(88 days)
No.
Here's the reasoning: The document does not mention "AI," "DNN," or "ML" within its text. The functions described (spatial boundaries, orientation, reference information, software-defined guidance, pre-operative planning using CT scans, robotic assistance for precise implant placement) can be achieved through traditional programming and control systems without necessarily employing AI models. The system relies on predefined surgical plans and tracked anatomical landmarks, which falls under robotics and navigation, not explicitly AI.
Yes.
The device is a stereotaxic instrumentation system that assists surgeons in total knee replacement surgery by providing guidance for the accurate placement of knee implant components, which is a therapeutic intervention.
No
The device is a stereotaxic instrumentation system that assists the surgeon by providing software-defined spatial boundaries and reference information for the accurate placement of knee implant components. It is a surgical assistance tool, not a diagnostic device used to identify a condition or disease.
No
The device description clearly outlines hardware components: a Preoperative Planning Workstation, an Optical Tracking Navigation Console, and a robotically controlled hand-held tool. The system physically assists the surgeon in preparing bone and placing pins, which are hardware functions, not solely software.
No.
The device is a surgical robotic system used during knee replacement surgery to assist in implant placement by providing guidance and controlled movement. It does not perform in vitro examination of specimens derived from the human body.
N/A
Intended Use / Indications for Use
Intended Use: The TMINI Miniature Robotic System (Software Modifications) like the predicate TMINI Miniature Robotic System is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.
Indications for Use: The TMINI® Miniature Robotic System is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon by providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components.
The robotic device placement is performed relative to anatomical landmarks as recorded using the system intraoperatively and based on a surgical plan determined preoperatively using CT based surgical planning tools.
The targeted population has the same characteristics as the population that is suitable for the implant(s) compatible with the TMINI® Miniature Robotic System.
The TMINI® Miniature Robotic System is to be used with the following knee replacement system(s) in accordance with the indications and contraindications:
- Enovis™ EMPOWR Knee System®
- Ortho Development BKS® and BKS TriMax® Knee System
- Total Joint Orthopedics Klassic® Knee System
- United U2™ Knee Total Knee System
- Medacta® GMK® Sphere / SpheriKA Knee Systems
- Zimmer Biomet Anterior & Posterior Referencing Persona® Knee
- b-ONE MOBIO® Total Knee System
- Maxx Orthopedics Freedom® Total & Titan Knee
- LINK® LinkSymphoKnee System
Product codes (comma separated list FDA assigned to the subject device)
OLO
Device Description
The TMINI® Miniature Robotic System (Software Modifications) like its predicate, the TMINI® Miniature Robotic System consists of three primary components: a three-dimensional, graphical, Preoperative Planning Workstation (TPLAN® Planning Station) including THINK Case Manager (TCM) the web-based method for surgeons to review, approve and download approved surgical plans, an Optical Tracking Navigation Console (TNav) and a robotically controlled hand-held tool (TMINI Robot) that assists the surgeon in preparing the bone for implantation of TKA components.
The TPLAN Planning Station uses preoperative CT scans of the operative leg to create 3D surface models for case templating and intraoperative registration purposes. The Planning Workstation contains a library of 510(k) cleared knee replacement implant(s) available for use with the system. The surgeon can select an implant model from this library. The planner/surgeon can manipulate the 3D representation of the implant in relation to the bone model to place the implant. The surgeon reviews and approves the case plan using either TPLAN or the TCM web-based application once the surgeon is satisfied with the implant selection, location and orientation. The data from the approved plan is written to a file that is used to guide the robotically controlled hand-held tool.
The hand-held robotic tool is optically tracked relative to optical markers placed in both the femur and tibia and articulates in two degrees-of-freedom, allowing the user to place bone pins in a planar manner in both bones. Mechanical guides are clamped to the bone pins, resulting in subsequent placement of cut slots and drill guide holes such that the distal femoral and proximal tibial cuts can be made in the pre-planned positions and orientations, and such that the implant manufacturer's multi-planer cutting block can be placed relative to drilled distal femoral pilot holes. If the surgeon needs to change the plan during surgery, it can be changed intraoperatively using TNav.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scans
Anatomical Site
Knee, Femur, Tibia
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon / Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Testing to verify the function of the subject device was conducted following the same test methods and acceptance criteria as those used for the predicate device. The testing demonstrated that the TMINI® Miniature Robotic System met all test criteria and specifications. Testing is identified in Table 2 below.
