THORACOLUMBAR SPINAL ROD SYSTEM (EMPOWER)

K983899 · United States Surgical, A Division of Tyco Healthc · KWQ · Dec 22, 1998 · Orthopedic

Device Facts

• Record ID: K983899
• Device Name: THORACOLUMBAR SPINAL ROD SYSTEM (EMPOWER)
• Applicant: United States Surgical, A Division of Tyco Healthc
• Product Code: KWQ · Orthopedic
• Decision Date: Dec 22, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3060
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Non-Pedicle Screw Fixation When used as an anterior spinal system the Thoracolumbar 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 Thoracolumbar 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 Thoracolumbar 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 Thoracolumbar 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 Thoracolumbar 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 Thoracolumbar 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

Thoracolumbar Spinal Rod System; stainless steel rods, interlaminal hooks, screws, crossbars. Used for spinal fixation/stabilization; anterior or posterior approach. Surgeon-operated in clinical/OR setting. Provides rigid construct to immobilize spinal segments; facilitates fusion. Benefits patient by stabilizing unstable segments; correcting deformities; treating degenerative conditions/fractures. Output is mechanical stabilization of spine.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Stainless steel rods, hooks, and screws conforming to ASTM F138. Mechanical fixation system. Non-cervical use. No software or energy source.

Indications for Use

Indicated for skeletally mature patients requiring spinal immobilization/stabilization as an adjunct to fusion for DDD, pseudoarthrosis, stenosis, deformities (scoliosis, kyphosis, lordosis), spondylolisthesis, fracture, dislocation, tumor, or failed previous fusion. Pedicle screw use restricted to L3-S1, severe L5-S1 spondylolisthesis (Grades 3-4), and autogenous bone graft. Non-cervical use only.

Regulatory Classification

Identification

A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.

Predicate Devices

• USSC's Surgical Dynamics™ Thoracolumbar Spinal Rod (Empower) System - K954696
• USSC's Surgical Dynamics™ Thoracolumbar Spinal Rod (Empower) System - K965224

Submission Summary (Full Text)

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| DEC-17-98 THU 11:36 AM REG CLIN AFFAIRS USSC | FAX NO. 5086432237 |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DEC 22 1998 | Thoracolumbar Spinal System |
| Summary of Safety and Effectiveness | |
| 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: | Thoracolumbar Spinal Rod System |
| PREDICATE DEVICES: | USSC's Surgical Dynamics™ Thoracolumbar Spinal Rod<br>(Empower) System - K954696, K965224 |
| DEVICE DESCRIPTION: | The Thoracolumbar Spinal Rod System consists of<br>stainless steel rods attached to the spinal column through<br>the use of interlaminal hooks and/or screws. Crossbars<br>may be used to connect rods to rods to provide a more<br>rigid construct, as well as screws to rods and hooks to<br>rods. |
| INTENDED USE: | Non-Pedicle Screw Fixation<br>When used as an anterior spinal system the<br>Thoracolumbar 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 Thoracolumbar Spinal Rod<br>System is limited to non-cervical use.<br><br>When used as a posterior, non-pedicle spinal system<br>(consisting of hooks and sacral/iliac screws), the<br>Thoracolumbar 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 Thoracolumbar Spinal Rod<br>System is limited to non-cervical use. |

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Thoracolumbar Spinal System

### Summary of Safety and Effectiveness

(continued)

## K483899 Page 2 of 2

Pedicle Screw Fixation INTENTED USE:

> When used as a pedicle screw system, in the spine of skeletally mature patients, the Thoracolumbar 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 Thoracolumbar 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).

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

United States Surgical Corporation Premarket Notification K983899/S2 Revised Summary of Safety and Effectiveness

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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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its body and wings.

DEC 22 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

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

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 requlations affecting your devices can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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 regulations.

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 diagnostic 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,

fcotte

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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Thoracolumbar Spinal System

# Indications for Use

510(k) Number (if known): K983899

Thoracolumbar Spinal Rod System Device Name:

### Indications For Use:

#### Non-Pedicle Screw Fixation

When used as an anterior spinal system the Thoracolumbar 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 Thoracolumbar Spinal Rod System is limited to non-cervical use.

When used as a posterior, non-pedicle spinal system (consisting of hooks and sacraliliac screws). the Thoracolumbar 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, kyohosis, lordosis), spondylolisthesis, fracture, previous failed fusion, or tumor resection. The Thoracolumbar 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 Thoracolumbar 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 Thoracolumbar 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 avidence of neurologic impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).

(Please do not write below this line - continue on another page if needed)
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 | K983899 |
|---------------|---------|
|---------------|---------|