MODIFICATION TO TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM

K013829 · Medtronic Sofamor Danek, Inc. · MRW · Dec 19, 2001 · OR

Device Facts

• Record ID: K013829
• Device Name: MODIFICATION TO TOWNLEY TRANSFACETPEDICULAR SCREW FIXATION SYSTEM
• Applicant: Medtronic Sofamor Danek, Inc.
• Product Code: MRW · OR
• Decision Date: Dec 19, 2001
• Decision: SESE
• Submission Type: Special
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The TOWNLEY™ Transfacetpedicular Screw Fixation System is intended to stabilize the spine as an aid to fusion by two different fixation methods. The first fixation method uses the TOWNLEY™ Transfacetpedicular Screws as just facet fixation screws, where the screws are inserted bilaterally through the superior side of the facet, across the facet joint at (usually) a single level, and into the pedicle. In the second fixation method, the TOWNLEY™ Transfacetpedicular Screws are inserted bilaterally through the superior side of the facet, across the facet joint, and into the pedicle at multiple levels at the same time that a DYNALOK® Plate is attached to the base of the spinous processes at the corresponding levels with Transfacetpedicular Screws. The second fixation method should be used when the spine has increased instability or multiple levels need to be fused. Bone graft must be used for both fixation methods. For both methods, this system is indicated for the posterior surgical treatment of any or all of the following at the C2 to S1 (inclusive) spinal levels: 1) trauma, including spinal fractures and/or dislocations; 2) Spondylolisthesis; 3) Spondylolysis; 4) Pseudarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity; 5) Degenerative diseases which include: (a) degenerative disc disease (ddd) as defined by neck and/or back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or (b) degenerative disease of the facets with instability.

Device Story

TOWNLEY™ Transfacetpedicular Screw Fixation System consists of medical-grade stainless steel or titanium alloy screws designed to compress bone grafts. Used in posterior spinal surgery to stabilize spine at C2-S1 levels. Two fixation methods: 1) bilateral facet fixation screws inserted through superior facet across joint into pedicle; 2) multi-level fixation using screws combined with DYNALOK® spinous process plates. Operated by surgeons in OR. Provides mechanical stabilization to facilitate spinal fusion. Stainless steel and titanium components must not be mixed in same construct.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: Medical grade stainless steel (ASTM F-138, ISO 5832-1/9) or titanium alloy (ASTM F-136, ISO 5832-3). Components: Screws and optional DYNALOK plates. Mechanical fixation system.

Indications for Use

Indicated for posterior spinal stabilization (C2-S1) as an aid to fusion in patients with trauma (fractures/dislocations), spondylolisthesis, spondylolysis, pseudarthrosis/failed fusions, or degenerative disc/facet disease with instability. Requires bone graft.

Reference Devices

• DYNALOK® Plate

Submission Summary (Full Text)

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DEC 1 9 2001

Ko13829

### TOWNLEY™ Transfacetpedicular Screw Fixation System 510(k) Summary November 2001

- Medtronic Sofamor Danek USA, Inc. I. Company: 1800 Pyramid Place Memphis, TN 38132 [phone]
- Proprietary Trade Name: TOWNLEY™ Transfacetpedicular Screw Fixation System II.
- Product Descriptiom: The TOWNLEY™ Transfacetpedicular Screw Fixation System consists of III. screws designed to compress bone grafts. The screws are fabricated from medical grade stainless steel described by such standards as ASTM F-138 or ISO 5832-1 or ISO 5832-9, or titanium alloy conforming to such standards as ASTM F-136 or ISO 5832-3. The screws may be used with or without DYNALOK plates. DYNALOK plates are used as spinous process plates to connect two or more screws together on one side of the spine at the base of the spinous process when the system is used for the second fixation method described below. Stainless steel and titanium implant components should never be used in the same construct. The purpose of this submission is to add a 4.0mm titanium cortical bone screw to the system.
- Indications: The TOWNLEY™ Transfacetpedicular Screw Fixation System is intended to stabilize IV. the spine as an aid to fusion by two different fixation methods. The first fixation method uses the Transfacetpedicular Screws as just facet fixation screws, where the screws are inserted bilaterally through the superior side of the facet, across the facet joint at (usually) a single level, and into the pedicle.

