TrueBalance™ Surgical System
Device Facts
| Record ID | K220830 |
|---|---|
| Device Name | TrueBalance™ Surgical System |
| Applicant | These Three Medical, LLC |
| Product Code | ONN · Neurology |
| Decision Date | Sep 15, 2022 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.4560 |
| Device Class | Class 2 |
Indications for Use
TrueBalance™ Surgical System is indicated for any medical condition in which primary or revision Total Knee Arthroplasty (TKA) would be indicated. For use as a tool to measure implant alignment and for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry. TrueBalance™ Surgical System is completely reusable with the exception of the Ultra-Thin Force Sensor which is single use.
Device Story
TrueBalance™ Surgical System is an intraoperative orthopedic joint assessment tool used by surgeons during TKA. It measures dynamic loads in medial/lateral knee compartments and static angular alignment of bone cuts. Inputs include force data from an Ultra-Thin Force Sensor and orientation data from an embedded accelerometer. The system transforms these inputs into numerical and pictorial load/alignment data, transmitted via Bluetooth to an iPad running the TrueBalance™ Software Application (TSA). The surgeon uses this real-time feedback to adjust femoral implant positioning and balance flexion gaps, aiming to reduce post-operative instability. The system is implant-agnostic and reusable, except for the single-use force sensor. All hardware components (excluding the iPad) are steam-sterilizable. The device provides quantifiable data to assist in surgical decision-making, potentially improving implant alignment and joint stability.
Clinical Evidence
No clinical data. Substantial equivalence demonstrated via bench testing, including software lifecycle validation (IEC 62304), electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), sterilization validation, biocompatibility (ISO 10993), shelf-life/packaging testing, and performance testing for load/force and alignment accuracy.
Technological Characteristics
Materials: VICTREX 450G PEEK, silicone gasket. Sensing: Capacitive load sensors, accelerometer. Energy: Internal 3.6V lithium battery. Connectivity: Bluetooth 4.2 to iPad. Form factor: Modular, autoclavable components. Software: TSA application on iOS. Sterilization: Steam autoclave. Standards: IEC 60601-1, IEC 60601-1-2, ISO 10993, ISO 17665, IEC 62304.
Indications for Use
Indicated for patients undergoing primary or revision 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
Submission Summary (Full Text)
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September 15, 2022
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These Three Medical, LLC Moj Eram Regulatory Affairs Correspondent 20860 N. Tatum Blvd.. Suite 300 Phoenix, Arizona 85050
Re: K220830
Trade/Device Name: TrueBalance™ Surgical System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: ONN Dated: August 15, 2022 Received: August 16, 2022
Dear Moj Eram:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For: Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number (if known) K220830
Device Name TrueBalance™ Surgical System
Indications for Use (Describe)
TrueBalance™ Surgical System is indicated for any medical condition in which primary or revision Total Knee Arthroplasty (TKA) would be indicated.
For use as a tool to measure implant alignment of the femoral knee implant to reduce instability from flexion gap asymmetry. TrueBalance™ Surgical System is completely reusable with the exception of the Ultra-Thin Force Sensor which is single use.
Type of Use (Select one or both, as applicable)
| <span> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
|-----------------------------------------------------------------------------------------------------|
| <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
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Image /page/3/Picture/1 description: The image shows the logo for These Three Medical, LLC. The logo features a blue circle with three curved lines emanating from it, resembling a signal or sound wave. To the right of the symbol, the words "THESE THREE" are written in a bold, sans-serif font, with "MEDICAL, LLC" written in a smaller font below.
