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We rounded up recent FDA 510(k) clearances that provide solutions for shoulder replacement, spine fusion surgeries and fixation of ulna fractures. The clearances also include a first-of-its kind single-use arthroscope and a new navigation system that optimizes the placement of knee implants.
Joint Replacement
Catalyst OrthoScience | Catalyst EA (Ellipsoid Anatomic) Convertible Stemmed Shoulder, K222317
Submitted August 2022, granted November 2022
Primary predicate: Encore Medical (DJO) AltiVate Reverse Shoulder, K172351
FYI: This is reportedly the market’s first stemmed shoulder replacement system to feature an ellipsoid humeral head, which is designed to allow for more accurate restoration of natural joint kinematics compared to spherical head designs. Limited U.S. release is slated for 2Q23, followed by a larger commercial launch later in 2023.
Spine
Astura Medical El Capitan X
Astura Medical | El Capitan X Expandable Anterior Lumbar Interbody Fusion (ALIF) System, K222554
Submitted August 2022, granted January 2023
FYI: Provides a complete range of expandable anatomic spacers and fixation options, with infinitely adjustable expansions in height and lordosis up to 30° for a patient-specific solution. This is the company’s first expandable technology platform with multiple fixation configurations to receive FDA 510(k) clearance. Astura Medical is also scheduled to release El Capitan Oblique ALIF in the spring and has plans to introduce several new, expandable technologies in the coming months.
Trauma
Conventus-Flower Orthopedics Flex Thread Ulna IM Nail
Conventus Flower Orthopedics | Flex-Thread Ulna Intramedullary (IM) Nail, K222390
Submitted August 2022, granted November 2022
Primary predicate: Conventus Flower Orthopedics Flex-Thread Distal Fibula IM Nail, K202858
FYI: The device marks a new application and portfolio expansion of the company’s Flex-Thread technology platform. Intended for use in the fixation of fractures and osteotomies of the ulna, this is reportedly the market’s first and only flexible, threaded ulna IM nail. The design allows the nail to flex as it is inserted into the intramedullary canal, providing ease of insertion and point-contact fixation. The product launched in February 2023, and will be available in a wide range of diameters and lengths.
Sports Medicine
Pristine Surgical | Summit Arthroscopic Visualization System, K223244
Submitted October 2022, granted December 2022
FYI: Summit is a first-of-its-kind 4K single-use arthroscope designed to improve the efficiency, consistency and safety of arthroscopic procedures. The arthroscope is packed sterile, easy to set up and indicated for use in hip, knee and shoulder surgeries. It connects to the company’s Pristine Connect cloud-based software to constantly provide ultra-high-definition images without ever becoming obsolete. Pristine Surgical developed Summit to address challenges with conventional reusable arthroscopes, which can be complex to use, expensive to purchase and costly to maintain. Summit will launch in 1Q23 with a transparent subscription-based pricing model and an automated re-ordering system.
Robotics/Tech
Naviswiss Knee
Naviswiss | Naviswiss Knee, K223351
Submitted November 2022, granted January 2023
FYI: The Naviswiss Knee solution is a landmark-based navigation application that assists surgeons in the optimal positioning and alignment of knee replacement implants. Surgeons can choose to work with the platform’s express workflow setting that features navigated flexion/extension and varus/valgus alignment or its advanced workflow setting that provides additional navigation of medial and lateral resection height and range of motion overviews.
Naviswiss is planning a limited market release in the United States with established surgical partners. The full launch of the system is planned for the second half of 2023.
