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Rub shoulders. Shoulder the weight. Shoulder to cry on. Shoulder to the wheel. These joints do a lot. Orthopedic companies help keep them working with these recently-cleared systems, including Stryker’s long awaited Mako Shoulder robotic application, FH Ortho’s reverse shoulder solution and stemless implants from Smith+Nephew and Zimmer Biomet.
FH ORTHO | JARVIS Glenoid Reverse Shoulder Prosthesis, K242253
Submitted July 2024, granted November 2024
Primary predicate: FH Industrie Arrow Reverse Shoulder, K171789
FYI: System comprises three components: glenophere (cobalt chromium molybdenum alloy), baseplate and fixation (screw or post; latter two titanium alloy). All components are provided sterile via gamma irradiation.
The subject device is an expansion of FH Ortho’s shoulder portfolio, designed to provide surgeons with options when a reverse shoulder prosthesis is needed.
The key features of JARVIS include availability in 10°, 20° and 30° angles, providing increased flexibility for surgeons; central screw and long peg options, in addition to the four compression or locking peripheral screws, to ensure the stability of the baseplate; and three different lateralization rates and several eccentric versions for distalization. A central Morse taper ensures the glenosphere’s fixation to the baseplate.
JARVIS is compatible with the company’s Arrow Prime and Short Stem systems for the humeral side.
Smith+Nephew | AETOS Shoulder System Stemless Humeral Prosthesis, K240716
Submitted March 2024, granted November 2024
Primary predicate: Smith+Nephew AETOS Shoulder, K220847
FYI: Addresses the demand for anatomic total shoulder replacement with a small O.R. footprint. It is designed to maximize metaphyseal fixation and stability with an inlay collar, cruciate fins and porous titanium coating to encourage biological fixation.
Stryker | Mako Shoulder Application (1.0), K242373
Submitted August 2024, granted November 2024
Primary predicate: MAKO Surgical Mako Partial Knee Application, K172301
FYI: Modifications relative to this submission include software (addition of the Mako Shoulder Application for Reverse Shoulder Arthroplasty – Glenoid and use of BLUEPRINT for the preoperative workflow and creation of a treatment plan) and hardware (end effector tracking to replace base array for robotic arm tracking, a Mako Shoulder instrument tray and new shoulder-specific instrumentation).
The shoulder application is compatible with the Aequalis PerFORM and PerFORM + Reversed Glenoid. Stryker will first target reverse shoulders, followed by anatomic shoulders.
Mako is the second robotic shoulder application cleared after Zimmer Biomet’s ROSA, which is cleared for reverse and anatomic shoulders.
Mako is now cleared for total and unicompartmental knees, hips, spine and shoulders.
Zimmer Biomet | OsseoFit Stemless Shoulder, K241873
Submitted June 2024, granted December 2024
Primary predicate: Zimmer Sidus Stem-Free Shoulder, K171858
FYI: Designed to match the natural humeral anatomy to optimize anatomical fit while maximizing preservation of healthy bone. OsseoFit Stemless integrates with Identity Humeral Heads with Versa-Dial Technology for infinite offset placement, as well as the Alliance Glenoid for a range of glenoid options to adapt to a patient’s anatomy.
The anatomically designed left- or right-sided anchor implants feature fins that create a press-fit during insertion and contain fully porous windows. Fin geometry and anchor spacing of the implant determine proper orientation and fit into the natural bone and help avoid cortical impingement while reaching dense bone areas.
The design includes anterior reattachment suture holes on the anchor to facilitate subscapularis repair. The system is available in a singular instrument tray to maximize workflow, making it well-suited for ASCs.
