UNITY BETA PLLA SYSTEM

K090175 · Bonutti Research, Inc. · HWC · Sep 10, 2009 · Orthopedic

Device Facts

• Record ID: K090175
• Device Name: UNITY BETA PLLA SYSTEM
• Applicant: Bonutti Research, Inc.
• Product Code: HWC · Orthopedic
• Decision Date: Sep 10, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3040
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Unity Ultrasonic System consists of an electrical generator and ultrasonic handpiece. The system is to be used with existing Unity Alpha 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 handpiece; used with Unity Alpha absorbable (PLLA) implants for sutureless fixation of soft tissue, ligament, tendon, and bone. Generator provides ultrasonic energy to handpiece end effector to weld/join implant materials at repair site. Handpiece includes force sensor providing audible tone feedback to surgeon regarding applied load. Used in clinical settings by surgeons to facilitate suture management and secure repair sites. Benefits include sutureless fixation and real-time load feedback during procedure.

Clinical Evidence

Bench testing only. No clinical data presented. Evidence consists of design verification testing comparing electrical output of modified generator/handpiece to predicates and mechanical strength testing of Unity Alpha implants.

Technological Characteristics

System includes electrical generator and ultrasonic handpiece. Implants are absorbable poly-L-lactic acid (PLLA). Handpiece features integrated force sensor for load feedback. Energy source is electrical/ultrasonic. Connectivity/software details not specified.

Indications for Use

Indicated for general soft tissue approximation/ligation, including fixation of tissue, ligament, tendon, and bone using absorbable PLLA implants.

Regulatory Classification

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

• Unity Ultrasonic System (K090175)

Submission Summary (Full Text)

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0 50x 1357 lfingham, IL 62401 ודעס ספּאַזונגעסטע אַנאַמאַקענסאַ

# SEP 1 0 2009

# Bonutti Research, Inc. - Unity Ultrasonic System 1.090175 June 29, 2009

### 510(k) SUMMARY

The following information is submitted in accordance with the requirements of 21 CFR 807,92:

| Contact Person: | Patrick Balsmann, MBA, MS, RAC |
|-----------------|--------------------------------------------|
| | Director, Regulatory/Clinical Affairs & QA |
| | Bonutti Research, Inc., |
| | P.O. Box 1367 |
| | Effingham, Illinois 62401 |
| | Phone: [phone], ext. 321 |
| | Fax: [phone] |

Date Prepared: June 29, 2009

Proprietary Name: Unity Ultrasonic System

Common Name: Fixation Device

Classification Name: Fastener, Fixation, Biodegradable, Soft Tissue.

Device Description: The Unity Ultrasonic System is designed for the fixation of soft tissue, ligament, tendon, and bone. Absorbable poly-L-laotic acid (PLLA) implant materials are ultrasonically welded, staked, and/or joined to secure soft tissue, ligament, teadon, and bone at a repair site. An olectrical generator provides ultrasonic energy to the end effector of a handpiece to fix the implant materials together and secure soft tissue, ligament, rendon, and/or bone. The system provides a means of sutureless fixation that facilitates overall suture management. Modifications are being made to the electrical generator and ultrasonic handpiece components of the ultrasonic system to improve overall system performance and to enhance user interface features. Additionally, the handpiece is being modified to 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.

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K090175\$\frac{2}{2}\$

Bonutti Research, Inc. - Unity Ultrasonic System 510(k) Summary - June 29, 2009 Page 2

Indications for Use: The Unity Ultrasonic System consists of an electrical generator and ultrasonic handpiece. The system is to be used with existing Unity Alpha 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.

Predicate Device(s): The Unity Ultrasonic System is similar in design and intended use I redicate Device(s). The Dury - electrical generators and ultrasonic handpieces used in sutureless fixation and previously determined substantially equivalent.

Predicate Comparison: Design verification testing identified and conducted as part of I i culture Comparison: compared the electrical output of the modified Unity Ultrasonic System electrical generator and ultrasonic handpiece to similar component predicate devices. Mechanical strength testing was also conducted with Unity Alpha predicate devices: for both the modified Unity Ultrasonic System and its predicate ultrasonic systems.

Submitted by:

Cathy Baker

Patrick Balsmann, MBA, MS, RAC Director, Regulatory/Clinical Affairs & QA

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# 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 consists of a stylized eagle or bird symbol, with three curved lines forming the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

# SEP 1 0 2009

Bonutti Research, Inc. % Mr. Patrick G. Balsmann 2600 South Raney Street P.O. Box 1367 Effingham, IL 62401

SEP. 1 2009

Re: K090175 Trade/Device Name: Unity Ultrasonic System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC. MAI

Dated: August 27, 2009

Received: August 28, 2009

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.

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 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.

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Page 2 - Mr. Patrick G. Balsmann

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/cdrh/comp/ 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/cdriv/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 toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Barbara Buchus

Mark N. Melk Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

### 510(k) Number: K090175

Device Name: Unity Alpha System

Indications For Use: The Unity Ultrasonic System consists of an electrical generator and ultrasonic handpiece. The system is to be used with existing Unity Alpha 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.

X Prescription Use ... 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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Vivision Sign Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K090175