XO1 Knee Balancing System

K162237 · Xpandortho, Inc. · ONN · Apr 25, 2017 · Neurology

Device Facts

• Record ID: K162237
• Device Name: XO1 Knee Balancing System
• Applicant: Xpandortho, Inc.
• Product Code: ONN · Neurology
• Decision Date: Apr 25, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4560
• Device Class: Class 2

Intended Use

The XO1 Knee Balancing System is intended for use as a tool for adjustment of soft tissue to reduce instability from flexion gap asymmetry in total knee replacement procedures.. The XO1 Knee Balancing System requires a resected tibial bone and may only be used with an intact femur, trial femoral implant. The force sensor is sterile, for single patient use.

Device Story

XO1 Knee Balancing System functions as intraoperative tool for total knee arthroplasty; assists surgeons in balancing soft tissues to address flexion gap asymmetry. System utilizes force sensor to measure soft tissue tension; provides quantitative feedback to surgeon during procedure. Used in operating room environment by orthopedic surgeons. Device requires resected tibial bone and trial femoral implant for operation. Sterile, single-use force sensor provides real-time data; enables surgeon to make informed adjustments to soft tissue, potentially improving joint stability and patient outcomes post-surgery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

System includes sterile, single-use force sensor. Operates as intraoperative measurement tool for soft tissue tension in total knee replacement. Connectivity and software details not specified.

Indications for Use

Indicated for patients undergoing total knee replacement procedures requiring soft tissue adjustment to reduce instability caused by flexion gap asymmetry. Requires resected tibial bone and intact femur with trial femoral implant.

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.

Submission Summary (Full Text)

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

April 25, 2017

Xpandortho, Inc. Rebecca Pine Official Correspondent 2223 Avenida De La Playa Suite 203 La Jolla, California 92037-3218

Re: K162237

Trade/Device Name: XO1 Knee Balancing System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: ONN Dated: August 3, 2016 Received: August 9, 2016

Dear Rebecca Pine:

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Mark N. Melkerson -S

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

Enclosure

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## Indications for Use

510(k) Number (if known) K162237

Device Name X01 Knee Balancing System

Indications for Use (Describe)

The XO1 Knee Balancing System is intended for use as a tool for adjustment of soft tissue to reduce instability from flexion gap asymmetry in total knee replacement procedures.. The XO1 Knee Balancing System requires a resected tibial bone and may only be used with an intact femur, trial femoral implant. The force sensor is sterile, for single patient use.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|----------------|
| Prescription Use (Part 21 CFR 801 Subpart D) | <span> </span> |
| Over-The-Counter Use (21 CFR 801 Subpart C) | <span> </span> |

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