ROGOZINSKI SPINAL ROD SYSTEM

K983904 · United States Surgical, A Division of Tyco Healthc · KWP · Dec 22, 1998 · Orthopedic

Device Facts

• Record ID: K983904
• Device Name: ROGOZINSKI SPINAL ROD SYSTEM
• Applicant: United States Surgical, A Division of Tyco Healthc
• Product Code: KWP · Orthopedic
• Decision Date: Dec 22, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Non-Pedicle Screw Fixation When used as an anterior spinal system the Rogozinski Spinal Rod System is intended for the treatement of DDD (degenerative disc disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history or radiographic studies), pseudoarthrosis, stenosis, deformities (scoliosis, kyphosis, lordosis), spondylolisthesis, fracture, previous failed fusion, or tumor resection. The Rogozinski Spinal Rod System is limited to non-cervical use. When used as a posterior, non-pedicle spinal system (consisting of hooks and sacral/iliac screws), the Rogozinski Spinal Rod System is intended for the treatement of DDD (degenerative disc disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history or radiographic studies), pseudoarthrosis, stenosis, deformities (scoliosis, kyphosis, lordosis), spondylolisthesis, fracture, previous failed fusion, or tumor resection. The Rogozinski Spinal Rod System is limited to non-cervical use. Pedicle Screw Fixation When used as a pedicle screw system, in the spine of skeletally mature patients, the Rogozinski Spinal Rod System is indicated for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass. In addition, when used as a pedicle screw system, in the non-cervical spine of skeletally mature patients, the Rogozinski Spinal Rod System is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in the treatment of the following acute and chronic instabilities of the thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

Device Story

Spinal rod system for surgical stabilization; consists of stainless steel rods, interlaminal hooks, and screws. Crossbars provide rigid construct. Used in anterior or posterior spinal procedures to treat instabilities, deformities, and degenerative conditions. Implanted by surgeons in clinical/OR settings. Provides mechanical immobilization of spinal segments to facilitate fusion. Benefits patients by stabilizing spine, correcting deformities, and addressing chronic/acute instabilities.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, material, and intended use similarity to predicate devices.

Technological Characteristics

Stainless steel implants conforming to ASTM F138. System includes rods, interlaminal hooks, sacral/iliac screws, and crossbars. Mechanical fixation device; non-powered.

Indications for Use

Indicated for skeletally mature patients requiring spinal immobilization/stabilization as an adjunct to fusion. Conditions: severe spondylolisthesis (L5-S1), degenerative disc disease, pseudoarthrosis, stenosis, deformities (scoliosis, kyphosis, lordosis), fracture, dislocation, spinal tumor, failed previous fusion. Restricted to non-cervical spine; pedicle screw use limited to L3 and below with autogenous bone graft.

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

• USSC's Surgical Dynamics™ Rogozinski Spinal Rod System (K884263, K896106, K930298, K950865, K954696, K965224)

Submission Summary (Full Text)

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| DEC 22 1998 | Rogozinski Spinal System<br>Summary of Safety and Effectiveness | | K983904<br>page 1 of 2 |
|-------------|-----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| | SUBMITTER: | United States Surgical Corporation<br>150 Glover Avenue<br>Norwalk, CT 06856 | |
| | CONTACT PERSON: | Sharon L. Murphy | |
| | DATE PREPARED: | September 29, 1998 | |
| | CLASSIFICATION NAME: | Spinal Intervertebral Body Fixation Orthosis<br>Spinal Interlaminal Fixation Orthosis<br>Spondylolisthesis Spinal Fixation Device System | |
| | COMMON NAME: | Spinal Rod System | |
| | PROPRIETARY NAME: | Rogozinski Spinal Rod System | |
| | PREDICATE DEVICES: | USSC's Surgical Dynamics™ Rogozinski Spinal Rod<br>System - K884263, K896106, K930298, K950865,<br>K954696, K965224 | |
| | DEVICE DESCRIPTION: | The Rogozinski Spinal Rod System consists of stainless<br>steel rods attached to the spinal column through the use of<br>interlaminal hooks and/or screws. Crossbars may be used<br>to connect rods to rods to provide a more rigid construct,<br>as well as screws to rods and hooks to rods. | |
| | INTENDED USE: | Non-Pedicle Screw Fixation | |
| | | When used as an anterior spinal system the Rogozinski<br>Spinal Rod System is intended for the treatement of DDD<br>(degenerative disc disease defined as back pain of<br>discogenic origin with degeneration of the disc confirmed<br>by history or radiographic studies), pseudoarthrosis,<br>stenosis, deformities (scoliosis, kyphosis, lordosis),<br>spondylolisthesis, fracture, previous failed fusion, or tumor<br>resection. The Rogozinski Spinal Rod System is limited to<br>non-cervical use. | |
| | | When used as a posterior, non-pedicle spinal system<br>(consisting of hooks and sacral/iliac screws), the<br>Rogozinski Spinal Rod System is intended for the<br>treatement of DDD (degenerative disc disease defined as<br>back pain of discogenic origin with degeneration of the<br>disc confirmed by history or radiographic studies),<br>pseudoarthrosis, stenosis, deformities (scoliosis, kyphosis,<br>lordosis), spondylolisthesis, fracture, previous failed fusion,<br>or tumor resection. The Rogozinski Spinal Rod System is<br>limited to non-cervical use. | |