Full System Run Through Testing
Pin & Block Placement Accuracy
Cadaver Lab Validation Testing
System Gap Balance Accuracy
User Needs Validation Testing
Usability Testing
Software Testing
Cytotoxicity
Sensitization
Intracutaneous Reactivity
Acute Systemic Toxicity
Pyrogenicity
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Full System Run Through Testing: Passed
- Cutting Accuracy - Pin & Block Placement Accuracy: Passed
- Cutting Accuracy - Cadaver Lab Validation Testing: Reanalyzed data passed
- Cutting Accuracy - System Gap Balance Accuracy: Passed
- User Needs Validation Testing: Passed
- Usability Testing: Passed
- Software Testing: Passed
- Biocompatibility Testing: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Pyrogenicity - Passed. (Note: These tests were carried over from the predicate device K232802 as no material changes to direct patient contact components occurred).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.4560 Stereotaxic instrument.
(a)
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.(b)
Classification. Class II (performance standards).
FDA 510(k) Clearance Letter - TMINI Miniature Robotic System
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
June 20, 2025
THINK Surgical, Inc.
Denise Duchene
Director, Regulatory Affairs
47201 Lakeview Blvd
Fremont, California 94538
Re: K250877
Trade/Device Name: TMINI Miniature Robotic System
Regulation Number: 21 CFR 882.4560
Regulation Name: Stereotaxic Instrument
Regulatory Class: Class II
Product Code: OLO
Dated: March 21, 2025
Received: March 24, 2025
Dear Denise Duchene:
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 (the 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 available 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.
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K250877 - Denise Duchene
Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-
Page 3
K250877 - Denise Duchene
Page 3
assistance/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,
Tejen D. Soni -S
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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Indications for Use
Submission Number (if known)
K250877
Device Name
TMINI Miniature Robotic System
Indications for Use (Describe)
The TMINI® Miniature Robotic System is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon by providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components.
The robotic device placement is performed relative to anatomical landmarks as recorded using the system intraoperatively and based on a surgical plan determined preoperatively using CT based surgical planning tools.
The targeted population has the same characteristics as the population that is suitable for the implant(s) compatible with the TMINI® Miniature Robotic System.
The TMINI® Miniature Robotic System is to be used with the following knee replacement system(s) in accordance with the indications and contraindications:
- Enovis™ EMPOWR Knee System®
- Ortho Development BKS® and BKS TriMax® Knee System
- Total Joint Orthopedics Klassic® Knee System
- United U2™ Knee Total Knee System
- Medacta® GMK® Sphere / SpheriKA Knee Systems
- Zimmer Biomet Anterior & Posterior Referencing Persona® Knee
- b-ONE MOBIO® Total Knee System
- Maxx Orthopedics Freedom® Total & Titan Knee
- LINK® LinkSymphoKnee System
Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Page 1 of 1.
Page 5
TMINI® Miniature Robotic System
Traditional 510(k) Submission
510(k) SUMMARY - K250877
Applicant Information:
- Owner Name: THINK Surgical Inc.
- Address: 47201 Lakeview Blvd., Fremont, CA94538
- Phone Number: 860-481-5113
- Fax Number: 510-249-2396
- Establishment Registration Number: 3000719653
- Contact Person: Denise Duchene
- Date Prepared: 7 April 2025
Device Information:
- Device Classification: Class II
- Trade Name: TMINI® Miniature Robotic System
- Common Name: Orthopedic Stereotaxic Instrument
- Regulation Number: 882.4560
- Product Code: OLO
Predicate Device:
The TMINI® Miniature Robotic System is substantially equivalent in intended use, Indications for Use, design, materials, technology, operational principles and performance to the predicate, TMINI® Miniature Robotic System, cleared via K243481.
Device Modification:
The purpose of this submission is to introduce modifications to the TMINI® Miniature Robotic System, which includes data logging updates, report updates to open-source software, software enhancements to improve tibial registration performance, and cybersecurity updates. Additional logging has been incorporated into the software logs, and tibial registration has been optimized to increase the success rate of registration while maintaining the same level of performance.
