Who is the manufacturer of TMINI Miniature Robotic System?

THINK Surgical, Inc. filed the 510(k) submission for TMINI Miniature Robotic System (K230202).

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: Traditional).

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

K230202 · THINK Surgical, Inc. · OLO · Apr 25, 2023 · Neurology

Device Facts

Record ID	K230202
Device Name	TMINI Miniature Robotic System
Applicant	THINK Surgical, Inc.
Product Code	OLO · Neurology
Decision Date	Apr 25, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.4560
Device Class	Class 2

Intended Use

The 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.

Device Story

TMINI™ Miniature Robotic System assists surgeons in TKA procedures. Inputs: preoperative CT scans for 3D bone modeling and intraoperative optical tracking of femur/tibia. Operation: Preoperative planning workstation creates 3D models for implant templating; intraoperative navigation console tracks bone markers; handheld robotic tool articulates in two degrees-of-freedom to place bone pins. Output: Guided placement of bone pins for subsequent attachment of cutting/drill guides. Used in OR by surgeons. Benefits: Provides software-defined spatial boundaries for accurate implant component placement relative to anatomical landmarks.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing, including biocompatibility, cutting accuracy (< 0.5mm RMSE), cadaver lab validation, software verification/validation, and electromagnetic compatibility/electrical safety testing.

Technological Characteristics

System components: TPLAN Planning Station (desktop), TNav Optical Tracking Console, and handheld robotic tool. Materials: long history of use in orthopedics. Sensing: optical tracking with six-camera overhead system. Connectivity: not specified. Sterilization: not specified. Software: 3D planning and robotic control.

Indications for Use

Indicated for total knee replacement (TKA) surgery as a stereotaxic instrumentation system. Assists surgeons by providing software-defined spatial boundaries for orientation and reference to anatomical structures for accurate knee implant placement. Used with Enovis™ EMPOWR Knee System® in patients suitable for the compatible implant.

Regulatory Classification

Identification

A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.

Predicate Devices

Rosa Knee System (K182964)

Related Devices

K232802 — TMINI Miniature Robotic System · THINK Surgical, Inc. · Oct 12, 2023
K242264 — TMINI Miniature Robotic System · THINK Surgical, Inc. · Aug 23, 2024
K243285 — TMINI Miniature Robotic System · THINK Surgical, Inc. · Nov 15, 2024
K253661 — TMINI Miniature Robotic System · THINK Surgical, Inc. · Dec 22, 2025
K241031 — TMINI Miniature Robotic System (TMINI 1.1) · THINK Surgical, Inc. · Jul 12, 2024

Submission Summary (Full Text)

