TOWNLEY FACET/PEDICULAR SCREW PLATING SYSTEM

K953076 · Sofamor Danek USA,Inc. · MRW · Feb 28, 1997 · OR

Device Facts

• Record ID: K953076
• Device Name: TOWNLEY FACET/PEDICULAR SCREW PLATING SYSTEM
• Applicant: Sofamor Danek USA,Inc.
• Product Code: MRW · OR
• Decision Date: Feb 28, 1997
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The 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 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 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 DYNA-LOK® 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. 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

System comprises broad-headed, partially threaded screws (cortical/cancellous threads) and DYNA-LOK® spinous process plates; used for posterior spinal stabilization as an aid to fusion. Two fixation methods: 1) bilateral facet-to-pedicle screw insertion; 2) bilateral facet-to-pedicle screw insertion combined with spinous process plates. Requires bone graft. Used in surgical settings by orthopedic or neurosurgeons. Provides mechanical stabilization to facilitate spinal fusion in trauma, degenerative, or instability cases.

Clinical Evidence

No clinical data provided; substantial equivalence based on literature and documentation.

Technological Characteristics

Components fabricated from medical grade stainless steel (ASTM F-138 or ISO equivalent). System includes broad-headed, partially threaded screws and spinous process plates. Mechanical fixation device; no energy source or software.

Indications for Use

Indicated for posterior spinal stabilization as an aid to fusion in patients C2-S1 requiring treatment for trauma (fractures/dislocations), spondylolisthesis, spondylolysis, pseudarthrosis, failed previous fusions, or degenerative diseases (discogenic pain/facet instability).

Submission Summary (Full Text)

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K953076

# RELEASABLE SUMMARY OF SAFETY AND EFFECTIVENESS
## TRANSFACETPEDICULAR SCREW FIXATION SYSTEM
### K953076
#### February 19, 1997

FEB 28 1997

I. **Company**: Sofamor Danek USA
1800 Pyramid Place
Memphis, TN 38132
[phone]

II. **Proprietary Trade Name**: TRANSFACETPEDICULAR Screw Fixation System

III. This system consists of a broad-headed, partially threaded screw designed to compress bone grafts. Both cortical and cancellous screw threads are available. The stainless steel DYNA-LOK® 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 processes when the system is used for the second fixation method described below. All components are fabricated from medical grade stainless steel (ASTM F-138 or its ISO equivalent).

IV. **Indications**: The 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 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 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 DYNA-LOK® 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.

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.

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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.

V. Literature and other documentation concerning this device system were supplied in support of establishing a claim of substantial equivalence and the preamendment status of a predicate device system.

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