Who is the manufacturer of TMINI Miniature Robotic System?

THINK Surgical, Inc. filed the 510(k) submission for TMINI Miniature Robotic System (K242264).

What is the FDA product code for TMINI Miniature Robotic System?

OLO. It is classified under 21 CFR 882.4560 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for TMINI Miniature Robotic System?

510(k) clearance (submission type: Special).

What are the predicate devices for TMINI Miniature Robotic System?

TMINI® Miniature Robotic System (K241031).

Who can help prepare an FDA 510(k) submission like TMINI Miniature Robotic System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

TMINI Miniature Robotic System

K242264 · THINK Surgical, Inc. · OLO · Aug 23, 2024 · Neurology

Device Facts

Record ID	K242264
Device Name	TMINI Miniature Robotic System
Applicant	THINK Surgical, Inc.
Product Code	OLO · Neurology
Decision Date	Aug 23, 2024
Decision	SESE
Submission Type	Special
Regulation	21 CFR 882.4560
Device Class	Class 2

Intended 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 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

Device Story

TMINI Miniature Robotic System assists surgeons in TKA procedures. Input: preoperative CT scans of patient's leg. Process: TPLAN workstation creates 3D bone models for surgical planning; surgeon selects implant and defines placement. Intraoperatively, optical tracking navigation (TNav) registers patient anatomy relative to preoperative plan. Hand-held robotic tool, tracked via optical markers on femur/tibia, articulates in two degrees-of-freedom to guide bone pin placement. Mechanical guides attach to pins for precise bone cuts and drill holes. Output: software-defined spatial boundaries for implant component placement. Used in OR by surgeons. Benefits: accurate implant placement relative to patient-specific anatomy.

Clinical Evidence

Bench testing only. Verification and validation activities, including full system runs, cutting accuracy, pin/block placement accuracy, and cadaver lab validation, were successfully completed. All pre-determined acceptance criteria were met. Biocompatibility data previously established in K232802; no material changes.

Technological Characteristics

System comprises TPLAN planning workstation, TNav optical tracking console, and hand-held robotic tool. Uses optical markers for registration. Materials have history of orthopedic use or ISO 10993 compliance. Connectivity via system-specific components. Software-defined spatial boundaries for surgical guidance.

Indications for Use

Indicated for patients undergoing total knee replacement (TKA) surgery who are suitable candidates for the compatible knee implant systems listed. Contraindications are those associated with the specific compatible knee replacement systems used.

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

TMINI® Miniature Robotic System (K241031)

Related Devices

K253661 — TMINI Miniature Robotic System · THINK Surgical, Inc. · Dec 22, 2025
K230202 — TMINI Miniature Robotic System · THINK Surgical, Inc. · Apr 25, 2023
K232802 — TMINI Miniature Robotic System · THINK Surgical, Inc. · Oct 12, 2023
K243285 — TMINI Miniature Robotic System · THINK Surgical, Inc. · Nov 15, 2024
K241031 — TMINI Miniature Robotic System (TMINI 1.1) · THINK Surgical, Inc. · Jul 12, 2024