Device Description:
The TMINI® Miniature Robotic System (Software Modifications) like its predicate, the TMINI® Miniature Robotic System consists of three primary components: a three-dimensional, graphical, Preoperative Planning Workstation (TPLAN® Planning Station) including THINK Case Manager (TCM) the web-based method for surgeons to review, approve and download approved surgical plans, an Optical Tracking Navigation Console (TNav) and a robotically controlled hand-held tool (TMINI Robot) that assists the surgeon in preparing the bone for implantation of TKA components.
The TPLAN Planning Station uses preoperative CT scans of the operative leg to create 3D surface models for case templating and intraoperative registration purposes. The Planning Workstation contains a library of 510(k) cleared knee replacement implant(s) available for
K250877, Page 1 of 8
Page 6
TMINI® Miniature Robotic System
Traditional 510(k) Submission
use with the system. The surgeon can select an implant model from this library. The planner/surgeon can manipulate the 3D representation of the implant in relation to the bone model to place the implant. The surgeon reviews and approves the case plan using either TPLAN or the TCM web-based application once the surgeon is satisfied with the implant selection, location and orientation. The data from the approved plan is written to a file that is used to guide the robotically controlled hand-held tool.
The hand-held robotic tool is optically tracked relative to optical markers placed in both the femur and tibia and articulates in two degrees-of-freedom, allowing the user to place bone pins in a planar manner in both bones. Mechanical guides are clamped to the bone pins, resulting in subsequent placement of cut slots and drill guide holes such that the distal femoral and proximal tibial cuts can be made in the pre-planned positions and orientations, and such that the implant manufacturer's multi-planer cutting block can be placed relative to drilled distal femoral pilot holes. If the surgeon needs to change the plan during surgery, it can be changed intraoperatively using TNav.
Intended Use:
The TMINI Miniature Robotic System (Software Modifications) like the predicate TMINI Miniature Robotic System is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.
Indications for Use:
The Indications for Use of the TMINI® Miniature Robotic System (Software Modifications) and the predicate are the same (See Table 1). Both describe the use of a system that uses diagnostic imaging of the patient to allow a surgeon to plan and execute orthopedic total knee procedures. The only difference is that the device, that is the subject of this 510(k) submission, provides updated data logging, reports on updates to open-source software, improves the pass rate for tibial registration, and provides updates for cybersecurity.
None of the changes made to the predicate, nor the aggregate of all changes, have altered the indications for use, nor have they raised new types of safety or effectiveness questions.
Tables 1 and 2, below identify the substantial equivalence of the TMINI® Miniature Robotic System (Software Modifications) to the predicate, TMINI® Miniature Robotic System cleared via K243481.
K250877, Page 2 of 8
Page 7
TMINI® Miniature Robotic System
Traditional 510(k) Submission
K250877, Page 3 of 8
Table 1: Comparison of Intended Use and Indications for Use
| Product | TMINI® Miniature Robotic System (Software Modifications) | TMINI® Miniature Robotic System | Conclusion |
|---|---|---|---|
| 510(k) number | Subject Device | K243481 | |
| Manufacturer | THINK Surgical, Inc | THINK Surgical, Inc | |
| Product Code | OLO | OLO | SAME |
| Regulation | 21 CFR 882.4560 | 21 CFR 882.4560 | SAME |
| Intended Use | Intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. | Intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. | SAME |
| Indications for Use | The TMINI® Miniature Robotic System is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon by providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components. |
The robotic device placement is performed relative to anatomical landmarks as recorded using the system intraoperatively and based on a surgical plan determined preoperatively using CT based surgical planning tools.
The targeted population has the same characteristics as the population that is suitable for the implant(s) compatible with the TMINI® Miniature Robotic System.
The TMINI® Miniature Robotic System is to be used with the following knee replacement system(s) in accordance with the indications and contraindications:
- Enovis™ EMPOWR Knee System®
- Ortho Development BKS® and BKS TriMax® Knee System
- Total Joint Orthopedics Klassic® Knee System | The TMINI® Miniature Robotic System is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon by providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components.
The robotic device placement is performed relative to anatomical landmarks as recorded using the system intraoperatively and based on a surgical plan determined preoperatively using CT based surgical planning tools.
