(30 days)
Not Found
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 device is a robotic system designed to assist surgeons during total knee replacement surgery by providing guidance and precision for implant placement. It does not directly treat a disease or condition itself, but rather aids in a surgical procedure performed by a healthcare professional.
No
The TMINI™ Miniature Robotic System is described as a stereotaxic instrumentation system to assist surgeons during total knee replacement surgery by providing guidance for accurate implant placement. It uses preoperative CT scans for surgical planning and intraoperative navigation but does not diagnose conditions.
No
The device description explicitly states that the TMINI™ Miniature Robotic System consists of three primary components: a Preoperative Planning Workstation (software), an Optical Tracking Navigation Console (hardware), and a Robotically Controlled Hand-held Tool (hardware). It is a system that includes both software and hardware components.
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 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 making bone cuts.
- Lack of Biological 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 based on pre-operative imaging and intraoperative anatomical landmarks.
The device is a surgical robotic system intended for use in the operating room to aid in a surgical procedure, not to perform diagnostic testing on biological samples.
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.
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 systems in accordance with the indications and contraindications:
- Enovis™ EMPOWR Knee System®
- Ortho Development® BKS® and BKS TriMax® Knee System
- Total Joint Orthopedics Klassic® Knee System
- United® U2™ Knee Total Knee System
Product codes
OLO
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.
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 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 quide 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 based surgical planning tools, CT scans
Anatomical Site
Knee, Femur, Tibia
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeon
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 to verify the cutting accuracy of the subject device was conducted following similar test methods and acceptance criteria to those used for the predicate device. This testing demonstrated that the TMINI™ Miniature Robotic System met all test criteria and specifications. Validation testing, with methods and acceptance criteria similar to that used for the predicate device, was conducted using simulated surgical testing in a cadaver model and all test criteria were met.
Biocompatibility testing was provided to assess these materials and included: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity and Pyrogenicity. All 5 tests passed the acceptance criteria of the test protocol.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Passed (for performance testing, cadaver lab validation testing, and biocompatibility testing including Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, and Pyrogenicity)
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
October 12, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo 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. Anand Patel Manager, Regulatory Affairs 47201 Lakeview Blvd. Fremont, California 94538
Re: K232802
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: September 8, 2023 Received: September 12, 2023
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" (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).
1
Your device is also subject to, among other requirements, the Quality System (OS) 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 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
2
Indications for Use
510(k) Number (if known) K232802
Device Name TMINI™ Miniature Robotic System
Indications for Use (Describe)
TMINI™ Miniature Robotic System is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon by providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components.
The robotic device placement is performed relative to anatomical landmarks as recorded using the system intraoperatively and based on a surgical plan determined preoperatively using CT based surgical planning tools.
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 TMINIM Miniature Robotic System is to be used with the following knee replacement systems in accordance with the indications and contraindications:
- · Enovis™ EMPOWR Knee System®
- · Ortho Development® BKS® and BKS TriMax® Knee System
- · Total Joint Orthopedics Klassic® Knee System
- · United® U2™ Knee Total Knee System
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 triangle replacing 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 triangle adds a touch of color and visual interest.
510(k) SUMMARY K232802
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: | 08 September 2023 |
Device Information:
| Device Classification: | Class II |
|---|---|
| Trade Name: | TMINITM Miniature Robotic System |
| Common name: | Orthopedic Stereotaxic Instrument |
| Classification name: | Stereotaxic Instrument |
| Regulation number: | 882.4560 |
| Product Code: | OLO |
Predicate Device:
The TMINI™ Miniature Robotic System (Additional Knee Systems) 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 K230202.
Device Modification:
The purpose of this submission is to add three additional FDA cleared knee implant systems that are compatible with the TMINI™ Miniature Robotic System to the Enovis™ EMPOWR Knee System® that is already cleared for use with the device. The three new implant systems are: the Ortho Development® BKS® and BKS TriMax® Knee System, the Total Joint Orthopedics Klassic® Knee System, and the United® U2™ Knee System. 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 three additional knee implant systems.
Device Description:
Like its predicate, 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
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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" represented by a blue, elongated triangle pointing downwards. Below the word "THINK" is the word "SURGICAL" in a smaller, sans-serif font. A registered trademark symbol is located to the right of the letter K.
