← Product Code [KWP](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWP) · K020426 # MSD WIRE SYSTEM (K020426) _Medtronic Sofamor Danek, Inc. · KWP · Feb 26, 2002 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWP/K020426 ## Device Facts - **Applicant:** Medtronic Sofamor Danek, Inc. - **Product Code:** [KWP](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWP.md) - **Decision Date:** Feb 26, 2002 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 888.3050 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use 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: 1. Degenerative Disc Disease (DDD as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies). 2. Pseudoarthrosis. 3. Stenosis 4. Spondylolisthesis. 5. Spinal deformities such as scoliosis and lordosis. 6. Fracture. 7. Unsuccessful previous fusion surgery. 8. Tumor resection. ## Device Story MSD WIRE System consists of rods and segmental sublaminal wiring; provides temporary spinal stabilization until solid fusion occurs. Used in thoracic, lumbar, and sacral spine. Implanted by surgeons using standard instrumentation. Components made of stainless steel. System facilitates structural support for spinal pathologies; prevents movement during healing process. Benefits patient by maintaining alignment and stability post-operatively. ## Clinical Evidence No clinical data. Bench testing and risk analysis performed. ## Technological Characteristics Stainless steel (ASTM F138 or ISO 5832-1). Rod and sublaminal wire construct. Manual instrumentation. Not compatible with titanium components. ## Regulatory 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. ## Predicate Devices - ORFIL Spine Fixation System ([K934007](/device/K934007.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K020426 page 1 of 1 FEB 2 6 2002 # Medtronic Sofamor Danek MSD WIRE System 510(k) Summary | Submitter: | Medtronic Sofamor Danek
1800 Pyramid Place
Memphis, 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 Spine
Fixation System, which was cleared in K934007 on June 06, 1994. | | 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. | | Intended Use: | 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: | | 1.
2.
3.
4.
5.
6.
7.
8. | 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. | | Functionality &
Safety Testing: | A Risk Analysis was performed on the MSD WIRE System and was included
in this submission. | | Conclusion: | The subject components contained in this submission are substantially
equivalent to the original ORFIL Spine Fixation System (K934007). | {1}------------------------------------------------ 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. {2}------------------------------------------------ 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 {3}------------------------------------------------ ### 510(k) Number (if known): K020426 ### Device Name: MSD WIRE SYSTEM 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 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) OR Over-the-counter Use __ Mark A. Millerson Division of General. Restorative and Neurological Devic 510(k) Number K020926 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWP/K020426](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/KWP/K020426) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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