10/11/2

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# Surnmary of Safety and Effectiveness

# K983906 Page 2 of 2

#### Pedicle Screw Fixation INTENDED USE :

When used as a pedicle screw system, in the spine of (continued) skeletally mature patients, the Rogozinski Spinal Rod System is indicated for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.

> In addition, when used as a pedicle screw system, in the non-cervical spine of skeletally mature patients, the Rogozinski Spinal Rod System is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in the treatment of the following acute and chronic instabilities of the thoracic, lumbar, and sacral degenerative spondylolisthesis with objective spine: evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

MATERIALS: The material used is implant grade material that conforms to ASTM F138 standards for stainless steel.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them, resembling a bird or a symbol of human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 22 1998

Ms. Sharon L. Murphy Regulatory Affairs Program Manager United States Surgical Corporation 150 Glover Avenue Norwalk, Connecticut 06856

K983899 Re : Thoracolumbar Spinal Rod System (Empower) Trade Name: K983904 Roqozinski Spinal Rod System Trade Name: Requlatory Class: II Product Codes: MNI, MNH, KWQ, and KWP October 30, 1998 Dated: November 3, 1998 Received:

Dear Ms. Murphy:

We have reviewed your Section 510(k) notifications of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosures) to 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). You may, therefore, market the devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submission does

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Page 2 - Ms. Sharon L. Murphy

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 requlations.

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

If you desire specific advice for your devices on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your devices, 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 [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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

Enclosures

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Rogozinski Spinal System

# Indications for Use

510(k) Number (if known): K983904

Rogozinski Spinal Rod System Device Name:

Indications For Use:

# Non-Pedicle Screw Fixation

When used as an anterior spinal system the Rogozinski Spinal Rod System is intended for the treatement of DDD (degenerative disc disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history or radiographic studies), pseudoarthrosis, stenosis, deformities (scollosis, kyphosis), spondylolisthesis, fracture, previous failed fusion, or tumor resection. The Rogozinski Spinal Rod System is limited to non-cervical use.

When used as a posterior, non-pedicle spinal system (consisting of hooks and sacral/iliac screws), the Rogozinski Spinal Rod System is intended for the treatement of DDD (degenerative disc disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history or radiographic studies), pseudoarthrosis, deformities (scoliosis, kyphosis, lordosis), spondylolisthesis, fracture, previous failed fusion, or tumor resection. The Rogozinski Spinal Rod System is limited to non-cervical use.

#### Pedicle Screw Fixation

When used as a pedicle screw system, in the spine of skeletally mature patients, the Rogozinski Spinal Rod System is indicated for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the LS-S1 igint: (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.

In addition, when used as a pedicle screw system, in the non-cervical spine of skeletally mature patients, the Rogozinski Spinal Rod System is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in the treatment of the following acute and chronic instabilities of the thoracic, lumbar, and sacral spine. degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).

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| | Concurrence of CDRH, Office of Device Evaluation (ODE) |
|------------------------------|--------------------------------------------------------|
| Prescription Use: | X |
| | OR Over-The-Counter |
| Use:<br>(Per 21 CFR 801.109) | |

(Division Sign-Off)

Division of General Restorative Devices

510(k) Number K983904
A1