Blog

- ORTHOPEDICS

Hyalex Orthopaedics Announces FDA 510(k) Clearance of the HYALEX Slalom™ MTP Hemiarthroplasty System

LEXINGTON, Mass., April 21, 2026 (GLOBE NEWSWIRE) — Hyalex Orthopaedics today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its HYALEX Slalom™ MTP Hemiarthroplasty Implant, a next-generation implant designed around the proprietary Hydrosurf™ materials platform, for the treatment of degenerative conditions affecting the first metatarsophalangeal (MTP) joint, including hallux rigidus.

Read More »

MedCAD’s AccuStride® Receives FDA 510(k) Clearance for New Anatomical Lower Leg Region Tib/Fib Solution

DALLAS, April 8, 2026 /PRNewswire/ — Dallas-based MedCAD has received FDA 510(k) clearance of its AccuStride® lower leg tibia and fibula system, making these patient-specific precision devices available to surgeons. The unique design of the custom-made planning and surgical guides will enable orthopedic surgeons to correct multiple related pathologies and osteotomies in a single procedure.

Read More »