← Product Code [JDX](/submissions/OR/subpart-e%E2%80%94surgical-devices/JDX) · K031280 # ULTRA-DRIVE 3 (K031280) _Biomet, Inc. · JDX · Sep 22, 2003 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94surgical-devices/JDX/K031280 ## Device Facts - **Applicant:** Biomet, Inc. - **Product Code:** [JDX](/submissions/OR/subpart-e%E2%80%94surgical-devices/JDX.md) - **Decision Date:** Sep 22, 2003 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 888.4580 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use Cutting and removal of bone and acrylic bone cement in orthopedic applications ## Device Story Ultra-Drive 3 is an ultrasonic surgical instrument system comprising a control console, footswitch, handpiece, cables, and tool tips. The system converts 120/240V electrical power into 40 kHz electrical energy, which is transmitted to a transducer. The transducer converts this energy into longitudinal 40 kHz ultrasonic vibrations, delivered to the tool tip for bone or bone cement removal. Used in orthopedic surgical settings by clinicians. The device facilitates precise tissue and cement removal through ultrasonic vibration. ## Clinical Evidence No clinical data provided. ## Technological Characteristics Ultrasonic surgical instrument; 40 kHz operating frequency; converts electrical energy to longitudinal mechanical vibrations; includes control console, footswitch, handpiece, and tool tips; powered by 120/240V electrical source. ## Regulatory Identification A sonic surgical instrument is a hand-held device with various accessories or attachments, such as a cutting tip that vibrates at high frequencies, and is intended for medical purposes to cut bone or other materials, such as acrylic. ## Special Controls *Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 888.9. ## Predicate Devices - System 10, Model 100 Surgical System for Orthopedic Use ([K900003](/device/K900003.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}------------------------------------------------ SEP 2 2 2003 K 031280 Vh BIOMET ## Summary of Safety and Effectiveness Applicant/Sponsor:Biomet Orthopedics, Inc. Patricia Sandborn Beres Contact Person: Senior Requlatory Specialist Proprietary Name: Ultra-Drive® 3 Common or Usual Name: Ultrasonic Surgical Instrument Classification Name: Instrument, Surqical, Sonic and Accessories/Attachments (21 C.F.R. 888.4580) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: The Ultra-Drive® 3 system is substantially equivalent to the System 10, Model 100 Surgical System for Orthopedic Use, cleared through 510(k) K900003. Device Description: The Ultra-Drive® 3 consists of a control console, a footswitch, a handpiece with associated cables and connecting tubing, a variety of tool tips and other associated accessories. The system converts standard electrical power (120/240V) into electrical energy at 40 kHz. The high frequency electrical energy produced by the generator is sent through a cable to a transducer that changes the electrical energy into longitudinal 40kHz vibrations. The ultrasonic vibrations are then transmitted to the tool tip that is supplied to the bone or bone cement which is to be removed. Intended Use: Cutting and removal of bone and acrylic bone cement in orthopedic applications Summary of Technologies: The materials and operating principles of the Ultra-Drive® 3 system are similar to that of the predicate. Clinical and Non-Clinical Testing: None provided All trademarks are property of Biomet, Inc. MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581 0587 SHIPPING ADDRESS 56 E. Bell Drive 56 E. Bell Drive Warsaw, IN 46582 I ( ) FFICE 57-1.267.6639 FAX 574.267.8137 E-MAIL biomet@bionnet.com {1}------------------------------------------------ Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter of the circle. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight. The symbol is composed of three curved lines that form the body and wings of the bird, and two wavy lines that form the tail feathers. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 SEP 2 2 2003 Ms. Patricia Sandborn Beres Senior Regulatory Specialist Biomet, Inc. 56 East Bell Drive P.O. Box 587 Warsaw, Indiana 46581-0587 Re: K031280 Trade/Device Name: Ultra-Drive 3 Regulation Number: 21 CFR 888.4580 Regulation Name: Sonic Surgical Instrument and Accessories/Attachments Regulatory Class: II Product Code: JXJ Dated: July 8, 2003 Received: July 9, 2003 Dear: Ms. Beres: 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. {2}------------------------------------------------ ## Page 2 - Ms. Patricia Sandborn Beres 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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, Miriam C. Provost for 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): X (13) 280 Device Name: Ultra-Drive® 3 ## Indications For Use: Cutting and removal of bone and acrylic bone cement in orthopedic applications. Miriam C. Provost (Division Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number K031280 (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%94surgical-devices/JDX/K031280](https://fda.innolitics.com/submissions/NE/subpart-e%E2%80%94surgical-devices/JDX/K031280) **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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