The orthopedic device pipeline showed steady activity to start 2026, as seven systems cleared the FDA the first few months, including new shoulder arthroplasty tools, a hip replacement implant and an ACL fixation system.
Here are seven orthopedic systems, devices and implants that have received FDA clearance, as reported by Becker’s since Jan. 14:
Note: This list is not exhaustive.
- Hyalex Orthopaedics earned FDA 510(k) clearance for its Slalom MTP hemiarthroplasty implant.
- The University of Utah’s Spencer Fox Eccles School of Medicine received FDA 510(k) clearance for the CoAptix S 7.5-millimeter system, a bone screw platform designed for fracture fixation and joint stabilization.
- Zimmer Biomet secured FDA 510(k) clearance for an extension to its Identity Shoulder System and Comprehensive Reverse Shoulder Systems.
- Catalyst OrthoSciences received FDA 510(k) clearance for its Archer Patient-Specific Instrumentation shoulder arthroplasty technology.
- Zimmer Biomet’s G7 TM Acetabular System, an implant for primary and revision hip replacement surgeries, received FDA 510(k) clearance.
- Abanza received FDA 510(k) clearance for QuadLock, a fixation system for ACL reconstruction.
- Miach Orthopaedics received 510(k) clearance from the FDA to update labeling of its BEAR knee implant.
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