The targeted population has the same characteristics as the population that is suitable for the implant(s) compatible with the TMINI® Miniature Robotic System.
The TMINI® Miniature Robotic System is to be used with the following knee replacement system(s) in accordance with the indications and contraindications:
- Enovis™ EMPOWR Knee System®
- Ortho Development BKS® and BKS TriMax® Knee System
- Total Joint Orthopedics Klassic® Knee System | SAME |
Page 8
TMINI® Miniature Robotic System
Traditional 510(k) Submission
Table 1: Comparison of Intended Use and Indications for Use
| Product | TMINI® Miniature Robotic System (Software Modifications) | TMINI® Miniature Robotic System | Conclusion |
|---|---|---|---|
| 510(k) number | Subject Device | K243481 | |
| Manufacturer | THINK Surgical, Inc | THINK Surgical, Inc | |
| Product Code | OLO | OLO | SAME |
| Regulation | 21 CFR 882.4560 | 21 CFR 882.4560 | SAME |
| Intended Use | Intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. | Intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. | SAME |
| Indications for Use | The TMINI® Miniature Robotic System is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon by providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components. |
The robotic device placement is performed relative to anatomical landmarks as recorded using the system intraoperatively and based on a surgical plan determined preoperatively using CT based surgical planning tools.
The targeted population has the same characteristics as the population that is suitable for the implant(s) compatible with the TMINI® Miniature Robotic System.
The TMINI® Miniature Robotic System is to be used with the following knee replacement system(s) in accordance with the indications and contraindications:
- Enovis™ EMPOWR Knee System®
- Ortho Development BKS® and BKS TriMax® Knee System
- Total Joint Orthopedics Klassic® Knee System
- United U2™ Knee Total Knee System
- Medacta® GMK® Sphere / SpheriKA Knee Systems
- Zimmer Biomet Anterior & Posterior Referencing Persona® Knee
- b-ONE MOBIO® Total Knee System
- Maxx Orthopedics Freedom® Total & Titan Knee
- LINK® LinkSymphoKnee System | The TMINI® Miniature Robotic System is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon by providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components.
The robotic device placement is performed relative to anatomical landmarks as recorded using the system intraoperatively and based on a surgical plan determined preoperatively using CT based surgical planning tools.
The targeted population has the same characteristics as the population that is suitable for the implant(s) compatible with the TMINI® Miniature Robotic System.
The TMINI® Miniature Robotic System is to be used with the following knee replacement system(s) in accordance with the indications and contraindications:
- Enovis™ EMPOWR Knee System®
- Ortho Development BKS® and BKS TriMax® Knee System
- Total Joint Orthopedics Klassic® Knee System
- United U2™ Knee Total Knee System
- Medacta® GMK® Sphere / SpheriKA Knee Systems
- Zimmer Biomet Anterior & Posterior Referencing Persona® Knee
- b-ONE MOBIO® Total Knee System
- Maxx Orthopedics Freedom® Total & Titan Knee
- LINK® LinkSymphoKnee System | SAME |
K250877, Page 3 of 8
Page 9
TMINI® Miniature Robotic System
Traditional 510(k) Submission
| Product | TMINI® Miniature Robotic System (Software Modifications) | TMINI® Miniature Robotic System | Conclusion |
|---|---|---|---|
| - United U2™ Knee Total Knee System |
- Medacta® GMK® Sphere / SpheriKA Knee Systems
- Zimmer Biomet Anterior & Posterior Referencing Persona® Knee
- b-ONE MOBIO® Total Knee System
- Maxx Orthopedics Freedom® Total & Titan Knee
- LINK® LinkSymphoKnee System | - United U2™ Knee Total Knee System
- Medacta® GMK® Sphere / SpheriKA Knee Systems
- Zimmer Biomet Anterior & Posterior Referencing Persona® Knee
- b-ONE MOBIO® Total Knee System
- Maxx Orthopedics Freedom® Total & Titan Knee
- LINK® LinkSymphoKnee System | |
Substantial Equivalence:
Both the TMINI® Miniature Robotic System (Software Modifications), the subject of this submission, and the predicate device have the same intended use. Both are indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon by providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components during orthopedic procedures.
