ISOBAR SPINAL SYSTEM

K013447 · Scien'Tx USA, Inc. · KWP · Jan 15, 2002 · Orthopedic

Device Facts

• Record ID: K013447
• Device Name: ISOBAR SPINAL SYSTEM
• Applicant: Scien'Tx USA, Inc.
• Product Code: KWP · Orthopedic
• Decision Date: Jan 15, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ISOBAR Spinal System is a pedicle screw system 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, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). As a pedicle screw system, the ISOBAR Spinal System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion. When used as a posterior, non-cervical, non-pedicle screw fixation system, the ISOBAR Spinal System is intended for hook fixation from T1 to the ilium/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by history patient history and radiographic studies), deformities (scoliosis, kyphosis and lordosis), tumor, pseudoarthrosis, trauma (fracture or dislocation) and/or previous failed fusion surgery.

Device Story

ISOBAR Spinal System comprises pedicle screws, rods, nuts, crosslink members, and hooks; provides spinal segment immobilization and stabilization. Used as adjunct to fusion for acute/chronic instabilities or deformities of thoracic, lumbar, and sacral spine. Implanted by surgeons in clinical settings. System components provide mechanical fixation to stabilize vertebrae; supports bone graft healing. Benefits include stabilization of spinal segments in patients with severe deformities or degenerative conditions.

Clinical Evidence

No clinical data. Bench testing only; static and fatigue compression testing performed per ASTM F1717-96.

Technological Characteristics

Components manufactured from titanium alloy (Ti-6Al-4V) conforming to ASTM F136. System includes pedicle screws, rods, nuts, crosslink members, and hooks. Mechanical fixation device.

Indications for Use

Indicated for skeletally mature patients requiring spinal immobilization/stabilization as an adjunct to fusion. Treats thoracic, lumbar, and sacral spine conditions: degenerative spondylolisthesis with neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed fusion (pseudarthrosis), severe spondylolisthesis (Grade 3-4 at L5-S1), and degenerative disc disease.

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

• TSRH Spinal Implant System (K982990)
• ISOLA Spinal System (K980485)

Submission Summary (Full Text)

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

### 510(k) Summary of Safety and Effectiveness JAN 1 5 2002

Submitter's name: (1) Submitter's address: Contact telephone number: Contact person: Date summary prepared:

Common or usual name:

Classification name:

(2)

Scient'x Guvancourt, France [phone] Joanna Droege October 8, 2001

K013447
page 1 of 1

ISOBAR Spinal System Additional Components Trade or proprietary device name: Pedicle screw spinal system Class II

- TSRHTM Spinal Implant System (K982990) Sofamor Legally marketed predicate device: (3) Danek and the ISOLA® Spinal System (K980485) DePuy AcroMed.
#### (4) Subject device description:

The ISOBAR Spinal System consists of pedicle screws, rods, nuts, crosslink members and hooks. It can be used for single or multiple level fixation. All components are manufactured from titanium alloy (Ti-6Al-4V) that conforms to ASTM F136.

#### Subject device intended use: (ર)

The ISOBAR Spinal System is a pedicle screw system 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, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion fracture. (pseudarthrosis).

As a pedicle screw system, the ISOBAR Spinal System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the ISOBAR Spinal System is intended for hook fixation from T1 to the ilium/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by history patient history and radiographic studies), deformities (scoliosis and lordosis), tumor, pseudoarthrosis, trauma (fracture or dislocation) and/or previous failed fusion surgery.

#### (6) Performance data:

The Food and Drug Administration have established no performance standards applicable to pedicle screw spinal systems. However, static and fatigue compression testing was performed according to ASTM F1717-96.

#### (7) Basis for substantial equivalence:

The ISOBAR Spinal System hook components are similar in design, materials and indications as the TSRH™ Spinal Implant System (K982990) Sofamor Danek and the ISOLA® Spinal System (K980485) DePuy AcroMed.

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

Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is an image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 5 2002

Scient'X c/o Ms. Joanna Droege Regulatory/QA Manager Encore Orthopedics 9800 Metric Boulevard Austin, Texas 78758

K013447 Re:

Trade Name: ISOBAR Spinal System Regulatory Number: 21 CFR 888.3070, 21 CFR 888.3070, 21 CFR 888.3050 Regulation Name: Pedicle Screw Spinal System, Spondylolisthesis Spinal Fixation Device System, Spinal Interlaminal Fixation Orthosis, Regulatory Class: II Product Code: MNH, MNI, KWP Dated: October 15, 2001 Received: October 17, 2001

Dear Ms. Droege:

We have reviewed your Section 510(k) notification of intent to market the device referenced We have have determined the device is substantially equivalent (for the indications for use above and we nave determined an marketed in interstate commerce prior to May 28, 1976, the stated in the encrosure) to device Amendments, or to devices that have been reclassified in enacificin date of the Modical Doviet Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general therefore, market the act received to equirements for annual registration, listing of devices, Controls provisions of the heading, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations (1 Child Kel Approvar), it may of Sallery of Federal Regulations, Title 21, Parts 800 to allecting your device can or route entination assumes compliance with the current Good 097. A substainmin'y equirement, as set forth in the Quality System Regulation (QS) for Manufacturing Praction regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to mspections, the Food and Drag result in regulatory action. In addition, FDA may publish comply with the Grill regarenting your device in the Federal Register. Please note: this response to your premarks contrise your submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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

Page 2 - Ms. Joanna Droege

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Ro. Mark n. Millman

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

510(k) Number (if known): _((_________________________________________________________________________________________________________________________________________________

K013447

Device Name: ISOBAR Spinal System Additional Components

XO13447
page 1 of 1

Indications For Use:

# ISOBAR Spinal System Additional Components

## Indications For Use

System is a pedicle screw system intended to provide The ISOBAR Spinal 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, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

As a pedicle screw system, the ISOBAR Spinal System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the ISOBAR Spinal System is intended for hook fixation from T1 to the ilium/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by history patient history and radiographic studies), deformities (scoliosis, kyphosis and lordosis), tumor, pseudoarthrosis, trauma (fracture or dislocation) and/or previous failed fusion surgery.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE (F NEEDED)

Concurrerice of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number K013447
Prescription Use X OR Over-The-Counter Use *_
(per 21 CFR 801.109)
(Optional Format 1-2-96)*_