← Product Code [OLO](/productcode/OLO) · K261024

# TMINI Miniature Robotic System (K261024)

_THINK Surgical, Inc. · OLO · Jul 24, 2026 · Neurology · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K261024

## Device Facts

- **Applicant:** THINK Surgical, Inc.
- **Product Code:** [OLO](/productcode/OLO.md)
- **Decision Date:** Jul 24, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 882.4560
- **Device Class:** Class 2
- **Review Panel:** Neurology
- **Attributes:** Therapeutic

## Indications for Use

The TMINI System (Manual Cleaning), like the predicate is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.

## Device Story

TMINI Miniature Robotic System assists surgeons in TKA procedures; utilizes preoperative CT scans to create 3D bone models for surgical planning; surgeon selects and positions implants on 3D models via TPLAN workstation. Intraoperatively, system uses optical tracking (six-camera overhead console) to register patient anatomy relative to pre-planned landmarks. Hand-held robotic tool articulates in two degrees-of-freedom to place bone pins; mechanical guides attach to pins for subsequent bone cuts and drill guide holes. System provides real-time gap balancing measurements (medial/lateral space in mm). Used in clinical settings; operated by surgeons. Output includes spatial guidance for implant placement; aids in achieving pre-planned orientation and alignment. Benefits include accurate component placement and intraoperative flexibility for plan adjustments.

## Clinical Evidence

Bench testing only. Cleaning validation testing performed on the manual cleaning method met all acceptance criteria. Previous clinical/performance data from predicate K260010 remains applicable as core technology, materials, and design are unchanged.

## Technological Characteristics

Stereotaxic robotic system; includes TPLAN planning workstation, TNav optical tracking console, and hand-held robotic tool. Materials have history of orthopedic use or ISO 10993 compliance. Connectivity: TPLAN workstation for planning/review. Sterilization: Reusable components via manual or automated cleaning. Software: Proprietary implant module generation/verification.

## Regulatory 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

- TMINI Miniature Robotic System ([K260010](/device/K260010.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
> Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/).

{0}

**FDA U.S. FOOD & DRUG**
ADMINISTRATION

July 24, 2026

THINK Surgical, Inc.
Denise Duchene
Director, Regulatory Affairs
47201 Lakeview Blvd.
Fremont, California 94538

Re: K261024

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 27, 2026
Received: March 30, 2026

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.

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"

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

{1}

K261024 - Denise Duchene

Page 2

(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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).

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 Management System Regulation (QMSR) (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-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE

{2}

K261024 - Denise Duchene

Page 3

by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Shumaya Ali -S

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

{3}

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

# **Indications for Use**

Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.

510(k) Number (if known)

K261024

Device Name

TMINI® Miniature Robotic System

Indications for Use (Describe)

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 compatible with and to be used with the following knee replacement systems 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™ 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
- Stryker® Triathlon® Knee 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.**

This section applies only to requirements of the Paperwork Reduction Act of 1995.

**\*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.\***

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

*"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."*

FORM FDA 3881 (6/20)

Page 1 of 1

PSC Publishing Services (301) 443-6740 EF

{4}

THINK®
SURGICAL

TMINI® Miniature Robotic System
Traditional 510(k) Submission

### 510(k) SUMMARY – K261024

Applicant Information:

|  Owner Name: | THINK Surgical, Inc.  |
| --- | --- |
|  Address: | 47201 Lakeview Blvd., Fremont, CA 94538  |
|  Phone number: | 408-921-5648  |
|  Fax number: | 510-249-2396  |
|  Establishment Registration Number: | 3000719653  |
|  Contact Person: | Denise Duchene  |
|  Date Prepared: | 21 July 2026  |

Device Information:

|  Device Classification: | Class II  |
| --- | --- |
|  Trade Name: | TMINI® Miniature Robotic System  |
|  Common name: | Orthopedic Stereotaxic Instrument  |
|  Classification name: | Stereotaxic Instrument  |
|  Regulation number: | 882.4560  |
|  Product Code: | OLO  |

Predicate Device:

The TMINI® Miniature Robotic System (Manual Cleaning) 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 K260010.

Device Modification:

The purpose of this submission is to introduce an alternate manual cleaning method in addition to the current automated method of cleaning the reusable components of the TMINI System and remove the THINK Case Manager (TCM) from the TMINI System as we no longer intend to market this device for business reasons.