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. August 23, 2024 Think Surgical, Inc. Anand Patel Manager, Regulatory Affairs 47201 Lakeview Blvd Fremont, California 94528 Re: K242264 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: July 31, 2024 Received: August 1, 2024 Dear Anand Patel: 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" {1}------------------------------------------------ # K242264 - Anand Patel (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 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-reportingcombination-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. 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-device-safety/medical-device-reportingmdr-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/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, Image /page/1/Picture/7 description: The image shows the name "Shumaya Ali-S" in a large, clear font. The text is horizontally aligned and appears to be the primary focus of the image. The background is a light color, possibly white or a very pale blue, with a faint watermark-like design that is barely visible behind the text. 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K242264 Device Name TMINI® Miniature Robotic System #### Indications for Use (Describe) TMIN® 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® Mimiature 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 | Type of Use (Select one or both, as applicable) | | |----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------| | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### 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." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Think Surgical. The logo features a stylized letter "T" with a blue sphere at the top and a blue, elongated triangle extending downwards. Below the "T", the word "THINK" is written in a bold, sans-serif font, and below that, the word "SURGICAL" is written in a smaller, sans-serif font. # 510(k) SUMMARY # Applicant Information: | Owner Name: | THINK Surgical, Inc. | |------------------------------------|-----------------------------------------| | Address: | 47201 Lakeview Blvd., Fremont, CA 94538 | | Phone number: | 443-756-9392 | | Fax number: | 510-249-2396 | | Establishment Registration Number: | 3000719653 | | Contact Person: | Anand Patel | | Date Prepared: | 21 August 2024 | | Device Information: | | | Device Classification: | Class II | | Trade Name: | TMINI® Miniature Robotic System | | Common name: | Orthopedic Stereotaxic Instrument | | Classification name: | Stereotaxic Instrument | Requlation number: Product Code: | Predicate Device: | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | The TMINI® Miniature Robotic System (Additional Knee 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 K241031. | 882.4560 OLO ### Device Modification: The purpose of this submission is to add two additional FDA cleared knee implant systems that are compatible with the TMIN® Miniature Robotic System to the Enovis™ EMPOWR Knee System®, Ortho Development® BKS® and BKS TriMax® Knee System, the Total Joint Orthopedics Klassic® Knee System, and the United® U2™ Knee System that is already cleared for use with the device. The two new implant systems are: the Medacta® GMK® Sphere / SpheriKA Knee Systems, and the Zimmer Biomet Anterior & Posterior Referencing Persona® Knee. As part of this change the labeling has been modified to show that the Indications for Use of the device has been updated to include compatibility with these two additional knee implant systems. ### Device Description: Like its predicate, the TMIN® Miniature Robotic System (Additional Knee System) consists of three primary components: a three-dimensional, graphical, Preoperative Planning Workstation (TPLAN Planning Station), an Optical Tracking Navigation Console (TNav) {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for Think Surgical. The logo features the word "THINK" in bold, sans-serif font, with the "I" replaced by a blue, three-dimensional teardrop shape. Above the word "THINK" is the trademark symbol, and below it is the word "SURGICAL" in a smaller font. To the right of the word "THINK" is the registered trademark symbol. 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/surqeon 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 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 quides 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: Like the predicate, the TMIN® Miniature Robotic System (Additional Knee 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 differences between the indications for use of the current device and the predicate are the addition of the two additional knee systems and the removal of the sentence listing the system components. See Table-1 below. The table below identifies the substantial equivalence of TMIN® Miniature Robotic System (Additional Knee System) to the predicate, TMINI™ Miniature Robotic System cleared via K241031. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image is a logo for Think Surgical. The logo features a stylized letter "T" with a blue circle behind it. The words "THINK" and "SURGICAL" are written below the "T" in a sans-serif font. The word "THINK" is in a larger font size than the word "SURGICAL." | Product | TMINI® Miniature Robotic System (Additional Knee System) | TMINI™ Miniature Robotic System | Conclusion | |---------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) number | Subject Device | K241031 | | | Manufacturer | THINK Surgical, Inc | THINK Surgical, Inc | SAME | | Product Code | OLO | OLO | | | 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 | 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. It includes a handheld robotic device, an optical sensor navigation system and accessories, software system, surgical instruments and accessories. 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 | Substantially Equivalent (Adds Compatibility with two additional total knee implant systems and the removal of the sentence listing the system components) | | Product | TMINI® Miniature Robotic System (Additional Knee System) | TMINI™ Miniature Robotic System | Conclusion | | | - 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 | 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 | | | Product | TMINI® Miniature Robotic System (Additional Knee System) | TMINI™ Miniature Robotic System (TMINI 1.1) | Substantial Equivalence Conclusion | | 510(k) number | Subject Device | K241031 | | | 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 and robot control software, robotic positioning device, navigation system, reusable and disposable instrumentation | Planning 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 | | -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 | | -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 | | Product | TMINI® Miniature Robotic System (Additional Knee System) | TMINI™ Miniature Robotic System (TMINI 1.1)…