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 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 quide 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:
Like the predicate, 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:
The only difference between the indications for use of the current device and the predicate is the addition of the three additional knee systems. See Table-1 below.
| Product | TMINI™ Miniature Robotic
System (Additional Knee
Systems) | TMINI™ Miniature Robotic
System | Conclusion |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| 510(k) number | Subject Device | K230202 | |
| Manufacturer | THINK Surgical, Inc | THINK Surgical, Inc | |
| Product Code | OLO | OLO | SAME |
| Regulation | 21 CFR 882.4560 | 21 CFR 882.4560 | SAME |
| Intended Use | Intended to assist the surgeon
in providing software defined
spatial boundaries for
orientation and reference
information to anatomical
structures during orthopedic
procedures. | Intended to assist the surgeon
in providing software defined
spatial boundaries for
orientation and reference
information to anatomical
structures during orthopedic
procedures. | SAME |
| Indications for Use | 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 | 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 | Substantially
Equivalent
(Adds
Compatibility with
three additional
total knee implant
systems) |
| Product | TMINI™ Miniature Robotic
System (Additional Knee
Systems) | TMINI™ Miniature Robotic
System | Conclusion |
| | software-defined spatial
boundaries for orientation and
reference information to
identifiable anatomical
structures for the accurate
placement of knee implant
components. | 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 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. | 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 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 | 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® | |
Table 1: Comparison of Intended Use and Indications for Use
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TMINI™ Miniature Robotic System Special 510(k) Submission
Substantial Equivalence:
Both the TMINI™ Miniature Robotic System (Additional Knee Systems), 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
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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 three additional knee implant systems. None of these changes either individually or in the aggregate alter the intended use, indications for use (other than the addition of the three new implant systems), design, materials, technology, or operational principles of the TMINI™ Miniature Robotic System.
The Indications for Use of the new device and its predicate are identical except for the addition of the three new implant systems to the list of compatible implant systems.
Performance testing to verify the cutting accuracy of the subject device was conducted following similar test methods and acceptance criteria to those used for the predicate device. This testing demonstrated that the TMINI™ Miniature Robotic System met all test criteria and specifications. Validation testing, with methods and acceptance criteria similar to that used for the predicate device, was conducted using simulated surgical testing in a cadaver model and all test criteria were met.
Biocompatibility information for patient contacting materials and testing for the TMINI™ Miniature Robotic System were presented in predicate device submission K230202. There are no material changes to any of the direct patient contact components of the TMINI Miniature Robotic System.
All four of the Guide Blocks for the TMINI™ Miniature Robotic System (Additional Knee Systems) have text printed on the Indirect Patient Contact Surface of the blocks using Pad printing ink. Biocompatibility testing was provided to assess these materials and included: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity and Pyrogenicity. All 5 tests passed the acceptance criteria of the test protocol.
Substantial equivalence in technological characteristic and performance of the TMINI™ Miniature Robotic System to the predicate device is outlined in Table-2 below:
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Image /page/7/Picture/0 description: The image shows the logo for Think Surgical. The logo is composed of the word "THINK" in a bold, sans-serif font, with the "I" replaced by a blue, elongated triangle pointing downwards. Below the word "THINK" is the word "SURGICAL" in a smaller, sans-serif font.
| Product | TMINI™ Miniature Robotic
System (Additional Knee
Systems) | TMINI™ Miniature Robotic
System | Substantial
Equivalence
Conclusion |
|--------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|
| 510(k) number | Subject Device | K230202 | |
| 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 |
| -Intraoperative
planning changes | Implant position can be
adjusted along bone axis only,
preserving the intended implant
positioning philosophy. | Implant position can be
adjusted along bone axis only,
preserving the intended implant
positioning philosophy. | 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 |
| Product | TMINI™ Miniature Robotic System (Additional Knee Systems) | TMINI™ Miniature Robotic System | Substantial Equivalence Conclusion |
| 510(k) number | Subject Device | K230202 | |
| Manufacturer | THINK Surgical Inc. | THINK Surgical Inc. | |
| -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® U2™ Knee System | - Enovis ™ EMPOWR Knee System® | Substantially Equivalent
(addition of three new
implant
systems) |
| Performance
Testing
-Cutting Accuracy
Verification | Passed | Passed | SAME |
| -Cadaver Lab
Validation Testing | 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-2: Substantial Equivalence
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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 Systems) is substantially equivalent to the predicate, TMINI™ Miniature Robotic System (K230202), 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 TMINI™ Miniature Robotic System (Additional Knee Systems) is equivalent to that of the predicate device. The
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TMINI™ Miniature Robotic System (Additional Knee Systems) is as safe and effective as the predicate device and does not raise any new questions of safety and effectiveness; therefore, a determination of Substantial Equivalence is supported.