ELIBRA DYNAMIC KNEE BALANCER

K070108 · Synvasive Technology, Inc. · ONN · Apr 4, 2007 · Neurology

Device Facts

• Record ID: K070108
• Device Name: ELIBRA DYNAMIC KNEE BALANCER
• Applicant: Synvasive Technology, Inc.
• Product Code: ONN · Neurology
• Decision Date: Apr 4, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

For use as a tool for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry. The force sensor is sterile, for single patient use.

Device Story

eLibra Dynamic Knee Balancer consists of a single-use, battery-powered force-sensing tibial unit and a reusable, battery-powered electronic display unit. Used during total knee arthroplasty (TKA) by surgeons to balance soft tissue structures. The tibial unit measures medial and lateral compartment forces generated by soft tissue surrounding the knee joint and transmits this data wirelessly to the display unit. The display unit provides a numerical output (0-19) for both compartments, aiding the surgeon in adjusting the femoral implant to correct flexion gap asymmetry. This real-time feedback assists in achieving joint stability, potentially improving patient outcomes post-TKA.

Clinical Evidence

Clinical testing was performed to evaluate the adequacy of instructions for use, patient population range, performance characteristics, and reliability. Results were satisfactory, demonstrating safety and effectiveness equivalent to the predicate device.

Technological Characteristics

System comprises a single-use force-sensing tibial unit and a reusable electronic display unit. Features wireless connectivity for signal transmission. Powered by batteries. Sterilization of the force sensor is required. Operates as an orthopedic manual surgical instrument with electronic enhancement.

Indications for Use

Indicated for use as a tool for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry during total knee arthroplasty (TKA).

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

• Libra Dynamic Knee Balancer (510(k) exempt)

Submission Summary (Full Text)

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## APR 4 - 2007

K 070108

510(K) Summary Synvasive Technology, Inc. 4925 Robert J. Mathews Pkwy El Dorado Hills, CA 95762 Phone: [phone] Contact: Michael G. Fisher Date prepared: December 20, 2006

- Trade Name: eLibra Dynamic Knee Balancer 1. Common Name: Orthopedic manual surgical instrument Classification Name: Orthopedic manual surgical instrument, product code LXH, Regulation: 888.4540 Class of device: Class I.
- The legally marketed device to which we are claiming equivalence [807.92(a)(3)] : The 2. Libra Dynamic Knee Balancer (510(k) exempt) manual orthopedic surgical instrument set.
- Description of device: The device consists of two units, the force sensing unit and an 3. electronic display. The eLIBRATM Force Sensing Tibial Unit is a single use battery powered device designed to transmit an electronic signal to the eLIBRA™ Display Unit. The electronic signal represents the relative medial and lateral compartment forces generated from the soft tissue structures surrounding the knee joint during a total knee arthroplasty (TKA). The LIBRA Dynamic Knee Balancer eLIBRATM Display Unit is a reusable battery powered device designed to receive an electronic signal from the eLIBRATM Force Sensing Tibial Unit. The unit displays a number from 0-19 for both the medial and lateral compartments in the knee joint to aid the surgeon in balancing soft tissue structures during a total knee arthroplasty (TKA).
- Intended use: For use as a tool for adjustment of the femoral knee implant to reduce 4. instability from flexion gap asymmetry. The force sensor is sterile, for single patient use.
- Technological characteristics: The subject device differs from the predicate manual ડ. orthopedic device in that it employs a WIRELESS connection to the digital display unit.
- Performance: Both bench and clinical tests were performed. Bench testing included 6. mechanical testing, radio frequency, and sterility testing. including EO residues. Clinical testing was performed to determine adequacy of instructions for use, the range of patient population, performance characteristics, and reliability. The results were satisfactory and revealed no concerns over safety and effectiveness as compared to predicate devices. The tests demonstrated that the device is as safe, as effective, and performs in a substantially equivalent manner to the predicate device.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract design resembling an eagle or bird-like figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA" is arranged in a circular fashion around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Synvasive Technologies. Incorporated % Michael G. Fisher President and Chief Executive Officer 4925 Robert J. Mathews Pkwy. El Dorado Hills, California 95762

JUL 2 2009

Synvasive Technologies, Incorporated
% Michael G. Fisher
President and Chief Executive Officer
4925 Robert J. Mathews Pkwy.
El Dorado Hills, California 95762

Re: K070108

Trade/Device Name: eLibra Dynamic Knee Balancer Regulation Number: 882.4560 Regulation Name: Sterotaxic instrument Regulatory Class: II Product Code: ONN Dated (Date on orig SE itr): April 4, 2007 Received (Date on orig SE ltr): April 4, 2007

Dear Mr. Fisher:

This letter corrects our substantially equivalent letter of April 4, 2007.

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 (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

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Page 2-Mr. Michael G. Fisher

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/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/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 toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Karbenbuchus

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

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## Indications for Use

510(k) Number (if known):

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications For Use:

For use as a tool for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry. The force sensor is sterile, for single patient use.

Prescription Use _ X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Berbare Buchmo
(Division Sign-Off)

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**510(k) Number** K070108