TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH IBLOCK

K090953 · Praxim Medivision, SA · OLO · Jan 21, 2010 · Neurology

Device Facts

Record IDK090953
Device NameTOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH IBLOCK
ApplicantPraxim Medivision, SA
Product CodeOLO · Neurology
Decision DateJan 21, 2010
DecisionSESE
Submission TypeSpecial
Regulation21 CFR 882.4560
Device ClassClass 2

Intended Use

The TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH IBLOCK is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures. It is specifically indicated for: - Total Knee Arthroplasty

Device Story

Image-guided surgical navigation system for Total Knee Arthroplasty; aids surgeon in locating anatomical structures and aligning endoprostheses. System components: mobile computer station (Surgetics or NanoStation), optical localizer, ancillary instruments, reflective markers, and motorized cutting block (iBlock). Surgeon uses system to register anatomy; system guides positioning of motorized cutting block; surgeon performs bone cuts using traditional saw. Used in OR by surgeons. Provides real-time guidance to improve surgical accuracy and alignment of implants.

Clinical Evidence

Bench testing and specimen testing only. No clinical data provided. Testing demonstrated that system accuracy and performance are adequate for intended use and equivalent to the predicate device.

Technological Characteristics

Stereotaxic surgical navigation system. Components: mobile computer station, optical localizer, reflective markers, motorized cutting block (iBlock). Operates via optical tracking of anatomical structures and instruments. Software-controlled guidance for implant alignment. Class II device (Product Code: OLO).

Indications for Use

Indicated for patients undergoing Total Knee Arthroplasty.

Regulatory Classification

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

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Page 1 of (3) ## 510(k) Summary K090953 ## for ## TOTAL KNEE SURGETICS Navigation System with iBlock #### Submitter Name and Address: 1. Praxim "Le Grand Sablon" 4, Avenue de l'Obiou 38 700 La Tronche France 心 JAN 2 1 2010 Contact Name: Sebastien Burtin Telephone: (+33) 4 76.54 95 03 Date Prepared: March 13th 2009 #### 2. Device Name: TOTAL KNEE SURGETICS Navigation System with Proprietary Name: iBlock Common/Usual Name: Image guided surgical navigation system Classification Name: Stereotaxic instrument #### 3. Predicate Device: PRAXIM - TOTAL KNEE SURGETICS Navigation System with Praxiteles (K081232) ్లు {1}------------------------------------------------ K090953 #### 4. Intended Use: Page 2 of 3 The TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH IBLOCK is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures. It is specifically indicated for: - Total Knee Arthroplasty o #### 5. Device Description: As the equivalent TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH PRAXITELES, the TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH IBLOCK consists of the following major components and subsystems: - The Station (Surgetics or NanoStation), consisting of a mobile computer ● system and an optical localizer - . Ancillary instruments, a specific motorized cutting block and reflective markers used for reference and registration - TOTAL KNEE SURGETICS software application with iBlock option . The main modification to the predicate device K081232 concerns the modification of the motorized cutting block PRAXITELES®. #### Technological Characteristics and Substantial Equivalence 6. The underlying technology of the TOTAL KNEE SURGETICS Navigation System with iBlock is the same as for the predicate device K081232. The system is based on the same operating principle and control mechanism to provide the user with the same kind of information and guidance for the same surgery. The main changes with respect to the predicate device concern the modification of the motorized cutting block Praxiteles. The iBlock® is an improved version of the Praxiteles motorized cutting block and is also controlled by the navigation system. Once the cutting block has been positioned to the desired cut, the surgeon can proceed to the cut as it is done in the conventional way using a traditional saw. {2}------------------------------------------------ K 0 90 953 # ್ಗಳ #### 7. Performance Testing The TOTAL KNEE SURGETICS Navigation System with iBlock was tested in a non clinical setting (bench testing, specimen) to assess that no new safety and efficiency issues were raised with this device. Analyses show that the accuracy and performance of the system are adequate for its intended use and not reduced in comparison to the predicate device. In conclusion the modified device TOTAL KNEE SURGETICS Navigation System with iBlock is substantially equivalent to the predicate device. {3}------------------------------------------------ Image /page/3/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle. ### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0605 Silver Spring, MD 20993-0002 Praxim S.A. % Mr. Sébastien Burtin Regulatory Affairs and Quality Assurance Director Le Grand Sablon 4, Avenue De L'Obiou 38700 La Tronche, France JAN 2 1 2010 Re: K090953 Trade/Device Name: TOTAL KNEE SURGETICS Navigation System with iBlock Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO Dated: December 16, 2009 Received: December 23, 2009 Dear Mr. Burtin: 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 the Pederal Food, Drug, You may therefore, market the donice 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 misting and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 {4}------------------------------------------------ Page 2 - Mr. Sébastien Burtin comply with all the Act's requirements, including, but not limited to: registration and ligting (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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 100-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm11.5809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (2) CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tolling the (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Mark V. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "BRAHIM" in a stylized, blocky font. Each letter is formed with thick lines, giving it a bold and somewhat industrial appearance. The letters are evenly spaced and aligned horizontally, creating a clear and legible word. PRAXIM S.A. LE GRAND SABLON 4, AVENUE DE L'OBIQU 38700 Fr TRONCHE France PHONE +33 4 76 54 95.03 になる +33 × 76 × 1.93 20 હે. ને. ਕਪ CAPITAL DE 3.448.888.800 NO SIRET 400 491 304 00020 CODE APE 331 B ww.praxim.com Praxim 510(k) ## STATEMENT OF INDICATIONS FOR USE ## TOTAL KNEE SURGETICS Navigation System with iBlock 510(k) Number (if known): KO90953 Device Name: TOTAL KNEE SURGETICS Navigation System with iBlock The TOTAL KNEE SURGETICS Navigation System with iBlock is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures. It is specifically indicated for : * Total Knee Arthroplasty Prescription Use X AND / OR (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Praxim 510(k) March 13ʰ 2009 Concurrence of CDRH, Office of Device Evaluation (ODE) TOTA KNEE SURGETICS Navigation System with Division Sign-Off) CONFIDENTIAL Page 1/1 Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K090952
Innolitics
510(k) Summary
Decision Summary
Classification Order
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