# 510(k) Summary
# 21 CFR 807.92(a)
#### 1 General Provisions
| Submitter Name: | These Three Medical, LLC |
|----------------------|------------------------------------------------------|
| Address: | 20860 N. Tatum Blvd., Suite 300<br>Phoenix, AZ 85050 |
| Contact Person: | Jay Pierce |
| Telephone Number: | 480.771.4133 |
| Date of Preparation: | 15 August 2022 |
#### Principle and Regulatory Contacts 2
### Submitted By/Principal Contact:
| Contact Name: | Jay Pierce |
|---------------|------------------------------------------------------|
| Title: | President/CEO<br>These Three Medical, LLC |
| Address: | 20860 N. Tatum Blvd., Suite 300<br>Phoenix, AZ 85050 |
| Phone Number: | 480.771.4133 |
| Email: | huan@generalvibronics.com |
### Regulatory Affairs Correspondance:
| Name: | Moj Eram, PhD |
|---------------|-----------------------------------|
| Title: | Regulatory Affairs Representative |
| | Sage BioPartners, LLC |
| Phone Number: | 801.230.8611 (Mobile) |
| Email: | moj.eram@sagebiopartners.com |
#### 3 Subject Device
| Trade Name: | TrueBalance™ Surgical System |
|-------------------------------|------------------------------|
| Classification Name: | Stereotaxic Instrument |
| Classification: | Class II |
| Product Code: | ONN |
| Regulation Number: | 21 CFR 822.4560 |
| Regulation Medical Specialty: | Neurology |
| Review Panel: | Orthopedic |
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#### Predicate Devices ব
- 1. VERASENSE For Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE For Zimmer Biomet Persona CR C-D/3-9 Right, VERASENSE For Zimmer Biomet Persona CR E-F/3-11 Left, VERASENSE For Zimmer Biomet Persona CR E-F/3-11 Right, VERASENSE For Zimmer Biomet Persona CR G-H/7-12 Left (hereafter VERASENSE For Zimmer Biomet Persona)
| Manufacturer: | OrthoSensor, Inc. |
|-------------------------------|------------------------------------------------|
| 510(k) Number: | K193580 |
| Classification: | Class II |
| FDA Product Code: | ONN (Subsequent OLO) |
| Regulation Number: | 21 CFR 882.4560 |
| Regulation Medical Specialty: | Neurology |
| Review Panel: | Orthopedic |
| Device Classification Name: | Intraoperative Orthopedic Joint Assessment Aid |
#### VERASENSE For Zimmer Biomet Persona 2.
| Manufacturer: | OrthoSensor, Inc. |
|----------------------------------------------------------------------------|-------------------|
| 510(k) Number: | K180459 |
| Classification: | Class II |
| FDA Product Code: | ONN |
| Regulation Number: | 21 CFR 882.4560 |
| Regulation Medical Specialty: | Neurology |
| Review Panel: | Orthopedic |
| Device Classification Name: Intraoperative Orthopedic Joint Assessment Aid | |
#### 5 Device Description
TrueBalance™ Surgical System provides a means to measure implant alignment and dynamically balance the knee during primary or revision Total Knee Arthroplasty (TKA).
TrueBalance™ Surgical System consists of seven components and one optional component:
- Electronic Module, 1.
- 2. Ultra-Thin Force Sensor,
- Multifunction Alignment Handle, 3.
- 4. Sensor Covers (8 sizes),
- 5. Alignment Rod,
- Sterilization Tray, and 6.
- 7. TrueBalance™ Software Application (TSA) and Display (iPad)
- 8. (Optional) Off-the-shelf Tablet Floor Stand for iPad
The TrueBalance™ Surgical System Electronic Module and hardware components are steam sterilizable via autoclave and reusable via a Sterilization Tray. TrueBalance™ Surgical System
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Ultra-Thin Force Sensor is single use, packaged non-sterilizable via autoclaye. The TrueBalance™ Surgical System Electronic Module is steam sterilizable via autoclave in either the Sterilization Tray or standard autoclavable pouches.
TrueBalance™ Surgical System measures dynamic loads in the medial and lateral compartments of the knee and static angular measurements for the alignment functionality. The data from the Ultra-Thin Force Sensor and embedded accelerometer is wirelessly transmitted to the TrueBalance™ Software Application (TSA) and Display (iPad) which is located outside the sterile field in the operating room.
#### Indications for Use 6
TrueBalance™ Surgical System is indicated for any medical condition in which primary or revision Total Knee Arthroplasty (TKA) would be indicated.
For use as a tool to measure implant alignment and for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry. TrueBalance™ Surgical System is completely reusable with the exception of the Ultra-Thin Force Sensor which is single use.
