← Product Code [HAW](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAW) · K020298 # GALILEO CAS/NAV TKR SYSTEM (K020298) _Plus Orthopedics · HAW · May 20, 2002 · Neurology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAW/K020298 ## Device Facts - **Applicant:** Plus Orthopedics - **Product Code:** [HAW](/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAW.md) - **Decision Date:** May 20, 2002 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 882.4560 - **Device Class:** Class 2 - **Review Panel:** Neurology ## Indications for Use The GALILEO CAS/NAV TKR System is intended for computer-assisted navigation of the GALILEO-CAS instruments with the aim to position the implants of the TC-PLUS™ Solution Knee (K000666 - S/E 10/13/00) optimally for the patient. ## Device Story System provides computer-assisted navigation for total knee replacement (TKR) surgery; used intraoperatively by surgeons. Inputs include anatomical bone landmarks captured via manual navigation key button and spatial tracking of instruments via infrared camera. System utilizes two active infrared transmitters attached to distal femur and proximal tibia, plus two passive locators for instrument arrangement. Computer processes spatial data to control small electric motors on femur-cutting device, ensuring precise positioning for bone resections. No preoperative CT scan required. Output provides real-time guidance for cutting device alignment; enables accurate, flexible resection. Benefits include improved implant positioning accuracy for TC-PLUS Solution Knee prostheses. ## Clinical Evidence Bench testing only. Biomechanical tests performed; results equivalent to similar implants and sufficient for in vivo loading. ## Technological Characteristics System consists of electronic components and instruments. Uses infrared camera for tracking active/passive locators. Instruments feature low-voltage electric motors for positioning. Operates via intraoperative landmark scanning without preoperative CT. Class II device (Stereotaxic instrument). ## 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 - OrthoPilot ([K003347](/device/K003347.md)) ## Reference Devices - TC-PLUS Solution Knee ([K000666](/device/K000666.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}------------------------------------------------ MAY 2 0 2002 Kozo298 510/k) Summary of Safety and Effectiveness [in accordance with SMDA of 1990, 21 CFR 807.92(c)] Contact: PLUS ORTHOPEDICS 6055 Lusk Blvd. San Diego, CA 92121 Tel: 858-550-3800 x 2506 - Fax: 858-550-3813 Attn: Mr. Hartmut Loch, RAC Director, Regulatory Affairs Trade name: GALILEO CAS/NAV TKR System Common name: Navigation System Classification name: Instrument, Stereotaxic & 882.4560, Class II, Neurologic Device Panel 82 Product Code: HAW Description The GALILEO CAS/NAV TKR System is a system for computer-Device and Characteristics: assisted navigation of the GALILEO-CAS instruments with the aim to position TC-PLUS™ Solution Knee prostheses optimally for the patient. The collection of patient data required for this occurs exclusively operatively. A preoperative CT scan is not necessary. The connection between patient and computer is made via two infrared transmitters (active locators), which are attached to the distal femur and to the Two passive locators are used for the spatial proximal tibia. arrangement of the instruments. A manual navigation key button is used for scanning the anatomical bone features (landmarks). An infrared camera locates the locators as well as the manual key button and is connected to the computer. The computer-assisted Galileo CAS Total Knee Replacement System supports the operating surgeon performing the total knee replacement procedure. The system takes the femur-cutting device to the required position and enables resections with high accuracy and flexibility. > Due to the precise computer-assisted references and the correct positioning of the cutting device the bone resections can be performed with the utmost accuracy. > The Galileo CAS system essentially consists of two components, the electronic components and the instruments, which are attached to the distal femur. The instruments, which are driven by small electric (lowvoltage) motors, are controlled by the computer, to ensure correct positioning of the femur-cutting device. {1}------------------------------------------------ The GALILEO CAS/NAV TKR System is substantially equivalent to the Equivalence: OrthoPilot® (Aesculap, Inc. – K003347 – S/E 2/23/2001). Both systems are intended for the same medical indications and are technically similar. The GALILEO CAS/NAV TKR System is intended for computer-Indications: assisted navigation of the GALILEO-CAS instruments with the aim to position the implants of the TC-PLUS™ Solution Knee (K000666 - S/E 10/13/00) optimally for the patient. - Biomechanical tests have been performed. The test results were Performance data: equivalent to other similar implants and are sufficient for in vivo loading. {2}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing right, stacked on top of each other, with flowing lines beneath them. #### Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY 2 0 2002 Mr. Hartmut Loch, RAC Director, Regulatory Affairs Plus Orthopedics 6055 Lusk Boulevard San Diego, CA 92121-2700 Re: K020298 Trade/Device Name: GALILEO CAS/NAV TKR System Regulation Number: 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: II Product Code: HAW Dated: April 12, 2002 Received: April 15, 2002 Dear Mr. Loch: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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. {3}------------------------------------------------ ## Page 2 - Mr. Hartmut Loch, RAC 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, Muriam C. Provost Celia Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ #### Kodod 510(k) Number: Device Name(s): # GALILEO CAS/NAV TKR SYSTEM ### Indications for Use: The GALILEO CAS/NAV TKR System is intended for computer-assisted The GALILES Of the GALILEO-CAS instruments with the aim to position the navigation of the ORE/EB ONE "","Solution Knee (K000666 - S/E 10/13/00) optimally for the patient. PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE) Miriam C. Provost (Division Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number K020298 Prescription Use OR Over-The-Counter-Use _________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109) (Optional format 1-2-96) --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAW/K020298](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94neurological-surgical-devices/HAW/K020298) **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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