Predicate Devices

Not Found

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use clearly describe a mechanical spinal fixation system made of metal components. There is no mention of software, algorithms, or any features that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".

Therapeutic

Yes.
The device is described as "intended to stabilize the spine as an aid to fusion" and 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, all grades and types, (c) Spondylolysis, (d) Pseudarthrosis, (e) Degenerative disc disease and/or degenerative diseases". These are all medical conditions that the device aims to treat or alleviate, fitting the definition of a therapeutic device.

Diagnostic

No

This device is a surgical implant (pedicle screw plating system) designed to stabilize the spine and aid in fusion, not to diagnose a condition.

SaMD (Software as a Medical Device)

No

The device description clearly states it consists of physical components like screws and plates made of titanium alloy or stainless steel, which are hardware.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body.
Device Description and Intended Use: The provided text clearly describes a surgical implant system used to stabilize the spine within the body. It involves screws and plates inserted into the pedicles of vertebrae.
Lack of Specimen Testing: There is no mention of collecting or testing any biological specimens from the patient.

The TOWNLEY Pedicle Screw Plating System is a surgical implant, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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 over the pedicles. TOWNLEY Pedicle screws are then inserted through the 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, all grades and types, (c) Spondylolysis, (d) Pseudarthrosis, (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 patient history with degeneration of the disc as confirmed by radiographic studies and/or (2) degenerative disease of the facets with instability.

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

Product codes

MNI, MNH, KWP

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 DYNA-LOK® plates are used to interconnect two or more vertebrae together via screw fixation through the pedicles. The components are made of titanium alloy such as described by ASTM F-136. or ISO 5832-3. Alternatively, the entire system may be made out of medical grade stainless steel such as described by ASTM F-138 or ISO 5832-1 or ISO 5832-9. This 510(k) submission seeks to add the titanium alloy components to the TOWNLEY Pedicle Screw Plating System.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

C2 to S1 (inclusive) spinal levels

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Not Found

Key Metrics

Not Found

Predicate Device(s)

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

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
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.(b)
Classification. Class II.

Summary

0

NOV 1 2 1998

TOWNLEY Pedicle Screw Plating System 510(k) Summary November 4th, 1998

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

II. Proprietary Trade Name: TOWNLEY Pedicle Screw Plating System

Product Description III.

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 DYNA-LOK® plates are used to interconnect two or more vertebrae together via screw fixation through the pedicles. The components are made of titanium alloy such as described by ASTM F-136. or ISO 5832-3. Alternatively, the entire system may be made out of medical grade stainless steel such as described by ASTM F-138 or ISO 5832-1 or ISO 5832-9. This 510(k) submission seeks to add the titanium alloy components to the TOWNLEY Pedicle Screw Plating System.

IV. Indications

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 over the pedicles. TOWNLEY Pedicle screws are then inserted through the 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, all grades and types, (c) Spondylolysis, (d) Pseudarthrosis, (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 patient history with degeneration of the disc as confirmed by radiographic studies and/or (2) degenerative disease of the facets with instability.

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

V. Substantial Equivalence

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

1

Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract symbol resembling a bird in flight, composed of three curved lines. The symbol is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". The text is arranged around the circumference of the circle.

NOV 1 2 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K983706 Townley Pedicle Screw Plating System Regulatory Class: II Product Codes: MNI, MNH, and KWP October 20, 1998 Dated: Received: October 21, 1998

Dear Dr. Treharne:

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 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 requlations 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 Requlation (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 requlation 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.

2

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 requlation (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 notification" (21 CFR 807.97). Other genera 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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

tcoelke

Cella M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

3

510(k) Number (if known): Jeg 8370 6

TOWNLEY Pedicle Screw Plating System Device Name:_

Indications for Use:

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 over the pedicles. TOWNLEY Pedicle screws are then inserted through the 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, all grades and types, (c) Spondylolysis, (d) Pseudarthrosis, (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 patient history with degeneration of the disc as confirmed by radiographic studies and/or (2) degenerative disease of the facets with instability.

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

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

Concurrence of CDRH, Office of Evaluation (ODE)

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

OR

Over-the-counter Use

c

(Division Sign-Off)
Division of General Restorative Devices K983706
510(k) Number. 000021