#### 7 Comparison of Technological Characteristics with the Predicate Devices
A comparison of the subject device. TrueBalance™ Surgical System and predicate devices. VERASENSE For Zimmer Biomet Persona (K193580) & VERASENSE For Zimmer Biomet Persona (K180459), is based on the following same technologies:
- . Electronics and sensors to measure load/force pressure between the femur and tibia in TKA procedures.
- . Electronics and accelerometer to measure coronal plane alignment of the tibial resection relative to the patient specific tibia reference axis defined by the system registered landmarks, and numerical value of the varus/valgus tibial mechanical axis.
- Required components to support the system includes a device that communicates via Bluetooth communications and a software application.
- Algorithms to calculate medial and lateral load pressures and present to a user interface. ●
- Sensor covers (shims) for thickness. ●
In addition to the similarities stated above, the following technological differences exist between the subject device, TrueBalance™ Surgical System and Predicate devices, VERASENSE For Zimmer Biomet Persona (K193580) & (K180459):
- . The Predicate device measures condylar load/force only when the trial hardware components are placed while the TrueBalance™ Surgical System measures condylar loading during gap balancing and trialling phase.
- TrueBalance Surgical System utilizes a Multifunctional Alignment Handle to measure ● load/force in the medial and lateral compartments, along with load positions in the anterior and posterior compartments.
- In addition to measuring the resected the tibia, TrueBalance Surgical System utilizes an accelerometer and 21inch Alignment Rod to measure coronal plane alignment of the femoral resection relative to the patient specific femur reference axis defined by the
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system registered landmarks, and numerical value of the varus/valgus femoral mechanical axis. Note that most conventional instrumentation for TKA procedures includes a spacer block and alignment rod in order to provide the surgeon a tool for visual interpretation of post cut limb alignment, albeit without quantifiable data.
- TrueBalance™ Software Application (TSA) and Display (iPad) presents tibia slope and . mechanical axis of the limb.
- . The Predicate devices enclose all electronics and sensors in a plastic, hermetically sealed, single use component. The TrueBalance Surgical System electronics module is decoupled from the sensor and the multifunction alignment handle. The system requires assembly in the operating room.
- . The Ultra-Thin Force Sensor fits directly between the Multifunction Alignment Handle and numerous size Sensor Covers and is placed between the Femur and resected Tibia with or without trial hardware.
- . The entire TrueBalance Surgical System (excluding TSA) is autoclavable.
- TrueBalance Surgical System is reusable. (Exception is the Ultra-thin Force Sensor which . single use)
- The TrueBalance™ Surgical System is implant company agnostic system and not dependent on the dimensions of OEM implant components.
- . The Predicate devices provide a separate computer (link station) that houses the Software Application. TrueBalance™ Software Application (TSA) and Display (iPad) is provided to the hospital as part of a complete system.
| Table 5.1 - Subject and Predicate devices Comparison | | | | |
|----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| | Subject Device<br>TrueBalance™ Surgical System | Predicate Device<br>VERASENSE for Zimmer<br>Biomet Persona<br>(K193580) | Predicate Device<br>VERASENSE for Zimmer<br>Biomet Persona<br>(K180459) | |
| Sponsor / Owner | These Three Medical, LLC | OrthoSensor, Inc. | OrthoSensor, Inc. | |
| Regulation<br>Number | 21 CFR 882.4560 | 21 CFR 882.4560 | 21 CFR 882.4560 | |
| Product Code | ONN | ONN<br>Subsequent OLO | ONN | |
| Environment for<br>Use | Hospital (operating room) | Hospital (operating room) | Hospital (operating room) | |
| Intended User | Surgeon | Surgeon | Surgeon | |
| General Device<br>Description | A measurement tool to provide the<br>surgeon with quantifiable data<br>relative to load and angular<br>measurements. | A measurement tool to<br>provide the surgeon with<br>quantifiable data relative to<br>load and angular<br>measurements. | A measurement tool to<br>provide the surgeon with<br>quantifiable data relative to<br>load measurements. | |
