylolisthesis, fracture, dislocation, scoliosis, kyphosis, tumor, pseudoarthrosis) of the thoracic, lumbar, and sacral spine. Also indicated for degenerative disc disease (discogenic back pain) when used as anterior or posterior hook/screw fixation system.

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.

Submission Summary (Full Text)

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

## OCT 1 2 2005

Confidential

## SUMMARY OF SAFETY AND EFFECTIVENESS

NV CORMED Sponsor: Aarschotsesteenweg 216 3130 Beqiinendijk BELGIUM

SOLAS™ Spinal System Device:

Classification Name: Pedicle Screw Spinal System (21CFR888.3070)

Intended Use: The SOLAS™, Spinal System is a pedicle screw based spinal fixation system indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 verebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (15 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition, the SOLAS™ 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 the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal turnor and failed previous fusion (pseudoarthrosis).

When used as an anterior screw fixation system or a posterior hook and sacral/iliac screw fixation system, the SOLAS™ is indicated for patients with degenerative disc disease which is defined as back pain of the discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal deformities such as scoliosis, kyphosis, lordosis, tumor, pseudoarthrosis, or revision of failed fusion attempts.

Device Description: The SOLAS™ Spinal System is a top-loading anterior / posterior spinal fixation system which consists of Mono and Polyaxial pedicle screws, rods, set screws, connectors, and a transverse (cross) linking mechanism. The SOLAS™ implant components are fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F 136. Various sizes of these implants are available.

The SOLAS'" Spinal system can be used in both the anterior and posterior planes providing unilateral and bilateral modes of fixation.

The SOLAS™ design allows adjustment in both the saggital and coronal planes permitting screw placement according to the best possible anatomic (spinal) location and orientation. This is accomplished by means of a preassembled washer in the housing component between the screw and the rod which tightens against the head of the pedicle screw upon connection of the set screw with the rod.

Specialized instruments made from surgical instrument grade stainless steel are available for the application and removal of the SOLASTM implants.

NV CORMED SOLAS™ Spinal System Premarket Notification

page lot of

Page-88

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

## (05/ 259

Potential Risks: The potential risks associated with this device are the same as with any spinal fixation device. These include, but are not limited to:

Blood vessel damage Deformity of the joint Cardiovascular disorders Component Failure Implant loosening/migration

Bone fracture Soft tissue complications Delayed wound healing Metal sensitivity Fracture of the components Nerve damage Infection Hematoma Nerve impingement Excessive wear

NV CORMED SOLAS™ Spinal System Premarket Notification

page 2 of L

Page-89

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in all capital letters.

Public Health Service

OCT 1 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NV CORMED c/o Carl Knobloch Turnkey Integration USA 5349 Red Leaf Court Oviedo, Florida 32756

Re: K051959

Trade/Device Name: SOLAS™ Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Code: MNI, MNH, KWQ Dated: July 17, 2005 Received: July 19, 2005

Dear Mr. Knobloch:

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- Carl Knobloch

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 prestleted 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 other general international and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

signature

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

Enclosure

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

## INDICATIONS FOR USE

510(k) Number (if known):

Device Name: CORMED NV , SOLAS™, Spinal System

Indications for Use: The CORMED NV , SOLAS™, Spinal System is a pedicle screw based spinal Indications for Use: The CORMED NV , SOLAS , Opilar Byttonis (Grade 3 and 4) of the LS-S1
fixation system indicated for the treatment of severe spondylolishess (Grade 3 a fixation system indicated for the treatinent of severe spenonomism (and managements)
vertebra in skeletally mature patients recurs of the implants affer the vertebra in skeletally mature patients receiving fusion by autogened of the implants after the attainment of a solid fusion.

In addition, the SOLAS™ is intended to provide immobilization of spinal segments in
telled in the intended to provide in the factures of the following acute and chronic ln addition, the SOLAS ™ Is intention in the treatment of the following acute and chronic
skeletally mature patients as an adjunct to huse and only doneerative soondylolisth skeletally mature patients as an adjurici to lustin in the secral ve spondyloisthesis
instabilities or deformities of the thoracic, numeral frestiga, diclosation, soninsis, s instabilities or deformities of the fiforacic, tutibal and subjection, scoliosis, kyphosis, spinal with Objective of previous fusion (pseudoarthrosis).

When used as an anterior system or a posterior hook and sacral/ilias screw fixation
ing the submit for the stimation in city descreative dise disease which is defined as When used as an anterior system of a potents with described incorded as a class which is defined as a system, the SOLAS™ is indicated for patients with degeneration of the discover on tradiographic
back pain of the discogenc origin with degeneration of the discovery as scolin back pain of the discogence origin will degeneration of the aronomies such as scollosis, kyphosis,
studies, spondylolisthesis, fracture, spinal stends in the effects as a sco studies, spondylolistifesis, fraotaro, opinal otof failed fusion attempts.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over the Counter Use _ (21 CFR 807 Subpart C)

్లు

(Please do not write below this line - continue on another page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number K051459

NV CORMED SOLAS™ Spinal System Premarket Notification