(22 days)
Not Found
No
The summary describes a robotic surgical system for knee replacement that uses CT scans for preoperative planning and optical tracking for intraoperative guidance. It does not mention any use of AI or ML for image processing, planning, or robotic control. The system relies on surgeon input and pre-defined parameters.
No
This device is a surgical assistance system that helps the surgeon by providing guidance and precise placement of components during total knee replacement surgery. It does not directly treat a disease or condition in a therapeutic way.
No.
The device is described as a surgical assistance system for total knee replacement surgery that helps with accurate placement of knee implant components, not for diagnosing medical conditions.
No
The device description explicitly states that the system consists of three primary components: a Preoperative Planning Workstation (software), an Optical Tracking Navigation Console (likely hardware and software), and a robotically controlled hand-held tool (hardware and software). The description details the function of the robotic tool and its interaction with the patient's anatomy, indicating a significant hardware component beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The TMIN® Miniature Robotic System is a surgical guidance system used during total knee replacement surgery. It assists the surgeon in planning and executing bone cuts and pin placements based on pre-operative imaging and a surgical plan.
- No Sample Analysis: The device does not analyze any biological samples from the patient. Its function is entirely focused on providing spatial guidance and reference information within the surgical field.
The device utilizes medical imaging (CT scans) and software for planning and navigation, but this is distinct from the analysis of biological samples that defines an IVD.
N/A
Intended Use / 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 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
Product codes
OLO
Device Description
Like its predicate, the TMINI® 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) and a robotically controlled hand-held tool (TMINI Robot) that assists the surgeon in preparing the bone for implantation of TKA components.
The TPLAN Planning Station uses preoperative CT scans of the operative leg to create 3D surface models for case templating and intraoperative registration purposes. The Planning Workstation contains a library of 510(k) cleared knee replacement implant(s) available for use with the system. The surgeon can select an implant model from this library. The planner/surgeon can manipulate the 3D representation of the implant in relation to the bone model to 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scans
Anatomical Site
Knee
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon, hospital setting (inferred from "surgical planning")
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)
Performance Testing:
- Full System Run: Passed
- Cutting Accuracy: Passed
- Pin & Block Placement Accuracy: Passed
- Cadaver Lab Validation Testing: Passed
- System Gap Balance Accuracy: Passed
Biocompatibility Testing (for patient contacting materials):
- Cytotoxicity: Passed
- Sensitization: Passed
- Intracutaneous Reactivity: Passed
- Acute Systemic Toxicity: Passed
- Pyrogenicity: Passed
Risk assessment was performed on the device in accordance with ISO 14971:2019 and THINK Surgical Risk Management procedures. The risk assessment was comprised of analysis and mitigation of the risks associated with the addition of three compatible knee implant systems. The risk assessment resulted in the identification of no new clinical hazards. Each of the clinical hazards identified through this risk assessment is a previously documented hazard associated with the use of the TMINI® Miniature Robotic System. The addition of three new implant systems does not increase the likelihood or severity of these hazards; therefore, the risks associated with the use of the device remain unchanged as compared to the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).
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) | |
|---|---|
| ☑ 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 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.
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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) | Substantial
Equivalence
Conclusion |
| 510(k) number | Subject Device | K241031 | |
| Manufacturer | THINK Surgical Inc. | THINK Surgical Inc. | |
| -Intraoperative planning
changes | Implant position can be fully
adjusted, allowing deviation
from the intended implant
positioning philosophy and
implant size | Implant position can be fully
adjusted, allowing deviation
from the intended implant
positioning philosophy and
implant size | SAME |
| -Bone Preparation
Technique | A surgical saw is used to
cut the bone through a cut
guide | A surgical saw is used to
cut the bone through a cut
guide | SAME |
| -Intraoperative Anatomic
Measurements | The tracked bone arrays
and bone registration data
are used to determine the
knee flexion angle and
varus/valgus laxity | The tracked bone arrays
and bone registration data
are used to determine the
knee flexion angle and
varus/valgus laxity | SAME |
| -Gap Balancing | Displays the maximum
space in the medial and
lateral compartments in
millimeters with the knee in
extension and in flexion
allowing the surgeon to
perform gap balancing, if
desired. | Displays the maximum
space in the medial and
lateral compartments in
millimeters with the knee in
extension and in flexion
allowing the surgeon to
perform gap balancing, if
desired. | SAME |
| -TKA Component
Implantation Technique | Implants are secured to the
bone, either with or without
cement using standard
surgical technique provided
by the implant manufacturer | Implants are secured to the
bone, either with or without
cement using standard
surgical technique provided
by the implant manufacturer | SAME |
| -Compatible Knee
Implant Systems | - Enovis™ EMPOWR Knee
System®
-Ortho Development® BKS®
and BKS TriMax® Knee
System
-Total Joint Orthopedics
Klassic® Knee System
-United® U2TM Knee
System
-Medacta® GMK® Sphere /
SpheriKA Knee Systems
-Zimmer Biomet Anterior &
Posterior Referencing
Persona® Knee | - Enovis™ EMPOWR Knee
System®
-Ortho Development® BKS®
and BKS TriMax® Knee
System
-Total Joint Orthopedics
Klassic® Knee System
-United® U2TM Knee
System | Substantially
Equivalent
(addition of two
new implant
systems) |
| Performance Testing | | | |
| -Full System Run | Passed | Passed | SAME |
| 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. | |
| Cutting Accuracy
-Pin & Block Placement
Accuracy
-Cadaver Lab Validation
Testing
-System Gap Balance
Accuracy | Passed | Passed | SAME |
| *Biocompatibility
Testing | | | |
| -Cytotoxicity | *Passed | Passed | SAME |
| -Sensitization | *Passed | Passed | SAME |
| -Intracutaneous
Reactivity | *Passed | Passed | SAME |
| -Acute Systemic Toxicity | *Passed | Passed | SAME |
| -Pyrogenicity | *Passed | Passed | SAME |
Table 1: Comparison of Intended Use and Indications for Use
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Image /page/6/Picture/1 description: The image shows the logo for Think Surgical. The logo features a stylized letter 'T' in blue, with the top part of the 'T' forming a semi-circle. Below the 'T', the word 'THINK' is written in a bold, sans-serif font, with the 'I' replaced by a vertical line. Underneath 'THINK', the word 'SURGICAL' is written in a smaller, sans-serif font.
