When properly used, this system will provide temporary stabilization until a solid spinal fusion develops. This system is intended for use only in the thoracic, lumbar and sacral levels of the spine. This system is not for use in the cervical spine. Specific indications include:

Degenerative Disc Disease (DDD as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies).
Pseudoarthrosis.
Stenosis
Spondylolisthesis.
Spinal deformities such as scoliosis and lordosis.
Fracture.
Unsuccessful previous fusion surgery.
Tumor resection.

Device Description

The MSD WIRE System construct consists of rods and segmental sublaminal wiring, being pre-formed and put in place by simple, commonly used, instrumentation. The purpose of this submission is to change the name of the system to the MSD WIRE System and to add previously cleared rods to the MSD WIRE System. The implant components are made of stainless steel as described by ASTM Standard F138 or ISO 5832-1. Stainless steel and titanium implant components must not be used together in a construct.

AI/ML Overview

The provided text describes the 510(k) summary for the Medtronic Sofamor Danek MSD WIRE System. It is focused on regulatory clearance based on substantial equivalence to a predicate device and does not contain information about the performance of a device based on specific acceptance criteria from a study.

Therefore, I cannot provide the requested information in the format of acceptance criteria and device performance based on a study, as the document does not contain this type of data.

Here's why the prompt cannot be fully answered with the given text:

No acceptance criteria or study details: The 510(k) summary is a regulatory document to demonstrate equivalence, not a clinical study report that would outline acceptance criteria, reported device performance, sample sizes, expert qualifications, or ground truth establishment.
Focus on substantial equivalence: The core conclusion of this document is that the MSD WIRE System is "substantially equivalent to the original ORFIL Spine Fixation System (K934007)." This indicates a comparison to a previously cleared device, not a de novo study with performance metrics against pre-defined criteria.
Functionality & Safety Testing: The document mentions "A Risk Analysis was performed on the MSD WIRE System and was included in this submission." While this is a safety activity, it's not a performance study with quantitative acceptance criteria as would be expected for a diagnostic or AI-driven device.

In summary, the provided document is a regulatory submission for device clearance and does not contain the specific type of performance study data requested.

Summary

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K020426

page 1 of 1

FEB 2 6 2002

Medtronic Sofamor Danek MSD WIRE System 510(k) Summary

Submitter:	Medtronic Sofamor Danek1800 Pyramid PlaceMemphis, TN 38132
Contact Person:	Richard Treharne
Trade Name:	MSD WIRE System
Classification Name:	Spinal Fixation Orthosis, Class II
Predicate Device(s):	The MSD WIRE System is substantially equivalent to itself, the ORFIL SpineFixation System, which was cleared in K934007 on June 06, 1994.
Device Description:	The MSD WIRE System construct consists of rods and segmental sublaminalwiring, being pre-formed and put in place by simple, commonly used,instrumentation. The purpose of this submission is to change the name of thesystem to the MSD WIRE System and to add previously cleared rods to theMSD WIRE System. The implant components are made of stainless steel asdescribed by ASTM Standard F138 or ISO 5832-1. Stainless steel and titaniumimplant components must not be used together in a construct.
Intended Use:	When properly used, this system will provide temporary stabilization until asolid spinal fusion develops. This system is intended for use only in thethoracic, lumbar and sacral levels of the spine. This system is not for use in thecervical spine. Specific indications include:
1.2.3.4.5.6.7.8.	Degenerative Disc Disease (DDD as defined as back pain of discogenic originwith degeneration of the disc confirmed by history and radiographic studies).Pseudoarthrosis.StenosisSpondylolisthesis.Spinal deformities such as scoliosis and lordosis.Fracture.Unsuccessful previous fusion surgery.Tumor resection.
Functionality &Safety Testing:	A Risk Analysis was performed on the MSD WIRE System and was includedin this submission.
Conclusion:	The subject components contained in this submission are substantiallyequivalent to the original ORFIL Spine Fixation System (K934007).

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three curved lines representing its wings.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 6 2002

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

K020426 Re:

Trade Name: MSD™ Wire System Regulation Number: 21 CFR 888.3050 Regulation Name: Spinal Interlaminal Fixation Orthosis Regulatory Class: II Product Code: KWP Dated: February 5, 2002 Received: February 8, 2002

Dear Dr. Treharne:

We have reviewed your Section 510(k) notification of intent to market the device referenced above we have reviewed your Section 310(k) nother or or alent (for the indications for use stated in and we have determined the device is substantially of the enatment date the enclosure) to devices marketed in intersale contact reclassified in accordance with the of the Medical Device Amendinenes, or to actives and Cosmetic Act (Act). You may, therefore, market the other warranisians of provisions of the Federal Food, Drug, and Cosmone Free (. The general controls provisions of the device, subject to the general controls provision, 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 If your device is classified (SCC above) into entrols. Existing major regulations affecting your Approval), it may be subject to sach additions, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice equirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requirelient, as set form in the Quant) by over couple (QS) inspections, the Food and Drug
and Drug regulation (FDA) will verify such assumptions. Failure to comply with the GMP regulation Administration (1 DA) will verty such assample the rannouncements concerning and concernatification may result in Tegulatory action. In addition, 1277 this response to your premarket notification your device in the Federal Register. Trease note: the response is 1 through 542 of the Act
submission does not affect any obligation you might have under sections 542 of the Submission docs not arrect any congation you might
for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Dr. Richard Treharne

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 nontication: "The PDF moung of sustian 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 (301) additionally 609110 101 m. 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 general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers on your responsionines and more (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

R. Mark N. Millikan

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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510(k) Number (if known): K020426

Device Name: MSD WIRE SYSTEM

Degenerative Disc Disease (DDD as defined as back pain of discogenic origin with degeneration l . of the disc confirmed by history and radiographic studies).
Pseudoarthrosis. 2.
Stenosis 3.
Spondylolisthesis. 4.
Spinal deformities such as scoliosis and lordosis. રું :
ર્ભ. Fracture.
Unsuccessful previous fusion surgery. 7.
Tumor resection. 8.

(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)

Over-the-counter Use __

Mark A. Millerson

Division of General. Restorative and Neurological Devic

510(k) Number K020926

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.