With FDA 510(k) clearance on April 1, 2021, THINK Surgical, Inc. added three more FDA cleared knee implant systems to be used with the company’s TSolution® One Total Knee Application bringing the total to EIGHT knee systems now cleared for use with THINK Surgical’s robotic assist system.
Three More Knee TKAs Get 510(k) for THINK Surgical Robotic
2 min read Premium comments
#fda510kclearance#roboticsurgery#kneereplacementsurgery
The EIGHT compatible knee systems are…
The three new implant systems are:
- Ortho Development Balanced Knee
- Total Joint Orthopedics Klassic Knee
- DJO Surgical® EMPOWR Knee System®
The five previous compatible knee implant systems are:
- Aesculap Columbus Knee System
- Corin Unity Knee
- DJO Surgical EMPOWR 3D Knee
- United U2 Knee
- Zimmer Biomet Persona
The first-generation application received FDA 510(k) clearance in October 2019. The second-generation system received FDA clearance in November 2020.
Indications
The application, according to FDA documents, is intended for use as a “device that uses diagnostic images of the patient acquired specifically to assist the physician with preoperative planning and to provide orientation and reference information during intraoperative procedures.”
The robotic surgical tool, directed by the surgeon, “precisely” implements the presurgical software plan.
The preoperative planning software and robotic surgical tool are used as an alternative to manual planning and resecting techniques for the distal femur and proximal tibia preparation in primary total knee arthroplasty.
The application is indicated for orthopedic procedures, “in which resecting techniques used for the distal femur and proximal tibia may be considered to be safe and effective and where references to rigid anatomical structures may be made.”
The application is also intended to help the surgeon determine reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. The application, state the FDA documents, facilitates accurate positioning of TKA implants, relative to those alignment axes.
Open Implant Library
In a May 10, 2021, press release, the company said its application is the “only commercially available active robot system for total knee replacement that supports an open implant library, giving surgeons a choice of implant options.”
The application consists of TPLAN®, a 3D pre-surgical planning workstation, and TCAT®, the active robot.
The company says these components of the application allow the surgeon to design and prepare, in a virtual environment, the patient’s personalized joint replacement surgical plan, prior to surgery. The active robot “aids the surgeon in executing the preoperative surgical plan with automated, hands-free cutting and removal of the diseased bone and cartilage.”
THINK Surgical is a privately held Fremont, California-based medical device and technology company focusing on developing, manufacturing and marketing active robotics for orthopedic surgery.
React:
Discussion
This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
Join the conversation
Orthopedic professionals are discussing this. Sign in and upgrade to read every comment and add your voice.