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.

Device Description

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.

AI/ML Overview

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.

Summary

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Regulatory Affairs Department

Image /page/0/Picture/3 description: The image shows the logo for SOFAMOR DANEK. The logo consists of a pyramid-like shape on the left, followed by the words "SOFAMOR" on the top line and "DANEK" on the bottom line. The pyramid shape is made up of several horizontal lines that get progressively shorter as they go up, creating the illusion of a pyramid.

TOWNLEY Pedicle Screw Plating System 510(k) Summary

Sofamor Danek USA I. Company: 1800 Pvramid Place Memphis, TN 38132 (901) 396-3133

Proprietary Trade Name: TOWNLEY Pedicle Screw Plating System II.

III. Product Description

IV. Indications

V. Substantial Equivalence

Documentation was provided which demonstrated the TOWNLEY Pedicle Screw Plating System was demonstrated to be substantially equivalent to itself.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 7 1998

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

Re: K982686 Townley Pedicle Screw Plating System Regulatory Class: II Product Codes: MNI, MNH and KWP Dated: July 30, 1998 Received: August 3, 1998

Dear Dr. Treharne:

We have reviewed your Section 510(k) notification of intent to market the device system referenced above and we have determined the device system is substantially equivalent (for the indications for use stated in the enclosure) to device systems marketed in interstate commerce prior to May 28, 1976 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 your device system subject to the general controls provisions of the Act and the limitations identified below. 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. Note that labeling or otherwise promoting this device system for pedicular screw fixation/attachment for indications other than that described in item 2 below, would cause the device system to be adulterated under 501(f)(1) of the Act.

This device system, when intended for pedicular screw fixation/attachment to the spine for indications other than that described in item 2 below, is a class III device under Section 513(f) of the Act. Class III devices are required to have an approved premarket approval (PMA) application prior to marketing. Accordingly

1. The package label must state that there are labeling limitations.
1. The package insert must prominently state that the device system, as a pedicle screw fixation system, is intended only for the following:

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

trauma, including fractures and/or dislocations; a.
degenerative disc disease and/or degenerative diseases which include: b.
- degenerative disc disease (ddd) as defined by back and/or neck pain of (1) discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or
- degenerative disease of the facets with instability; (2)
spondylolysis; C.
spondylolisthesis, all grades and types; and d.
pseudarthrosis. e.

For all of these indications, bone graft must be used and the system is limited to screw fixation from C2 to S1; and

1. The package insert must also include the following WARNINGS:
- As a pedicle screw fixation system, this subject system is intended only for the following:
  - trauma, including fractures and/or dislocations;
  - degenerative disc disease and/or degenerative diseases which include:
    - (1) degenerative disc disease (ddd) as defined by back and/or neck pain of discogenic origin as confirmed by patient history with degeneration of the disc as confirmed by radiographic studies and/or
    - (2) degenerative disease of the facets with instability;
  - spondylolysis;
  - spondylolisthesis, all grades and types: and
  - pseudarthrosis.

For all of these indications, bone graft must be used and the system is limited to screw fixation from C2 to S1.

Benefit of spinal fusions utilizing any pedicle screw fixation system has not been adequately established in patients with stable spines.
Potential risks identified with the use of this device system, which may . require additional surgery, include: device component fracture, loss of

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fixation, non-union, fracture of the vertebra, neurological injury, and vascular or visceral injury.

See Warnings, Precautions, and Potential Adverse Events sections of the package insert for a complete list of potential risks.

Any pedicular screw fixation/attachment for intended uses other than that described 4. by item 2 above, for this device is considered investigational and may only be investigated as a significant risk device in accordance with the investigational device exemption (IDE) regulations under 21 CFR, Part 812. All users of the device for pedicular screw fixation/attachment for intended uses other than that described above, must receive approval from their respective institutional review boards (IRBs) and the Food and Drug Administration (FDA) prior to conducting an investigation.
న్. Any previous warning statements identified as part of previous 510(k) clearances or required by OC/Labeling and Promotion which stated that a component/system was not approved for screw fixation into the pedicles of the spine must be replaced by the warnings of item 3 above.

FDA advises that the use of your device system with any other device components but those identified in this 510(k) would require submission of a new 510(k) providing documentation of design, material, and labeling compatibility between the device components. Mechanical testing of a spinal system consisting of the subject device components and other device components, whether yours or those of other manufacturers, may also be required.

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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A 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 regulation (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 action. In addition, FDA may publish further announcements 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.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification immediately. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and 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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket

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Page 4 - Richard W. Treharne, Ph.D.

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 (800) 638-2041 or at (301) 443-6597, 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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510(k) Number (if known): K982686

TOWNLEY Pedicle Screw Plating System Device Name:

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109) (Optional 1-2-96)

Over-the-counter Use _________________________________________________________________________________________________________________________________________________________

Division Sign-Off

(Division Sign-Off) Division of General Restorative Devices 510(k) Number_k982686

Regulation Number and Section

N/A