POINT Kinguide Robotic-Assisted Surgical System
by Point Robotics MedTech, Inc.
510(k) K220241
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK220241 | Date9 Aug 2022 | StatusActive |
Recalls
No FDA recalls found in the data synced 25 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- OLO
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.4560
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The POINT Kinguide Robotic-Assisted Surgical System is a robotic device designed for surgical assistance, classified under the nomenclature for surgical robots. It integrates robotic guidance to enhance precision and control during orthopedic procedures, supporting minimally invasive techniques for improved clinical outcomes.
This system is supplied as a modular surgical platform, intended for use in clinical settings requiring advanced robotic assistance. It is not specified as single-use or reusable, and no MRI safety classification is provided. The device holds FDA 510(k) clearance under K220241, with a product code of OLO, and was reviewed by the Orthopaedic Devices Panel. No details on sterility or storage conditions are provided in the available data.
Other devices from Point Robotics MedTech, Inc.
Questions
AI-generated answers, 19 Sep 2026
What types of orthopedic procedures can the POINT Kinguide Robotic-Assisted Surgical System assist with, and how does it enhance precision during surgery?
The POINT Kinguide Robotic-Assisted Surgical System is designed to support minimally invasive orthopedic procedures by providing robotic guidance for improved precision and control. While the exact procedures aren’t detailed, its modular surgical platform is intended to assist in complex surgeries where accuracy is critical, such as joint replacements or spinal interventions. The robotic integration helps surgeons achieve better alignment and positioning, reducing human error and potentially improving clinical outcomes.
Is the POINT Kinguide Robotic-Assisted Surgical System intended for single-use or can it be reused in multiple procedures?
The available data does not specify whether the POINT Kinguide Robotic-Assisted Surgical System is single-use or reusable. Since it is described as a modular surgical platform, it may be designed for repeated use in clinical settings, but users should follow manufacturer guidelines for cleaning, maintenance, and reprocessing to ensure safety and functionality. Always confirm with Point Robotics MedTech, Inc. for proper usage instructions.
How is the POINT Kinguide Robotic-Assisted Surgical System regulated, and which advisory committee reviewed its submission?
The POINT Kinguide Robotic-Assisted Surgical System holds FDA 510(k) clearance under the reference number K220241, indicating it was determined to be substantially equivalent to a legally marketed predicate device. The submission was reviewed by the Orthopaedic Devices Panel (OR), which evaluates robotic-assisted surgical devices for orthopedic applications. The decision was made under the traditional 510(k) review pathway.
Are there any specific storage requirements or sterility considerations for the POINT Kinguide Robotic-Assisted Surgical System?
The provided data does not include details about sterility or storage conditions for the POINT Kinguide Robotic-Assisted Surgical System. Since it is a reusable modular platform (assuming based on its design), proper cleaning, sterilization, and storage protocols would be critical to maintain functionality and safety. For accurate guidance, refer to the manufacturer’s instructions or contact Point Robotics MedTech, Inc. directly.
What is the product code assigned to the POINT Kinguide Robotic-Assisted Surgical System, and how does it relate to its regulatory classification?
The POINT Kinguide Robotic-Assisted Surgical System is assigned the product code OLO, which falls under the FDA’s classification for surgical robots. This code reflects its intended use in orthopedic procedures, aligning with the Orthopaedic Devices Panel’s review scope. The code helps regulators and healthcare providers categorize the device within the broader surgical robotics market.