(90 days)
No
The description focuses on traditional robotic assistance, optical tracking, and pre-operative planning based on CT scans. There is no mention of AI or ML algorithms for tasks like image analysis, surgical planning optimization, or real-time decision support.
No.
The indicated use of the device is for surgical assistance, specifically to help surgeons accurately place knee implant components. It does not directly treat or prevent a disease, but rather aids in a surgical procedure.
No
This device is designed to assist in surgical procedures (total knee replacement) by providing guidance for accurate implant placement and bone preparation. It uses preoperative CT scans for planning and intraoperative navigation to ensure precise execution of the surgical plan, rather than diagnosing a condition.
No
The device description explicitly states it includes a handheld robotic device, an optical sensor navigation system, and surgical instruments, in addition to the software system. This indicates it is a hardware and software system, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The TMINI™ Miniature Robotic System is a surgical guidance system used during total knee replacement surgery. It assists the surgeon in the physical placement of bone pins and guides for cutting, based on preoperative planning using CT images. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it is a "stereotaxic instrumentation system for total knee replacement (TKA) surgery" to "assist the surgeon by providing software-defined spatial boundaries for orientation and reference information." This is a surgical tool, not a diagnostic test.
Therefore, the TMINI™ Miniature Robotic System falls under the category of a surgical robotic system or computer-assisted surgery system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Indications for Use (Describe)
TMINITM 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 TMINITM Miniature Robotic System. The TMINITM Miniature Robotic System is to be used with the following knee replacement system(s) in accordance with the indications and contraindications: EnovisTM EMPOWR Knee System®.
Intended Use
The TMINITM 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.
Product codes
OLO
Device Description
The TMINITM 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. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT
Anatomical Site
Knee joint (femur and tibia)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, Hospital
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Biocompatibility: Passed
- Cutting Accuracy: Equivalent or better than manual instrumentation
§ 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).
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)
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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. | Substantially
Equivalent
(Both systems use bone
markers for registration
and tracking of motion
TMINI uses active
markers, while Rosa
uses passive markers) |
| -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 |
| 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) | |
| Camera Tracking Technology | Six camera overhead tracking with a wide angle field of view | Two camera sideways tracking with traditional field of view | Substantially Equivalent
(Both systems provide intraoperative tracking required for robotic control and patient tracking) |
| -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 a cut guide or drill block in the correct plane, then bone pins are used to secure the guide or block to the bone. | Substantially Equivalent
(Both systems use robotic control to place the cut guides to execute the TKA procedure - TMINI places the bone pins under robot control and then attaches the cut guide to the pins, while Rosa places the cut guide in the correct plane using the robot arm and then drills the pins to secure the guide) |
| - Intraoperative planning changes | Implant position can be adjusted along bone axis only, preserving the intended implant positioning philosophy. | Implant position can be fully adjusted, allowing deviation from the intended implant positioning philosophy. | Substantially Equivalent
(Both systems allow for some degree of intraoperative adjustment of the surgical plan) |
| -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 |
| -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 |
| 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) | |
| Performance
Testing | | | |
| -Biocompatibility | Passed | Passed | SAME |
| -Cutting Accuracy | Equivalent or better than
manual instrumentation