In the second fixation method, the TOWNLEY™ Transfacetpedicular Screws are inserted bilaterally through the superior side of the facet, across the facet joint, and into the pedicle at multiple levels at the same time that a DYNALOK® Plate is attached to the base of the spinous processes at the corresponding levels with Transfacetpedicular Screws. The second fixation method should be used when the spine has increased instability or multiple levels need to be fused. Bone graft must be used for both fixation methods.

For both methods, this system is indicated for the posterior surgical treatment of any or all of the following at the C2 to S1 (inclusive) spinal levels: 1) rauma, including spinal fractures and/or dislocations; 2) Spondylolisthesis; 3) Spondylolysis; 4) Pseudarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity; 5) Degenerative diseases which include: (a) degenerative disc disease (ddd) as defined by neck and/or back pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or (b) degenerative disease of the facets with instability.

- Substantial Equivalence: Documentation was provided which demonstrated the TOWNLEY™ V. Transfacetpedicular Screw Fixation System to be substantially equivalent to itself.

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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# DEC 1 9 2001

Richard W. Treharne, Ph.D. Senior Vice President, Research and Regulatory Affairs Medtronic Sofamor Danek 1800 Pyramid Place Memphis, Tennessee 38132

Re: K013829

K013027
Trade/Device Name: TOWNLEY™ Transfacetpedicular Fixation System Product Code: MRW Dated: November 16, 2001 Received: November 19, 2001

Dear Dr. Treharne:

We have reviewed your Section 510(k) notification of intent to market the device We nave leviewed your bootion or susined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate comments indications for use stated in the eneround) it the Medical Device Amendments, or to prof to May 28, 1770, the charene and can es with the provisions of the Federal Food, devices mat nave been rochability in may, therefore, market the device, subject to the Drug, and Cosmetic Act (7tel). "Tou may) answeral controls provisions of the Act include general controls provisions of the Frida Stations 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 (Premarket Approval), it may be subject to such additional controls. Existing major (Fremarket Approvar), It may or saojoes for the Code of Federal Regulations, Title regulations articling your devivalent determination assumes compliance with 21, Falls 800 to 675. A substantially tigarequirement, as set forth in the Quality System
the current Good Manufacturing Practice requirement, as set forth and that the current Good Manafacturing Prasis. General regulation (21 CFR Part 820) and that, Regulation (QD) inspections, the Food and Drug Administration (FDA) will verify through periodic (QD) inspections, and the GMP regulation may result in regulatory Such assumptions. Funale to comply further announcements concerning your device in action: In addition, I Dlease note: this response to your premarket notification the recein Register. Treasonoter antion you might have under sections 531 through 542 Sublinssion act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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#### Page 2 - Richard W. Treharne, Ph.D.

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 tollfree number [phone] or at [phone], or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

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

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Page 1 of 1

000026

November 2001

510(k) Number (if known):

K013829

Device Name: TOWNLEY™ Transfacetpedicular Screw Fixation System

#### Indications for Use:

The TOWNLEY™ Transfacetpedicular Screw Fixation System is intended to stabilize the spine as an aid to fusion by two different fixation methods. The first fixation method uses the TOWNLEY™ to rastor of two arreless as just facet fixation screws, where the screws are inserted bilaterally through the superior side of the facet, across the facet joint at (usually) a single level, and into the pedicle.

In the second fixation method, the TOWNLEY™ Transfacetpedicular Screws are inserted bilaterally through the superior side of the facet, across the facet joint, and into the pedicle at multiple levels at the ttirough the bapers. Sico of a be is attached to the base of the spinous processes at the corresponding levels with Transfacetpedicular Screws. The second fixation method should be used when the spine has increased instability or multiple levels need to be fused. Bone graft must be used for both fixation methods.

For both methods, this system is indicated for the posterior surgical treatment of any or all of the r or other mountaly and 15 (inclusive) spinal levels: 1) Trauma, including spinal fractures and/or; dislocations; 2) Spondylolisthesis; 3) Spondylolysis; 4) Pseudarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity; 5) Degenerative diseases which include: (a) degenerative disc disease (ddd) as defined by neck and/or back pain of discogenic origin as monder. (d) acgetient history with degeneration of the disc as confirmed by radiographic studies and/or (b) degenerative disease of the facets with instability.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use (Per 21 CFR 801.109) | X |
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OR

| Over-The-Counter Use (Optional Format 1-2-96) | |
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| (Division Sign-Off) | |
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| Division of General, Restorative and Neurological Devices | |

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