FDA Recap: Newer Companies with 510(k) Clearances
Meet three companies with solutions for sacroiliac joint fusion, foot/ankle repair and pre-surgical planning for shoulder replacement. ...
Apr 23 2025,
Products
Native Orthopaedics Gains 510(k) for Dragonfly Knotless Technology
Dragonfly is a knotless finger trap technology that provides instant retensioning capabilities for knee repair procedures....
Apr 02 2025,
restor3d Earns 510(k) for iTotal Identity CR 3DP Porous Total Knee
This is the first cementless addition to the Identity knee platform, and preserves the benefits of a patient-specific implant....
Apr 01 2025,
FDA Recap: Looking at Sports Med and Trauma Clearances
Learn more about four recently 510(k)-cleared products from ABANZA, Arcuro Medical, Orthofix and OrthoNovis....
Mar 25 2025,
BioPoly Granted US Patent for Shoulder Implant
The BioPoly Hill-Sachs Implant is designed to stabilize the shoulder joint in patients experiencing chronic dislocations....
Mar 12 2025,
Pixee Medical Launching Knee+ NexSight in the US
Knee+ NexSight allows real-time navigation without setups or intraoperative instrument calibration, allowing surgeons to focus on the patient....
Mar 11 2025,
FDA Allows Compassionate Use for Reverse Hip System
FDA granted approval of Hip Innovation Technology's Reverse HRS for Compassionate Use in a patient with spinal fusion. ...
Mar 07 2025,
FDA Recap: Enabling Tech for Improved Surgical Planning and Performance
This month, we’re keeping to a theme of products cleared to assist in the repair of shoulder, hip and knee...
Feb 25 2025,
Maxx Orthopedics Gains 510(k) for Porous Titanium Tibial Baseplate
With the introduction of the 3D-printed baseplate, the Freedom Total Knee System now offers a cementless tibiofemoral solution....
Feb 19 2025,
First-Ever Elbow Surgery with BioPoly Radial Head Implant
The implant features a smooth titanium stem designed for natural positioning, reducing joint stress....
Feb 13 2025,
Study Demonstrates Reproducibility with Exactech Knee Balancing
Combined with ExactechGPS, Newton Knee technology offers dynamic soft tissue analytics, pre-resection operative insights and full-range personalized planning....
Feb 11 2025,
TriMed Unveils New Upper Extremity Products
Wrist Fixation System 3 includes volar plating, fragment specific implants, a bridge plate and TriMed’s “Magic Screwdriver” tool....
Feb 06 2025,
Gyder Surgical Gains FDA 510(k) for GYDER Hip System
GYDER is a pin-less and image-less system for accurate positioning of the acetabular cup during anterior hip arthroplasty....
Feb 04 2025,
Bioretec Granted CE Mark for RemeOs Trauma Screw
Indications include use for fracture and malalignment fixation in upper and lower extremities, excluding the hand and forefoot....
Feb 03 2025,
FDA Recap: Clearances in Shoulder Replacement Solutions
Shoulders carry the weight. These companies help keep them working with recently-cleared systems, including Stryker’s awaited Mako Shoulder robotic application....
Jan 29 2025,