Cleaning validation testing was conducted on the manual cleaning method to evaluate the effectiveness of the manual method to properly clean the TMINI Miniature Robotic System. All testing met the acceptance criteria of the testing protocols and demonstrated substantial equivalence to the predicate. The modifications made had no impact on the intended use, Indications for Use,

Page 1 of 8

{5}

THINK®
SURGICAL

TMINI® Miniature Robotic System
Traditional 510(k) Submission

design, materials, technology, or operational principles of the device and no new questions of safety or effectiveness resulted from the changes. Therefore, the TMINI® Miniature Robotic System (Manual Cleaning) is demonstrated to be substantially equivalent to the predicate device cleared via K260010.

### Device Description:

The TMINI® Miniature Robotic System (Manual Cleaning) like its predicate, the TMINI® Miniature Robotic System consists of three primary components: a three-dimensional, graphical, Preoperative Planning Workstation, 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. This has not changed as a result of the addition of the alternate manual cleaning method or the removal of TCM included in this submission. The manual cleaning method does not impact or change the intended use of the TMINI System.

Both the proposed and the predicate device include the TPLAN Planning Station, which 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 optimally place the implant. The surgeon reviews and approves the case plan using TPLAN 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.

In the both the TMINI (Manual Cleaning) and the predicate 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.

### Intended Use:

The TMINI System (Manual Cleaning), like the predicate is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.

Page 2 of 8

{6}

THINK®
SURGICAL

TMINI® Miniature Robotic System
Traditional 510(k) Submission

# Indications for Use:

The Indications for Use of the TMINI® Miniature Robotic System (Manual Cleaning) 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, introduces an alternate manual cleaning method for the reusable components of the TMINI System, and the removal of TCM from the TMINI System.

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 (Manual Cleaning) to the predicate, TMINI® Miniature Robotic System cleared via K260010.

Table 1: Comparison of Intended Use and Indications for Use

|  Product | TMINI® Miniature Robotic System (Manual Cleaning) | TMINI® Miniature Robotic System (TMINI 1.2) | Conclusion  |
| --- | --- | --- | --- |
|  510(k) number | Subject Device | K260010 |   |
|  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 | 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 | 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 | SAME  |

Page 3 of 8

{7}

THINK®
SURGICAL

TMINI® Miniature Robotic System
Traditional 510(k) Submission

|  Product | TMINI® Miniature Robotic System (Manual Cleaning) | TMINI® Miniature Robotic System (TMINI 1.2) | Conclusion  |
| --- | --- | --- | --- |
|   | 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 compatible with and 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 - Stryker® Triathlon® Knee System | 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 compatible with and 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 - Stryker® Triathlon® Knee System |   |

### Substantial Equivalence:

Both the TMINI® Miniature Robotic System (Manual Cleaning), 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.

In both devices, 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 introduces an alternate manual cleaning method for the components of the TMINI System and removes TCM from the system. None of these modifications either

Page 4 of 8

{8}

THINK®
SURGICAL

TMINI® Miniature Robotic System
Traditional 510(k) Submission

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 (Manual Cleaning) 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, which is the subject of the 510(k) submission, introduces an alternate manual cleaning method for the components of the system, and removes TCM from the TMINI System.

There were no changes in the patient contacting components nor their materials of manufacture from the predicate cleared in K260010. Therefore, biocompatibility information for patient contacting materials remains the same as the reviewed in K260010 and no additional biocompatibility testing was required.

Substantial equivalence in technological characteristics and performance of the TMINI® Miniature Robotic System (Manual Cleaning) to the predicate device is outlined in Table-2 below:

Table-2: Substantial Equivalence

|  Product | TMINI® Miniature Robotic System (Manual Cleaning) | TMINI® Miniature Robotic System (TMINI 1.2) | Conclusion  |
| --- | --- | --- | --- |
|  510(k) number | Subject Device | K260010 |   |
|  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 | The major system components remain unchanged. The only difference is the removal of the web-based plan review option. Plans now can only be reviewed on the TPLAN Planning Station. | Planning, web-based plan review, and robot control software, robotic positioning device, navigation system, reusable and disposable instrumentation | Substantially Equivalent  |
|  • 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  |

