← Product Code [HWC](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC) · K093078 # UNITY ULTRASONIC SYSTEM WITH PLLA ANCHORS (K093078) _Bonutti Research, Inc. · HWC · Jun 23, 2010 · Orthopedic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K093078 ## Device Facts - **Applicant:** Bonutti Research, Inc. - **Product Code:** [HWC](/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC.md) - **Decision Date:** Jun 23, 2010 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 888.3040 - **Device Class:** Class 2 - **Review Panel:** Orthopedic - **Attributes:** Therapeutic ## Intended Use The Unity Ultrasonic System consists of an electrical generator and ultrasonic handpieces. The system is to be used with Unity single patient use absorbable (PLLA) implants intended for use as fasteners (anchors) in the fixation of tissue, ligament, tendon, and bone. The system is indicated in general soft tissue approximation/ligation. ## Device Story System comprises electrical generator and ultrasonic handpieces; used with single-patient-use absorbable PLLA implants. Surgeon operates handpiece to ultrasonically weld, stake, or join implant portions at repair site; secures soft tissue, ligament, tendon, and bone. Handpiece includes force sensor mechanism providing audible tone feedback to surgeon regarding applied load. Used in clinical settings for surgical fixation. Output is physical fixation of tissue via welded PLLA material; provides surgeon with tactile and auditory feedback during procedure to ensure appropriate load application. ## Clinical Evidence Bench testing only. Comparison of mechanical strengths and failure modes of implants welded by 40 kHz and 20 kHz handpieces showed statistically equivalent strengths. Electrical safety and EMC testing performed. Risk evaluation confirmed no new safety or effectiveness concerns. ## Technological Characteristics System includes electrical generator and ultrasonic handpieces (20 kHz and 40 kHz). Implants are absorbable poly-L-lactic acid (PLLA). Handpieces feature integrated force sensor mechanism with audible tone feedback. Sterilization techniques are consistent with predicate devices. ## Regulatory Identification A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system. ## Predicate Devices - Bonutti Research, Inc. ultrasonic systems (electrical generators and ultrasonic handpieces) and Unity Implants ([K093078](/device/K093078.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}------------------------------------------------ Image /page/0/Picture/0 description: The image displays the logo for "BONUTTI TECHNOLOGIES." The word "BONUTTI" is in large, bold, black letters on the top line. Below it, in smaller, but still bold, black letters, is the word "TECHNOLOGIES." The logo is simple and professional. O Box 1367 ffingham, IL 62401 Phone: 217.342.3412 217.342.3460 http://www.bonuttitec.com ## K093078 Bonutti Research, Inc. Unity Ultrasonic System with PLLA Fasteners June 3, 2010 **JUN 23 2010** ## 510(k) SUMMARY The following information is submitted in accordance with the requirements of 21 CFR 807.92: | Contact Person: | Patrick Bálsmann, MBA, MS, RAC | |-----------------|--------------------------------------------| | | Director, Regulatory/Clinical Affairs & QA | | | Bonutti Research, Inc., | | | P.O. Box 1367 | | | Effingham, Illinois 62401 | | | Phone: (217) 342-3412, ext. 321 | | | Fax: (217) 342-1043 | Date Prepared: June 3, 2010 Proprietary Name: Unity Ultrasonic System with PLLA Fasteners Common Name: Fixation Device Classification Name: Fastener, Fixation, Biodegradable, Soft Tissue. Device Description: The Unity Ultrasonic System with PLLA Fasteners is designed for the fixation of soft tissue, ligament, tendon, and bone. Absorbable poly-L-lactic acid (PLA) implant materials are ultrasonically welded, staked, and/or joined to secure soft tissue, ligament, tendon, and bone at a repair site. An electrical generator provides ultrasonic energy to the end effector of a handpiece to fix the implant materials together and secure soft tissue, ligament, tendon, and/or bone. Energy applied to the trailing end of the implant portion contacting the handpiece end effector joins this implant portion to the other implant portion in securing soft tissue, ligament, tendon, and bone. Ultrasonic handpieces with end effectors designed to accommodate Unity Implants are product specific and include a force sensor mechanism that allows the surgeon feedback on the amount of load they are applying to the handpiece. Feedback is provided to the surgeon through an audible tone. Indications for Use: The Unity Ultrasonic System with PLLA Fasteners consists of an electrical generator and ultrasonic handpieces. The system is to be used with Unity single patient use absorbable (PLLA) implants intended for use as fasteners (anchors) in the fixation of tissue, ligament, tendon, and bone. The system is indicated in general soft tissue approximation/ligation. Page 1 of 2 {1}------------------------------------------------ K093078 Bonutti Research, Inc. Unity Ultrasonic System with PLLA Fasteners 510(k) Summary - June 3, 2010 Page 2 of 2 Predicate Device(s): The Unity Ultrasonic System with PLLA Fasteners is similar in design and intended use to existing Bonutti Research, Inc., ultrasonic systems (electrical generators and ultrasonic handpieces) and Unity Implants used in sutureless fixation and previously determined substantially equivalent. Predicate Comparison: The modification to the Unity Ultrasonic System with PLLA Fasteners to its predicate ultrasonic systems includes the addition of a 40 kHz handpiece to the existing 20 kHz handpiece. Both handpieces are used with the same electrical generator to ultrasonically weld, stake, and/or join absorbable poly-L-lactic acid (PLLA) implant portions together to secure soft tissue, ligament, tendon, and bone at a repair site. The 40 kHz handpiece is similar in design, packaging, and labeling to its opedicate handpiece. Each handpiece has similar cleaning and sterilization techniques. Predicate Verification: Design verification testing with identified acceptance criteria conducted to determine substantial equivalence among the predicate devices noted in the preceding section included; (1) A comparison of the mechanical strengths and failure modes among the two handpieces and their respective implants when ultrasonically welded. Implant strengths were statistically equivalent among the respective implants tested. (2) An electrical safety and EMC test plan with related acceptance criteria was defined. (3) A risk evaluation of the 40 kHz handpiece to its predicate demonstrated similar design, packaging, labeling, and sterilization techniques that raise no concerns regarding the safe and effective use of the Unity Ultrasonic System with PLLA Fasteners. Submitted by: Vito R. Palmieri Patrick Balsmann, MBA, MS, RAC Director, Regulatory/Clinical Affairs & QA {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The bird is facing to the right. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 ## JUN 2 3 2010 Bonutti Research, Inc % Mr. Patrick Balsmann, MBA, MS, RAC Director, Regulatory/Clinical Affairs & QA P.O. Box 1367 Effingham, Illinois Re: K093078 Trade/Device Name: Unity Ultrasonic System with PLLA Fasteners Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, MAI Dated: June 3, 2010 Received: June 4, 2010 Dear Mr. Balsmann: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 {3}------------------------------------------------ Page 2 - Mr. Patrick Balsmann, MBA, MS, RAC 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 1000-1050. 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/ucm115809.htm 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 (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm 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 toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely vours. Sincerely yours, Mark A. Millburn Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## Indications for Use 510(k) Number: K093078 Device Name: Unity Ultrasonic System with PLLA Fasteners Indications For Use: The Unity Ultrasonic System consists of an electrical generator and ultrasonic handpieces. The system is to be used with Unity single patient use absorbable (PLLA) implants intended for use as fasteners (anchors) in the fixation of tissue, ligament, tendon, and bone. The system is indicated in general soft tissue approximation/ligation. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1 - Sonetu for mcm (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K093078 --- **Source:** [https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K093078](https://fda.innolitics.com/submissions/OR/subpart-d%E2%80%94prosthetic-devices/HWC/K093078) **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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