Home New England Lexington, MA Hyalex Orthopaedics COMPANY
FDA-cleared device company
1 open job · last seen Oct 23, 2026 · 4 sources
Location: Lexington, MA · source · Oct 15, 2026
Profile checked Oct 10, 2026
Keywords: Hallux Valgus Hallux Limitus Hallux Rigidus Damaged Chondral or Osteochondral Area Cartilage Injury MTP Hemiarthroplasty Hyalex Knee Cartilage System Show all 7 keywords
At a glance HQ Lexington, MA source Region New England Stage FDA-cleared device company Latest trial Not phased (device or behavioral study): The Hyalex MTP Study (Oct 1, 2025) source Timeline Apr 3, 2026 FDA FDA 510(k) clearance: HYALEX® MTP Hemiarthroplasty Implant — K250074, Apr 3, 2026. Applicant at approval: Hyalex Orthopaedics, Inc. source ↗ Oct 1, 2025 Trial start Not phased (device or behavioral study): The Hyalex MTP Study source ↗ Apr 4, 2024 Trial start Not phased (device or behavioral study): The HYALEX Pivotal Study source ↗ Mar 7, 2024 Trial start Not phased (device or behavioral study): The Hyalex First-in-Human Study source ↗ Upcoming milestones May 31, 2027 (ESTIMATED) · Not phased · The Hyalex MTP Study · NCT07538141 May 31, 2027 (ESTIMATED) · Not phased · The Hyalex First-in-Human Study · NCT06344481 2027-12 (ESTIMATED) · Not phased · The HYALEX Pivotal Study · NCT06368700 Estimated primary completion per ClinicalTrials.gov. Dates move.
Clinical trials (lead sponsor) 3 Record Title Phase Status Start Primary completion NCT07538141 The Hyalex MTP Study Not phased (device or behavioral study) Active, not recruiting Oct 1, 2025 May 31, 2027 (estimated) NCT06368700 The HYALEX Pivotal Study Not phased (device or behavioral study) Recruiting Apr 4, 2024 2027-12 (estimated) NCT06344481 The Hyalex First-in-Human Study Not phased (device or behavioral study) Active, not recruiting Mar 7, 2024 May 31, 2027 (estimated)
FDA records (last 2 years) Apr 3, 2026 FDA 510(k) clearance: HYALEX® MTP Hemiarthroplasty Implant — K250074, Apr 3, 2026. Applicant at approval: Hyalex Orthopaedics, Inc. source ↗ Open jobs 1 Title Location (from posting, not HQ) Employer posted First seen Level Laboratory Technician Lexington, MA Oct 13, 2026 Oct 16, 2026 Mid Description
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LinkedIn page linked from the company's own site: source · seen 2026-10-12