{0}------------------------------------------------ April 25, 2023 Image /page/0/Picture/1 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. THINK Surgical, Inc. Meliha Mulalic VP, Regulatory Affairs and Quality Assurance 47201 Lakeview Boulevard Fremont, California 94538 Re: K230202 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: January 24, 2023 Received: January 25, 2023 Dear Meliha Mulalic: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's {1}------------------------------------------------ requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) #### K230202 Device Name TMINITM 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. 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 the indications and contraindications: Enovis™ EMPOWR Knee System®. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| X 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." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Think Surgical. The logo consists of the word "THINK" in a bold, sans-serif font, with a blue vertical line in the middle of the "I". Below the word "THINK" is the word "SURGICAL" in a smaller, sans-serif font. The logo is simple and modern, and the blue line adds a touch of color and visual interest. # 510(k) SUMMARY # Applicant Information: | Owner Name: | THINK Surgical, Inc. | |------------------------------------|-----------------------------------------| | Address: | 47201 Lakeview Blvd., Fremont, CA 94538 | | Phone number: | 510-249-2337 | | Fax number: | 510-249-2396 | | Establishment Registration Number: | 3000719653 | | Contact Person: | Meliha Mulalic | | Date Prepared: | January 24, 2023 | ### Device Information: | Device Classification: | Class II | |------------------------|-----------------------------------| | Trade Name: | TMINI™ Miniature Robotic System | | Common name: | Orthopedic Stereotaxic Instrument | | Classification name: | Stereotaxic Instrument | | Regulation number: | 21 CFR 882.4560 | | Product Code: | OLO | ## Predicate Device: The TMINI™ Miniature Robotic System is substantially equivalent in intended use, fundamental scientific technology and performance to the following legally marketed device in commercial distribution: Rosa Knee System cleared by the FDA through K182964. ## Device Description: The TMINI™ Miniature Robotic System consists of three primary components: a three-dimensional, graphical, Preoperative Planning Workstation (TPLAN Planning Station), 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. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Think Surgical. The logo consists of the word "THINK" in a bold, sans-serif font, with the "I" replaced by a blue, elongated triangle. Below the word "THINK" is the word "SURGICAL" in a smaller, sans-serif font. The logo is simple and modern, and the blue triangle adds a touch of color and visual interest. 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). The surgeon can select an implant model from this library and manipulate the 3D representation of the implant in relation to the bone model to optimally place the implant. Once the surgeon is satisfied with the implant location and orientation, the data is written to a file that is used to guide the robotically controlled hand-held tool. The handheld 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. ### Intended Use The 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 he 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 their indications and contraindications: Enovis™ EMPOWR Knee System®. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Think Surgical. The logo consists of the word "THINK" in a sans-serif font, with the "I" in "THINK" being a blue vertical line. Below the word "THINK" is the word "SURGICAL" in a smaller sans-serif font. ### Substantial Equivalence: The TMINI™ Miniature Robotic System, is substantially equivalent to the predicate Rosa Knee System cleared by FDA through K182964. The subject device has the same intended use as the predicate device and substantially equivalent indications for use, materials, technology and operational principles. Both the TMINI™ Miniature Robotic System and the predicate, Rosa Knee System, consist of three primary components; a planning workstation or online planning application, an optical tracking system and a robotically controlled device that assists the surgeon in preparing the bone for implantation of the TKA components. Both Systems use three-dimensional (3D) preoperative planning software that aids the surgeon in planning the position and orientation of the implant components relative to 3D models of the patient's anatomy. Both the TMINI™ Miniature Robotic System and the predicate, Rosa Knee System, use a robotic device with a tracking array that guides the surgeon in preparing the bone for implantation of the total knee components consistent with the planned surgical procedure. The tools and accessories that are used to accomplish total knee arthroplasty are the same or substantially equivalent to those used for conventional TKA procedures without robotic control. These include various instrumentation both reusable and disposable: surgical drapes, drills, saw blades, probes, bone pins, and cut and drill guides. The substantial equivalence of the TMINI™ Miniature Robotic System is supported by equivalence in materials, technology and operational principals, and performance testing which supports the safety and substantial equivalence of the device for use in TKA. | Product | TMINI™ Miniature Robotic System | Rosa Knee System | Conclusion | |------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) number | PENDING | K182964 | | | Manufacturer | Think Surgical, Inc | Orthosoft Inc. (d/b/a Zimmer CAS) | | | 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 | | Product 510(k) number | TMINI™ Miniature Robotic System | Rosa Knee System | Conclusion | | Manufacturer | Think Surgical, Inc | Orthosoft Inc. (d/b/a Zimmer CAS) | | | 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. 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 their indications and contraindications: Enovis TM EMPOWR Knee System®. | The Rosa® 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, optionally determined preoperatively using compatible X-ray or MRI based surgical planning tools. It includes a robotic arm, 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 Rosa® Knee System. The Rosa Knee System is to be used with the following fixed bearing knee replacement systems in accordance with their indications and contraindication: NexGen® CR, NexGen CR-Flex, NexGen CR- Flex Gender, NexGen LPS, NexGen LPS-Flex, NexGen LPS-Flex Gender, Persona CR, Persona® CR, Persona PS, Vanguard® CR and Vanguard CR | Substantially Equivalent (1) Both systems have a pre- surgical planning module – while Rosa can also be used intraoperatively without a pre- surgical plan. (2) Both systems use radiographic imaging — TMINI uses CT imaging while Rosa uses either X-ray or MRI imaging. (3) Both systems have a robotic device that assists with surgical preparation - the TMIN robotic device is handheld while the Rosa has a robotic arm. (4) Both devices are used only with their stated compatible implant systems | | Product | TMINI™ Miniature Robotic System | Rosa Knee System | Conclusion | | 510(k) number | Pending | K182964 | | | Manufacturer | Think Surgical Inc | Orthosoft Inc. (d/b/a Zimmer CAS) | | | Materials | | | | | -Materials Used | Uses materials with a long history of use in orthopedic procedures. | Uses materials with a long history of use in orthopedic procedures. | 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 | | -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 via an online review application | Substantially Equivalent (Both systems have a surgical planning system – TMINI has a desktop planning station, while Rosa uses an online application) | | -Pre-surgical Imaging | CT images used to create a 3D model of the bone for surgical planning | MRI or X-ray used to create 3D model of the bone for pre-operative planning | Substantially Equivalent (Both systems use radiographic imaging to create 3D bone models - TMINI uses CT and Rosa uses X-ray or MRI) | | -Surgical Exposure | Similar to traditional surgical exposure | Similar to traditional surgical exposure | SAME | | -Bone Marker Arrays for bone registration and tracking | Active markers on femur and tibia mounted onto the bones via an attachment assembly. | Passive reflective markers on femur and tibia mounted onto the bones via an attachment assembly.…