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This month we learn about products from two lesser-known companies, Teslake and Precision AI, and see the latest from more familiar faces, SurGenTec and Neo Medical.
Spine
Teslake | Spinal System (Thoracolumbosacral Pedicle Screw), K240963
Submitted April 2024, granted June 2024
Primary predicate: Eisertech Spinal System, K142576
FYI: The Spinal System comprises a variety of polyaxial screws, fixed-angle screws, rods, hooks, locking nuts and transverse connectors. The purpose of this clearance is to add additional implants and navigated instruments to the Teslake Spinal System.
This is the company’s first FDA 510(k). Development initiatives include a spine-manipulating robot called “The Teslake Robotic System” and Guardinium Alloy, a biocompatible metal that eradicates microbes on contact.
The robotic system is described as “the first robot that can manipulate the human spine with precise force and sub-millimeter positional accuracy.”
Guardinium Alloy is described as having the ability to disrupt the cell walls of microbes, leading to the rapid elimination of microbes on its surface. The alloy has mechanical strength similar to stainless steel.
Orthobiologics
SurGenTec | ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit), K240664
Submitted March 2024, granted August 2024
Primary predicate: Ranfac Bone Marrow Aspiration Needle,K131157
FYI: The kit employs a centrifuge-free method to collect high-quality aspirate with minimal contaminants. Its integrated diamond-tip trocar works simultaneously with CELLect filtration technology, which reduces bone spicules and other impurities, resulting in refined aspirate with enhanced cell viability.
By maximizing marrow contact with a surface area up to three times greater than conventional methods, the BMAN Kit enhances the retrieval of progenitor cells while reducing contamination with peripheral blood and bone spicules.
Robotic/Digital
Neo Medical | ADVISE Software, K230195
Submitted January 2023, granted March 2024
Primary predicate: NuVasive Bendini, K122742
FYI: ADVISE is an AI-driven augmented reality intraoperative data platform, part of the Neo Universal portfolio of advanced surgical technologies. The name is an acronym for Advanced Dynamic Visualization of Intraoperative Spinal Equilibrium. It supports the ability to design a spinal rod in real time.
Proceeds from Neo Medical’s recent raise of funds will be used in part to enhance the capabilities of ADVISE.
Precision AI | Surgical Planning System, K233992
Submitted December 2023, granted August 2024
Primary predicate: Materialise Shoulder System, K212569
FYI: The clearance addresses a preoperative planner for simulation of surgical interventions for shoulder replacement surgery. The software is used to assist in the positioning of shoulder components by creating a 3D bone construct of the joint and allowing the surgeon to visualize, measure, reconstruct, annotate and edit pre-surgical plan data.
The system is indicated for total and reverse shoulder procedures using the following Enovis implant systems: AltiVate Anatomic Shoulder, AltiVate Anatomic Augmented Glenoid, Turon Shoulder and the Reverse Shoulder Prosthesis.
