← Product Code [HAW](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAW) · K012937 # KNEE MODULE FOR THE STEALTHSTATION SYSTEM (K012937) _Medtronic Surgical Navigation Technologies · HAW · Jan 25, 2002 · Neurology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAW/K012937 ## Device Facts - **Applicant:** Medtronic Surgical Navigation Technologies - **Product Code:** [HAW](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAW.md) - **Decision Date:** Jan 25, 2002 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 882.4560 - **Device Class:** Class 2 - **Review Panel:** Neurology ## Intended Use The StealthStation® System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation® System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT or MR based model or fluoroscopy images of the anatomy. Example procedures include, but are not limited to: Cranial Procedures: Cranial biopsies Tumor resections Craniotomies/ Craniectomies Skull base procedures Thalamotomies/Pallidotomies Pituitary Tumor Removal CSF Leak Repair ENT Procedures: Transphenoidal procedures Intranasal procedures Orbital Decompression Procedures Optic Nerve Decompression Procedures Polyposis Procedures Endoscopic Dacryocystorhinostomy Encephalocele Procedures Sinus procedures, such as Maxillary antrostomies, Ethmoidectomies, Sphenoidotomies/Sphenoid explorations, Turbinate resections, and Frontal sinusotomies Orthopedic Procedures: Total Knee Arthroplasty (Primary and Revision) Unicompartmental Knee Arthroplasty Spinal Procedures: Spinal implant procedures, such as pedicle screw placement. ## Device Story StealthStation® System Knee Module provides image-guided navigation for orthopedic surgery; specifically total and unicompartmental knee arthroplasty. System utilizes CT, MR, or fluoroscopic images as input to create anatomical models. Device tracks rigid anatomical structures relative to these images to assist surgeons in precise instrument/implant positioning. Used in OR by surgeons; provides real-time visual feedback on display. Enhances surgical accuracy; potentially improves patient outcomes in joint replacement procedures. ## Clinical Evidence No clinical data provided. Substantial equivalence supported by performance data. ## Technological Characteristics Stereotaxic instrument (Regulation 882.4560). System integrates with existing StealthStation® hardware for image-guided navigation. Utilizes CT, MR, or fluoroscopic imaging data. Connectivity via standard StealthStation® architecture. Sterilization requirements follow established system protocols. ## Regulatory Identification A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system. ## Predicate Devices - StealthStation® System - FluoroNav™ Module for the StealthStation® System - Orthopilot® System ## Related Devices - [K043088](/device/K043088.md) — MEDTRONIC SNT STEALTHSTATION AXIEM IMAGELESS KNEE MODULE · Medtronic Surgical Navigation Technologies · Jan 5, 2005 - [K033011](/device/K033011.md) — ZIMMER ORTHO GUIDANCE SYSTEMS- KNEE INSTRUMENTS · Zimmer, Inc. · Feb 12, 2004 - [K030552](/device/K030552.md) — IMAGELESS KNEE MODULE FOR THE STEALTHSTATION SYSTEM · Medtronic Surgical Navigation Technologies · Mar 19, 2003 - [K060336](/device/K060336.md) — NAVITRACK SYSTEM-OS KNEE UNIVERSAL, MODEL PRO-05002 · Orthosoft, Inc. · Apr 28, 2006 - [K022579](/device/K022579.md) — STRYKER NAVIGATION SYSTEM-KNEE MODULE · Stryker Leibinger · Jun 2, 2003 ## Submission Summary (Full Text) {0}------------------------------------------------ JAN 2 5 2002 # Summary of Safety and Effectiveness ### Knee Module for the StealthStation® System - Medtronic Surgical Navigation Technologies I. Company: 826 Coal Creek Circle Louisville, CO 80027 (720) 890-3200 - Product Name: Knee Module for the StealthStation® System II. - This submission describes a modification to the StealthStation® System FluoroNav™ III. Module to provide for image guided knee surgery and orthopedic indications. - The indications for use for the Knee Module for the StealthStation® System are as IV. follows: The StealthStation® System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The StealthStation® System is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT or MR based model or fluoroscopy images of the anatomy. Example procedures include, but are not limited to: Cranial Procedures: Cranial biopsies Tumor resections Craniotomies/ Craniectomies Skull base procedures Thalamotomies/Pallidotomies Pituitary Tumor Removal CSF Leak Repair ENT Procedures: Transphenoidal procedures Intranasal procedures Orbital Decompression Procedures Optic Nerve Decompression Procedures Polyposis Procedures Endoscopic Dacryocystorhinostomy Encephalocele Procedures Sinus procedures, such as Maxillary antrostomies, Ethmoidectomies, Sphenoidotomies/Sphenoid explorations, Turbinate resections, and Frontal sinusotomies Orthopedic Procedures: pedicle screw placement. Spinal Procedures: Total Knee Arthroplasty (Primary and Revision) Unicompartmental Knee Arthroplasty Spinal implant procedures, such as - The Knee Module for the StealthStation® System was shown to be substantially equivalent V. 1110 Knoor inoade 101 Ris Brown. System, the FluoroNav™ Module for the StealthStation® System and the Orthopilot® System. Performance data was provided to support the claim of substantial equivalence. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image is a black and white circular seal for the Department of Health & Human Services - USA. The seal features the department's name in a circular pattern around the edge. In the center of the seal is an abstract image of a bird or eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## JAN 2 5 2002 Victoria G. Rendon Clinical and Regulatory Affairs Associate Medtronic Surgical Navigation Technologies 826 Coal Creek Circle Louisville, Colorado 80027 Re: K012937 Trade Name: Knee Module for the Stealthstation® System Regulation Number: 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: November 26, 2001 Received: November 27, 2001 Dear Ms. Rendon: We have reviewed your Section 510(k) premarket 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {2}------------------------------------------------ ### Page 2 - Ms. Victoria Rendon This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, bo Mich n Millerson 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): Device Name: Knee Module for the StealthStation® System #### Indications For Use: The StealthStation® System is intended as an aid for precisely locating anatomical structures in I he Steallinstation® System is an are for processor System is indicated for any medical entified of perculaneous proceants. The creating be appropriate, and where reference to a condition in wincil the use of stereoucate only of your sprestebra, can be identified relative to a CT or MR based model or fluoroscopy images of the anatomy. Example procedures include, but are not limited to: Cranial Procedures: Cranial biopsies Tumor resections Craniotomies/ Craniectomies Skull base procedures Thalamotomies/Pallidotomies Pituitary Tumor Removal CSF Leak Repair ENT Procedures: Transphenoidal procedures Intranasal procedures Orbital Decompression Procedures Optic Nerve Decompression Procedures Polyposis Procedures Endoscopic Dacryocystorhinostomy Encephalocele Procedures Sinus procedures, such as Maxillary antrostomies, Ethmoidectomies, Sphenoidotomies/Sphenoid explorations, Turbinate resections, and Frontal sinusotomies Spinal Procedures: Spinal implant procedures, such as pedicle screw placement. Orthopedic Procedures: Total Knee Arthroplasty (Primary and Revision) Unicompartmental Knee Arthroplasty Mark McNemar Restorative and Neurologic 510(k) Number (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office Of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1-2-96) --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAW/K012937](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAW/K012937) **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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