Page 5 of 8

{9}

THINK®
SURGICAL

TMINI® Miniature Robotic System
Traditional 510(k) Submission

|  Product | TMINI® Miniature Robotic System (Manual Cleaning) | TMINI® Miniature Robotic System (TMINI 1.2) | Conclusion  |
| --- | --- | --- | --- |
|  510(k) number | Subject Device | K260010 |   |
|  Manufacturer | THINK Surgical Inc. | THINK Surgical Inc. |   |
|  • Implant Module creation, verification and validation for each compatible implant system | Proprietary method of generation and verification of new implant modules added to the system. | Proprietary method of generation and verification of new implant modules added to the system. | 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 | Remains unchanged except for removal of TCM for review and approval | Performed by surgeon on either the TPLAN Planning Station or the THINK Case Manager (TCM) | Substantially Equivalent  |
|  • 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 | Remains unchanged e. | 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  |
|  • Cut guide positioning | Robotic device places bone pins in the correct plane, then cutguide or drill block is attached to the pins and bone | Robotic device places bone pins in the correct plane, then cutguide 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  |
|  • Cleaning Method | Automated cleaning using an automated washer and manual cleaning using a validated manual washing method. | Automated cleaning using an automated washer | Substantially Equivalent  |

Page 6 of 8

{10}

THINK®
SURGICAL

TMINI® Miniature Robotic System
Traditional 510(k) Submission

|  Product | TMINI® Miniature Robotic System (Manual Cleaning) | TMINI® Miniature Robotic System (TMINI 1.2) | Conclusion  |
| --- | --- | --- | --- |
|  510(k) number | Subject Device | K260010 |   |
|  Manufacturer | THINK Surgical Inc. | THINK Surgical Inc. |   |
|  • 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 - Stryker® Triathlon® Knee 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 - Stryker® Triathlon® Knee System | SAME  |
|  Performance Testing |  |  |   |
|  Full System Run Through Testing | Unchanged | Passed | SAME  |
|  Cutting Accuracy • Pin & Block Placement Accuracy • Cadaver Lab Validation Testing • System Gap Balance Accuracy | Unchanged Unchanged Unchanged | Passed Passed Passed | SAME SAME SAME  |
|  User Needs Validation Testing | Unchanged | Passed | SAME  |
|  Usability Testing | Unchanged | Passed | SAME  |
|  System Software Testing | Passed | Passed | SAME  |
|  Implant System Module Generation, Verification & Validation Testing | Unchanged | Passed | SAME  |
|  *Biocompatibility Testing |  |  |   |
|  • Cytotoxicity | *Unchanged | Passed | SAME  |
|  • Sensitization | *Unchanged | Passed | SAME  |
|  • Intracutaneous Reactivity | *Unchanged | Passed | SAME  |
|  • Acute Systemic Toxicity | *Unchanged | Passed | SAME  |
|  • Pyrogenicity | *Unchanged | Passed | SAME  |

* There are no material changes to any of the direct patient contact components of the TMINI® Miniature Robotic System 1.2 from the predicate as a result of modifications included in this submission; therefore, no additional biocompatibility testing is required.

Page 7 of 8

{11}

THINK®
SURGICAL

TMINI® Miniature Robotic System
Traditional 510(k) Submission

# Non-Clinical Performance Testing:

Cleaning validation was conducted on the alternate manual cleaning method to evaluate performance during use with the TMINI System. All testing met the acceptance criteria of the testing protocols and demonstrated substantial equivalence to the predicate. The modifications made had no impact on the intended use, Indications for Use, design, materials, technology, or operational principles of the device and no new questions of safety or effectiveness resulted from the changes.

Risk assessment was performed on the device in accordance with ISO 14971:2019 and THINK Surgical Risk Management procedures. Changes were assessed separately and in the aggregate through risk analysis and appropriate performance testing to evaluate the impact of the change. No new risks have been identified. The existing 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 K260010.

# Conclusion

The TMINI® Miniature Robotic System (Manual Cleaning) is substantially equivalent to the predicate, TMINI® Miniature Robotic System (K260010), 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.

Performance testing and risk analysis has demonstrated that the performance and risk profile of the TMINI® Miniature Robotic System (Manual Cleaning) is substantially equivalent to 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 (Manual Cleaning) to the legally marketed TMINI® Miniature Robotic System cleared via K260010.

Page 8 of 8

---

**Source:** [https://fda-staging.innolitics.com/device/K261024](https://fda-staging.innolitics.com/device/K261024)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com