SURGICAL DYNAMICS RODDING SYSTEM (PREVIOUSLY KNOWN AS THE AURORA TITANIUM SPINAL ROD SYSTEM)

K983197 · United States Surgical, A Division of Tyco Healthc · KWP · Oct 26, 1998 · Orthopedic

Device Facts

• Record ID: K983197
• Device Name: SURGICAL DYNAMICS RODDING SYSTEM (PREVIOUSLY KNOWN AS THE AURORA TITANIUM SPINAL ROD SYSTEM)
• Applicant: United States Surgical, A Division of Tyco Healthc
• Product Code: KWP · Orthopedic
• Decision Date: Oct 26, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The components of the Surgical Dynamics Rodding System are indicated for spinal fixation. When used as an anterolateral/anterior system consisting of rods and screws, the levels of attachment are the lumbar, thoracic and cervical spine. The points of attachment and methods are screw fixation to the anterolateral vertebral bodies of the lumbar and thoracic spine (T6-L5) and the anterior vertebral bodies of the cervical spine. The indications are degenerative disc disease defined as back pain of discogenic origin with degeneration of the confirmed by history and radiographic studies, disc spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or failed previous fusion (pseudarthrosis). When used as a nonpedicle posterior system consisting of hooks, crosslinks and sacral/iliac screws the levels of attachment are the lumbar, thoracic and cervical spine and the sacrum and illium. Intended uses include hook and sacral screw fixation to the lumbar spine, noncervical spine and to the T1-S1 spine; and hook and sacral/iliac screw fixation to the noncervical spine. The indications are degenerative disc disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e. scoliosis, kyphosis, lordosis), turnors, pseudoarthrosis, or failed previous fusion (pseudarthrosis). When used as a pedicle screw system, in the non-cervical spine of skeletally mature patients, the SDRS 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 noncervical spine of skeletally mature patients, the SDRS 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

Surgical Dynamics Rodding System (SDRS) is a spinal fixation system comprising rods, screws, hooks, and crosslinks; used for immobilization and stabilization of spinal segments. System functions as an anterolateral/anterior system, nonpedicle posterior system, or pedicle screw system depending on configuration. Operated by surgeons in clinical settings to treat spinal instabilities, deformities, and degenerative conditions. Provides mechanical support to facilitate fusion; components are single-use. Surgeon selects appropriate configuration based on patient anatomy and pathology; device provides structural stabilization to the spine, potentially reducing pain and correcting deformities.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Implant grade wrought Titanium alloy (Ti-6Al-4V) conforming to ASTM F136 and ISO 5835/3. System includes rods, screws, hooks, and crosslinks. Single-use components. Cementless or cement fixation not applicable.

Indications for Use

Indicated for spinal fixation in patients with degenerative disc disease, spondylolisthesis, fracture, spinal stenosis, deformities (scoliosis, kyphosis, lordosis), tumors, pseudoarthrosis, or failed fusion. Pedicle screw use restricted to skeletally mature patients with severe spondylolisthesis (L5-S1) or acute/chronic instabilities (thoracic, lumbar, sacral) requiring immobilization/stabilization as an adjunct to fusion.

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

• Surgical Dynamics Rodding System (K970635)
• Surgical Dynamics Rodding System (K974213)
• Surgical Dynamics Rodding System (K974734)
• Surgical Dynamics Rodding System (K980862)

Submission Summary (Full Text)

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| OCT 26 1998 | Surgical Dynamics Rodding System | K983197<br>1of2 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| IX. | 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: | October 19, 1998 | |
| CLASSIFICATION NAME: | Spinal Intervertebral Body Fixation Orthosis<br>Spinal Interlaminal Fixation Orthosis<br>Spondylolisthesis Spinal Fixation Device System | |
| COMMON NAME: | Titanium Spinal Rod System | |
| PROPRIETARY NAME: | Surgical Dynamics Rodding System | |
| PREDICATE DEVICES: | USSC's Surgical Dynamics Rodding System - K970635,<br>K974213, K974734, K980862 (originally submitted as the<br>Aurora Titanium Spinal Rod System) | |
| INTENDED USE: | The components of the Surgical Dynamics Rodding System are<br>indicated for spinal fixation. | |

When used as an anterolateral/anterior system consisting of rods and screws, the levels of attachment are the lumbar, thoracic and cervical spine. The points of attachment and methods are screw fixation to the anterolateral vertebral bodies of the lumbar and thoracic spine (T6-L5) and the anterior vertebral bodies of the cervical spine. The indications are degenerative disc disease defined as back pain of discogenic origin with degeneration of the confirmed by history and radiographic studies, disc spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or failed previous fusion (pseudarthrosis).

When used as a nonpedicle posterior system consisting of hooks, crosslinks and sacral/iliac screws the levels of attachment are the lumbar, thoracic and cervical spine and the sacrum and illium. Intended uses include hook and sacral screw fixation to the lumbar spine, noncervical spine and to the T1-S1 spine; and hook and sacral/iliac screw fixation to the noncervical spine. The indications are degenerative disc disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e. scoliosis, kyphosis, lordosis), turnors, pseudoarthrosis, or failed previous fusion (pseudarthrosis).

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When used as a pedicle screw system, in the non-cervical spine of skeletally mature patients, the SDRS 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 noncervical spine of skeletally mature patients, the SDRS 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).

These device components are for single use. Cementless or cement fixation is not applicable to these components.

MATERIALS: The material used is implant grade material that conforms to ASTM F136 and ISO 5835/3 standards for wrought Titanium alloy (Ti-6Al-4V).]

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its wings. The eagle's head is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 6 1998

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

Re: K983197 Trade Name: Surgical Dynamics Rodding System Regulatory Class: II Product Codes: MNI, KWP, MHN, and KWQ Dated: September 9, 1998 September 11, 1998 Received:

Dear Ms. Murphy:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) 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 device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ಕ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, 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 In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification 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.

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#### Page 2 - Ms. Sharon L. Murphy

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 [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

Enclosure

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# Surgical Dynamics Rodding System

#### IV. Indications for Use

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

Surgical Dynamics Rodding System Device Name:

## Indications For Use:

The components of the Surgical Dynamics Rodding System are indicated for spinal fixation.

When used as an anterolateral/anterior system consisting of rods and screws, the levels of attachment are the lumbar, thoracic and cervical spine. The points of attachment and methods are screw fixation to the anterolateral bodies of the lumbar and thoracic spine (T6-L5) and the anterior vertebral bodies of the cervical spine. The indications are degenerative disc disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis, kyphosis, lordosis), tumor, pseudoarthrosis, or failed previous fusion (pseudarthrosis).

When used as a nonpedicle posterior system consisting of hooks, crosslinks and sacralliliac screws the levels of attachment are the lumbar, thoracic and cervical spine and the sacrum and ilium. Intended uses include hook and sacral screw fixation to the lumbar spine, noncervical spine and to the T1-S1 spine; and hook and sacral/iliac screw fixation to the noncervical spine. The indications are degenerative disc disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e. scoliosis, kyphosis, lordosis), tumors, pseudoarthrosis, or failed previous fusion (pseudarthrosis).

When used as a pedicle screw system, in the non-cervical spine of skeletally mature patients, the SDRS 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 SDRS is intended to provide immobilization and stabilization of spinal seqments, 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).

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use: | X | OR Over-The-Counter |
|----------------------|---|---------------------|
| Use: | | |
| (Per 21 CFR 801.109) | | |

| | (Division Sign-Off) |
|---------------|-----------------------------------------|
| | Division of General Restorative Devices |
| 510(k) Number | K9831 |