The robotic device placement is performed relative to anatomical landmarks as recorded using the system intraoperatively and based on a surgical plan determined preoperatively using CT-based surgical planning tools. The difference between the new device and the predicate is that the new device provides updated data logging, report on updates to open-source software, improves the pass rate for tibial registration, and provides updates for cybersecurity. None of these changes, either individually or in the aggregate, alter the intended use, Indications for Use, design, materials, technology, or operational principles of the TMINI® Miniature Robotic System and no new questions of safety or effectiveness resulted from the changes.
The Indications for Use of the TMINI Miniature Robotic System (Software Modifications) and the predicate are the same (See Table 1). Both describe the use of a system that uses diagnostic imaging of the patient to allow a surgeon to plan and execute orthopedic total knee procedures. The only difference is that the device subject to this 510(k) submission provides updated software logs, reports on updates to open-source software, improves the pass rate for tibial registration, and includes cybersecurity updates.
Testing to verify the function of the subject device was conducted following the same test methods and acceptance criteria as those used for the predicate device. The testing demonstrated that the TMINI® Miniature Robotic System met all test criteria and specifications. Testing is identified in Table 2 below.
Biocompatibility information for patient contacting materials and testing for the TMINI Miniature Robotic System were presented in predicate device submission K232802. There are no material changes to any of the direct patient contact components of the TMINI®
K250877, Page 4 of 8
Page 10
TMINI® Miniature Robotic System
Traditional 510(k) Submission
K250877, Page 5 of 8
Miniature Robotic System as a result of the software modifications included in this submission; therefore, no additional biocompatibility testing was required.
Substantial equivalence in technological characteristics and performance of the TMINI® Miniature Robotic System to the predicate device is outlined in Table-2 below:
Table-2: Substantial Equivalence
| Product | TMINI® Miniature Robotic System (Software Modifications) | TMINI® Miniature Robotic System | Conclusion |
|---|---|---|---|
| 510(k) number | Subject Device | K243481 | |
| Manufacturer | THINK Surgical Inc. | THINK Surgical Inc. | |
| Materials | |||
| • Materials Used | Uses materials with a long history of use in orthopedic procedures or provided biocompatibility data consistent with ISO 10993 requirements | Uses materials with a long history of use in orthopedic procedures or provided biocompatibility data consistent with ISO 10993 requirements | SAME |
| Technological Characteristics | |||
| • Major System Components | Planning, web-based plan review, and robot control software, robotic positioning device, navigation system, reusable and disposable instrumentation | Planning, web-based plan review, and robot control software, robotic positioning device, navigation system, reusable and disposable instrumentation | SAME |
| • Patient Imaging | CT images used to create a 3D model of the bone for surgical planning | CT images used to create a 3D model of the bone for surgical planning | SAME |
| • Preoperative planning workstation | TPLAN three-dimensional preoperative planning workstation | TPLAN three-dimensional preoperative planning workstation | SAME |
| • Surgical planning system | Technician guided surgical planning with surgeon review and approval on a desktop planning station | Technician guided surgical planning with surgeon review and approval on a desktop planning station | SAME |
| • Surgical planning review, approval, and approved plan export or download | Performed by surgeon on either the TPLAN Planning Station or the THINK Case Manager (TCM) | Performed by surgeon on either the TPLAN Planning Station or the THINK Case Manager (TCM) | SAME |
| • Bone Marker Arrays for bone registration and tracking | Active markers on femur and tibia mounted onto the bones via an attachment assembly | Active markers on femur and tibia mounted onto the bones via an attachment assembly | SAME |
| • Surgical Exposure | Similar to traditional surgical exposure | Similar to traditional surgical exposure | SAME |
| • Patient/Robot Registration | Preoperatively determined landmarks are compared to intraoperatively identified landmarks to complete patient bone registration | Preoperatively determined landmarks are compared to intraoperatively identified landmarks to complete patient bone registration | SAME |
