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The TOWNLEY Pedicle Screw Plating System is intended to stabilize the spine as an aid to fusion. After first making drill holes in the pedicles, a DYNA-LOK® plate is positioned of the pedicles. TOWNLEY Pedicle screws are then inserted through the DYNA-LOK® plate, down the center of the pedicles, and into the vertebral body. Bone graft must be used with each procedure.

This system is indicated for the treatment of any or all of the following at the C2 to S1 (inclusive) spinal levels: (a) Trauma, including spinal fractures and/or dislocations; (b) Spondylolisthesis; (c) Spondylolysis; (d) Pseudarthrosis or failed previous fusions which are symptomatic or which may cause secondary instability or deformity; (e) Degenerative disc disease and/or degenerative diseases which include: (1) degenerative disc disease (DDD) as defined by neck and/or back pain of discogenic origin as confirmed by radiographic studies; and/or (2) degenerative disease of the facets with instability.

This system consists of a broad-headed, partially threaded screw designed to compress bone grafts. Screw lengths range from 0.5 to 2.5 inches. Both cortical and cancellous screw threads are available. The screw comes in two configurations: flat-head or hex. The hex screws are wider in diameter. The stainless steel DYNA-LOK® plates are used to interconnect two or more vertebrae together via screw fixation through the pedicles. All components are fabricated from medical grade stainless steel (ASTM F-138 or its ISO equivalent). This 510(k) submission seeks to add 6.5mm diameter hex screws to the TOWNLEY Pedicle Screw Plating System.

This document describes the TOWNLEY Pedicle Screw Plating System, a medical device designed to stabilize the spine. It is a 510(k) summary submission, indicating that the manufacturer, Sofamor Danek, claims substantial equivalence to a predicate device already on the market.

Acceptance Criteria and Device Performance:

The document does not provide explicit acceptance criteria or a study demonstrating that the device meets such criteria. Instead, it details the device's description, indications for use, and a regulatory clearance letter from the FDA. The letter confirms "substantial equivalence" of the device system to previously marketed devices.

Table of Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) submission and not a study reporting performance against specific acceptance criteria, such a table cannot be directly generated from the provided text. The regulatory process relies on demonstrating equivalence to existing legally marketed devices, rather than establishing de novo performance metrics. The closest to "reported device performance" is the FDA's acceptance of its substantial equivalence for the specified indications.

The following information cannot be extracted from the provided text:

• Sample size used for the test set and the data provenance: No test set is described.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment for a test set is described.
• Adjudication method for the test set: No adjudication method is described.
• If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: No MRMC study or AI component is mentioned. This device is a mechanical implant, not an AI-assisted diagnostic or therapeutic tool.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is a medical implant, not an algorithm.
• The type of ground truth used: Not applicable as no specific study data or ground truth are discussed in relation to performance.
• The sample size for the training set: No training set is mentioned.
• How the ground truth for the training set was established: No training set is mentioned.

Summary of Device and Regulatory Clearance:

The TOWNLEY Pedicle Screw Plating System consists of broad-headed, partially threaded screws (ranging from 0.5 to 2.5 inches, with cortical and cancellous threads, and flat-head or hex configurations) and stainless steel DYNA-LOK® plates. The specific 510(k) submission seeks to add 6.5mm diameter hex screws to the existing system. All components are fabricated from medical grade stainless steel (ASTM F-138 or ISO equivalent).

Indications for Use (as cleared by FDA):

The system is intended to stabilize the spine as an aid to fusion, from C2 to S1 (inclusive) spinal levels. Bone graft must be used with each procedure.

The indications include:

• Trauma, including spinal fractures and/or dislocations.
• Spondylolisthesis (all grades and types).
• Spondylolysis.
• Pseudarthrosis or failed previous fusions which are symptomatic or may cause secondary instability or deformity.
• Degenerative disc disease and/or degenerative diseases, including:
  • Degenerative Disc Disease (DDD) as defined by neck and/or back pain of discogenic origin (confirmed by radiographic studies).
  • Degenerative disease of the facets with instability.

Substantial Equivalence:

The manufacturer submitted documentation asserting that the TOWNLEY Pedicle Screw Plating System is "substantially equivalent to itself," implying that the changes (addition of 6.5mm hex screws) do not alter the fundamental safety and effectiveness of the previously cleared system.

FDA Clearance (K982686):

The FDA reviewed the 510(k) submission and determined the device system is "substantially equivalent" for the stated indications. The FDA letter includes specific warnings and limitations on its use, emphasizing that pedicular screw fixation for other indications is considered investigational and requires an approved Premarket Approval (PMA) application. It also lists potential risks, including device component fracture, loss of fixation, non-union, vertebral fracture, neurological injury, and vascular or visceral injury.

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