| Table 5.1 – Subject and Predicate devices Comparison | | | | |
| | Subject Device<br>TrueBalance™ Surgical System | Predicate Device<br>VERASENSE for Zimmer<br>Biomet Persona<br>(K193580) | Predicate Device<br>VERASENSE for Zimmer<br>Biomet Persona<br>(K180459) | |
| Principle of<br>Operation | A measurement system used to<br>collect quantifiable data that is<br>useful to the surgeon performing<br>Total Knee Arthroplasty (TKA)<br>procedures.<br>Capacitive sensors on the device<br>measure the pressure exerted by the<br>femoral component of the implant<br>on the sensor.<br>The components include an<br>Electronic Module, Ultra-Thin<br>Force Sensor, Sensor Covers<br>(various thicknesses), Multifunction<br>Alignment Handle, Alignment Rod,<br>and an iPad with a Software<br>Application. The load sensors on the<br>device, measure the pressures<br>exerted between the cut femur and<br>tibia and between the femoral<br>component of the implant on the<br>sensor. The embedded<br>accelerometer works in conjunction<br>with the Alignment Rod and is<br>placed in specified procedural<br>positions, in order to measure angles<br>associated with bone cuts.<br>The Electronic Module is connected<br>via Bluetooth to an iPad hosting the<br>TrueBalance™ Software<br>Application (TSA). The TSA<br>displays both numerically and<br>pictorially load data along with<br>angular measurements (alignment<br>data), according to the description<br>and specifications. | A measurement system used<br>to collect quantifiable data<br>that is useful to the surgeon<br>performing Total Knee<br>Arthroplasty (TKA)<br>procedures.<br>Capacitive sensors on the<br>device measure the pressure<br>exerted by the femoral<br>component of the implant on<br>the sensor.<br>The VERASENSE Software<br>Application calculates force<br>vectors and positional data,<br>display both numerically and<br>pictorially load data versus<br>position, according to the<br>description and<br>specifications.<br>Transceiver is connected to<br>LinkStation via a USB cable.<br>Data from the VERASENSE<br>is wirelessly received by the<br>transceiver at a frequency of<br>401.05-405.55 MHz. The<br>transceiver processes<br>Gaussian Frequency-Shift<br>Keying (GFSK) modulated<br>data. | A measurement system used<br>to collect quantifiable data<br>that is useful to the surgeon<br>performing Total Knee<br>Arthroplasty (TKA)<br>procedures.<br>Capacitive sensors on the<br>device measure the pressure<br>exerted by the femoral<br>component of the implant on<br>the sensor.<br>The VERASENSE Software<br>Application calculates force<br>vectors and positional data,<br>display both numerically and<br>pictorially load data versus<br>position, according to the<br>description and<br>specifications.<br>Transceiver is connected to<br>LinkStation via a USB cable.<br>Data from the VERASENSE<br>is wirelessly received by the<br>transceiver at a frequency of<br>401.05-405.55 MHz. The<br>transceiver processes<br>Gaussian Frequency-Shift<br>Keying (GFSK) modulated<br>data. | |
| Control<br>Mechanism | Microelectronics, sensors and<br>accelerometer to measure the<br>femoral component load and angles<br>of bone cuts. | Microelectronics, capacitive<br>sensors and accelerometer to<br>measure the femoral<br>component load and angles<br>of bone cuts. | Microelectronics, capacitive<br>sensors and accelerometer to<br>measure the femoral<br>component load. | |
| Table 5.1 - Subject and Predicate devices Comparison | | | | |
| | Subject Device<br>TrueBalance™ Surgical System | Predicate Device<br>VERASENSE for Zimmer<br>Biomet Persona<br>(K193580) | Predicate Device<br>VERASENSE for Zimmer<br>Biomet Persona<br>(K180459) | |
| | | Materials | | |
| Electronic Module<br>Top Housing | VICTREX450G Natural PEEK -<br>Material Polyetheretherketone<br>(Electronic Module) | Colored Polycarbonate Resin | Colored Polycarbonate Resin | |
| Electronic Module<br>Bottom Housing | VICTREX450G Natural PEEK -<br>Material Polyetheretherketone<br>(Electronic Module) | Colored Polycarbonate Resin | Colored Polycarbonate Resin | |
| Electronic Module<br>Seal Between Top<br>and Bottom<br>Housing | Silicone Gasket | Loctite | Loctite | |
| Sensor Covers | VICTREX450G Natural PEEK -<br>Material Polyetheretherketone…