| • Camera Tracking Technology | Six camera overhead tracking with a wide-angle field of view | Six camera overhead tracking with a wide-angle field of view | SAME |
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TMINI® Miniature Robotic System
Traditional 510(k) Submission
| Product | TMINI® Miniature Robotic System (Software Modifications) | TMINI® Miniature Robotic System | Conclusion |
|---|---|---|---|
| 510(k) number | Subject Device | K243481 | |
| Manufacturer | THINK Surgical Inc. | THINK Surgical Inc. | |
| • Cut guide positioning | Robotic device places bone pins in the correct plane, then cut guide or drill block is attached to the pins and bone | Robotic device places bone pins in the correct plane, then cut guide or drill block is attached to the pins and bone | SAME |
| • Intraoperative planning changes | Implant position can be fully adjusted, allowing deviation from the intended implant positioning philosophy and implant size | Implant position can be fully adjusted, allowing deviation from the intended implant positioning philosophy and implant size | SAME |
| • Bone Preparation Technique | A surgical saw is used to cut the bone through a cut guide | A surgical saw is used to cut the bone through a cut guide | SAME |
| • Intraoperative Anatomic Measurements | The tracked bone arrays and bone registration data are used to determine the knee flexion angle and varus/valgus laxity | The tracked bone arrays and bone registration data are used to determine the knee flexion angle and varus/valgus laxity | SAME |
| • Gap Balancing | Displays the maximum space in the medial and lateral compartments in millimeters with the knee in extension and in flexion allowing the surgeon to perform gap balancing, if desired | Displays the maximum space in the medial and lateral compartments in millimeters with the knee in extension and in flexion allowing the surgeon to perform gap balancing, if desired | SAME |
| • TKA Component Implantation Technique | Implants are secured to the bone, either with or without cement using standard surgical technique provided by the implant manufacturer | Implants are secured to the bone, either with or without cement using standard surgical technique provided by the implant manufacturer | SAME |
| • Compatible Knee Implant Systems | - Enovis™ EMPOWR Knee System® |
- Ortho Development® BKS® and BKS TriMax® Knee System
- Total Joint Orthopedics Klassic® Knee System
- United® U2™ Knee System
- Medacta® GMK® Sphere / SpheriKA Knee Systems
- Zimmer Biomet Anterior & Posterior Referencing Persona® Knee
- b-ONE MOBIO® Total Knee System
- Maxx Orthopedics Freedom® Total & Titan Knee
- LINK® LinkSymphoKnee System | - Enovis™ EMPOWR Knee System®
- Ortho Development® BKS® and BKS TriMax® Knee System
- Total Joint Orthopedics Klassic® Knee System
- United® U2™ Knee System
- Medacta® GMK® Sphere / SpheriKA Knee Systems
- Zimmer Biomet Anterior & Posterior Referencing Persona® Knee
- b-ONE MOBIO® Total Knee System
- Maxx Orthopedics Freedom® Total & Titan Knee
- LINK® LinkSymphoKnee System | SAME |
K250877, Page 5 of 8
Page 12
TMINI® Miniature Robotic System
Traditional 510(k) Submission
| Product | TMINI® Miniature Robotic System (Software Modifications) | TMINI® Miniature Robotic System | Conclusion |
|---|---|---|---|
| 510(k) number | Subject Device | K243481 | |
| Manufacturer | THINK Surgical Inc. | THINK Surgical Inc. | |
| • Cut guide positioning | Robotic device places bone pins in the correct plane, then cut guide or drill block is attached to the pins and bone | Robotic device places bone pins in the correct plane, then cut guide or drill block is attached to the pins and bone | SAME |
| • Intraoperative planning changes | Implant position can be fully adjusted, allowing deviation from the intended implant positioning philosophy and implant size | Implant position can be fully adjusted, allowing deviation from the intended implant positioning philosophy and implant size | SAME |
| • Bone Preparation Technique | A surgical saw is used to cut the bone through a cut guide | A surgical saw is used to cut the bone through a cut guide | SAME |
| • Intraoperative Anatomic Measurements | The tracked bone arrays and bone registration data are used to determine the knee flexion angle and varus/valgus laxity | The tracked bone arrays and bone registration data are used to determine the knee flexion angle and varus/valgus laxity | SAME |