Substantial Equivalence:
Both the TMINI® Miniature Robotic System (Additional Knee System), the subject of this submission, and the predicate device have the same intended use. Both are indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon by providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components during orthopedic procedures.
The robotic device placement is performed relative to anatomical landmarks as recorded using the system intraoperatively and based on a surgical plan determined preoperatively using CT based surgical planning tools. The difference between the new device and the predicate is that the new device includes compatibility with two additional knee systems. The addition of the two knee systems do not alter the intended use, Indications for Use (other than the addition of the two new implant systems), 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 new device and its predicate are identical except for the addition of the two new implant systems to the list of compatible implant systems and the removal of the sentence listing the system components.
Verification and validation activities were performed to ensure that the TMINI® Miniature Robotic System (Additional Knee System) fulfilled system requirements, ensure that the product design conforms to the user needs and intended uses and performs substantially equivalent to the predicate, TMINI™ Miniature Robotic System, cleared via K241031. Throughout all testing performed, test samples were representative of the production product. The verification and validation activities for the TMINI® Miniature Robotic System (Additional Knee System) followed test protocols that were previously established and reviewed in the 510(k) submissions for the predicate device. The verification and validation activities were successfully completed, and all pre-determined acceptance criteria were met.
Biocompatibility information for patient contacting materials and testing for the TMINI® Miniature Robotic System were presented in submission K232802. There are no material changes to any of the direct patient contact components of the TMINI® Miniature Robotic
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Image /page/7/Picture/0 description: The image shows the logo for Think Surgical. The logo features a stylized letter 'T' with a blue circle at the top, resembling a surgical tool. Below the 'T', the word 'THINK' is written in bold, dark gray letters, and below that, the word 'SURGICAL' is written in smaller, lighter gray letters.
System (Additional Knee System) included in this submission; therefore, no additional biocompatibility testing was required.
Substantial equivalence in technological characteristic and performance of the TMINI® Miniature Robotic System to the predicate device is outlined in Table-2 below:
Table-2: Substantial Equivalence
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Image /page/8/Picture/0 description: The image is a logo for Think Surgical. The logo features a blue sphere with a white reflection at the top, resembling a stylized "T". Below the sphere is the word "THINK" in a bold, sans-serif font, with the "I" represented by a thin, vertical line extending from the sphere above. Underneath "THINK" is the word "SURGICAL" in a smaller, sans-serif font.
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Image /page/9/Picture/0 description: The image shows the logo for Think Surgical. The logo features a stylized letter "T" in blue, with a needle-like shape extending downwards from the center of the "T". Below the "T" is the word "THINK" in a sans-serif font, and below that is the word "SURGICAL" in a smaller font.
- There are no material changes to any of the direct patient contact components of the TMIN® Miniature Robotic System (Additional Knee System) as a result of Additional Knee System included in this submission; therefore, no additional biocompatibility testing was required.
Risk assessment was performed on the device in accordance with ISO 14971:2019 and THINK Surgical Risk Management procedures. The risk assessment was comprised of analysis and mitigation of the risks associated with the addition of three compatible knee implant systems. The risk assessment resulted in the identification of no new clinical hazards. Each of the clinical hazards identified through this risk assessment is a previously documented hazard associated with the use of the TMINI® Miniature Robotic System. The addition of three new implant systems does not increase the likelihood or severity of these hazards; therefore, the risks associated with the use of the device remain unchanged as compared to the predicate.
Conclusion
The TMINI® Miniature Robotic System (Additional Knee System) is substantially equivalent to the predicate. TMINI™ Miniature Robotic System cleared in K241031, in the following ways: it has the same intended use, 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 TMIN® Miniature Robotic System (Additional Knee System) 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 TMIN® Miniature Robotic System (Additional Knee System) to the legally marketed TMINI™ Miniature Robotic System cleared via K241031.