Copy to clipboard 
In this month’s recap, I’m pleased to share some first orthopedic clearances from companies that may be new to your radar. Amber Implants has a solution for treating vertebral compression fractures, Biodynamik intros a device for fracture fixation and bone transport of the tibia and TheraMicro offers a way to reinforce soft tissue during tendon and ligament repair surgery.
Spine
Amber Implants | VCFix Spinal System, K250637
Submitted March 2025, granted May 2025
Primary predicate: Stryker SpineJack System, K223294
FYI: VCFix is designed for the treatment of vertebral compression fractures via vertebral body augmentation. The system is intended for use with an approved bone cement and to be placed, using a transpedicular approach, in a fractured vertebra with or without posterior fixation.
The device was granted Breakthrough Device Designation by FDA in 2021. At one-year follow-up in 2025 for all patients enrolled in its first-in-human clinical trial, no device-related adverse events were reported and significant improvements in key clinical performance outcomes were observed, regardless of cement augmentation. Patients, both with and without cement, experienced immediate and sustained reductions in pain levels.
Founded in 2018 and based in Holland, Amber Implants has raised €8.8 million (US $10 million) in Series A funding. Leadership brings experience from roles at Dymicron, medical magnesium, Medtronic Spine & Biologics, Spinal Kinetics, Stryker Orthopaedics and Vexim.
Trauma
Biodynamik | XT3 System, K241357
Submitted May 2024, granted January 2025
Primary predicate: Orthofix ModulSystem, K955848
FYI: The product is indicated for fracture fixation and bone transport of the tibia in adults and comprises fixator, half pins and instrumentation. XT3 functions similarly to other unilateral external fixation systems, where the frame is affixed and secured onto previously positioned external fixation pins within the bone.
Biodynamik states its mission is to provide solutions that help prevent unnecessary amputations and restore mobility for patients with complex limb conditions. Founded in 2024, the company is based in California and its leadership brings years of experience from roles at Ellipse Technologies, NuVasive Specialized Orthopedics, Exactech and Ortho Development.
Sports Medicine
TheraMicro | TekBrace Solo Soft Tissue Reinforcement Device, K251063
Submitted April 2025, granted May 2025
Primary predicate: Xiros Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device, K222978
FYI: The product is offered in a central tubular weave tape that tapers down to cords at both ends, and the implant is available in two sizes. Pockets provide access to the inside of the tubular section.
The non-absorbable polyethylene terephthalate-based device is intended for reinforcement of soft tissues that are repaired by suture or other fixation devices during tendon and ligament repair surgery. Applications include reinforcement of the rotator cuff, patellar, Achilles, biceps, quadriceps tendon, medial collateral ligament, lateral collateral ligament, spring ligament, deltoid ligament, ulnar collateral ligament or other tendons or extra-articular ligaments.
Established in 2024 and based in Tennessee, TheraMicro has attracted talent with former roles from a range of companies like BioComposites, CONMED, In2Bones, Medtronic Spinal & Biologics, OsteoMed, Smith+Nephew and Wright Medical.