| • Gap Balancing | Displays the maximum space in the medial and lateral compartments in millimeters with the knee in extension and in flexion allowing the surgeon to perform gap balancing, if desired | Displays the maximum space in the medial and lateral compartments in millimeters with the knee in extension and in flexion allowing the surgeon to perform gap balancing, if desired | SAME |
| • TKA Component Implantation Technique | Implants are secured to the bone, either with or without cement using standard surgical technique provided by the implant manufacturer | Implants are secured to the bone, either with or without cement using standard surgical technique provided by the implant manufacturer | SAME |
| • Compatible Knee Implant Systems | - Enovis™ EMPOWR Knee System® |
- Ortho Development® BKS® and BKS TriMax® Knee System
- Total Joint Orthopedics Klassic® Knee System
- United® U2™ Knee System
- Medacta® GMK® Sphere / SpheriKA Knee Systems
- Zimmer Biomet Anterior & Posterior Referencing Persona® Knee
- b-ONE MOBIO® Total Knee System
- Maxx Orthopedics Freedom® Total & Titan Knee
- LINK® LinkSymphoKnee System | - Enovis™ EMPOWR Knee System®
- Ortho Development® BKS® and BKS TriMax® Knee System
- Total Joint Orthopedics Klassic® Knee System
- United® U2™ Knee System
- Medacta® GMK® Sphere / SpheriKA Knee Systems
- Zimmer Biomet Anterior & Posterior Referencing Persona® Knee
- b-ONE MOBIO® Total Knee System
- Maxx Orthopedics Freedom® Total & Titan Knee
- LINK® LinkSymphoKnee System | SAME |
K250877, Page 6 of 8
Page 13
TMINI® Miniature Robotic System
Traditional 510(k) Submission
| Product | TMINI® Miniature Robotic System (Software Modifications) | TMINI® Miniature Robotic System | Conclusion |
|---|---|---|---|
| 510(k) number | Subject Device | K243481 | |
| Manufacturer | THINK Surgical Inc. | THINK Surgical Inc. | |
| Performance Testing | |||
| Full System Run Through Testing | Passed | Passed | SAME |
| Cutting Accuracy | SAME | ||
| • Pin & Block Placement Accuracy | **Passed | Passed | |
| • Cadaver Lab Validation Testing | Reanalyzed data passed | Passed | |
| • System Gap Balance Accuracy | **Passed | Passed | |
| User Needs Validation Testing | **Passed | Passed | SAME |
| Usability Testing | **Passed | Passed | SAME |
| Software Testing | Passed | Passed | SAME |
| *Biocompatibility Testing | |||
| • Cytotoxicity | *Passed | Passed | SAME |
| • Sensitization | *Passed | Passed | SAME |
| • Intracutaneous Reactivity | *Passed | Passed | SAME |
| • Acute Systemic Toxicity | *Passed | Passed | SAME |
| • Pyrogenicity | *Passed | Passed | SAME |
* There are no material changes to any of the direct patient contact components of the TMINI® Miniature Robotic System as a result of software modifications included in this submission; therefore, no additional biocompatibility testing was required.
** These tests did not need to be repeated as a result of the changes to the software included in this submission.
Risk assessment was performed on the device in accordance with ISO 14971:2019 and THINK Surgical Risk Management procedures. Each change was assessed separately and in the aggregate through risk analysis and appropriate performance testing to evaluate the impact of the change. Risk analysis resulted in the identification of no new instances of risk, no new clinical hazards, and no new questions of safety or effectiveness as a result of these changes. Risks have been mitigated to acceptable levels and there is no change in the overall risk profile of the device compared to the predicate cleared in K243481.
Conclusion
The TMINI® Miniature Robotic System (Software Modifications) is substantially equivalent to the predicate, TMINI® Miniature Robotic System (K243481), in the following ways:
• it has the same intended use,
• it has the same Indication for Use,
• it has the same technological characteristics and operating principles and incorporates the same design and materials.
Testing and risk analysis has demonstrated that the performance and risk profile of the TMINI® Miniature Robotic System (Software Modifications) is substantially equivalent to
K250877, Page 7 of 8
Page 14
TMINI® Miniature Robotic System
Traditional 510(k) Submission
that of the predicate device and does not raise any new question of safety and effectiveness.
THINK Surgical Inc. respectfully submits that this filing contains adequate information and data to demonstrate the substantial equivalence of the TMINI® Miniature Robotic System (Software Modifications) to the legally marketed TMINI® Miniature Robotic System cleared via K243481.
K250877, Page 8 of 8