{"filing":{"accession_number":"0001193125-26-233429","cik":"0000884624","ticker":"OFIX","company_name":"Orthofix Medical Inc.","form":"8-K","filing_date":"2026-05-21","report_date":null,"primary_document":"ofix-20260521.htm","primary_document_url":"https://www.sec.gov/Archives/edgar/data/884624/000119312526233429/ofix-20260521.htm"},"events":[{"id":9380,"run_id":8225,"accession_number":"0001193125-26-233429","anchor_item_number":"7.01","event_type":"other_material","event_domain":"catchall","is_material":true,"confidence":0.75,"summary":"The FDA reclassified non-invasive bone growth stimulators from Class III to Class II, triggering CMS reimbursement changes that reduce Medicare reimbursement by approximately 10% for HCPCS codes E0747, E0748, and E0760. This regulatory action materially impacts Orthofix's financial outlook, forcing the company to lower full-year 2026 net sales guidance to $838–$848 million and adjusted EBITDA to $90–$93 million, and to withdraw its three-year financial targets. While this is a material event affecting investor assessment, it does not fit neatly into the more specific categories (it is neither a restatement, impairment, covenant breach, nor litigation), making \"other_material\" the most appropriate classification.","company_name":"Orthofix Medical Inc.","ticker":"OFIX","filing_date":"2026-05-21","form":"8-K","submitted_at":null,"items":[{"id":999,"accession_number":"0001193125-26-233429","item_number":"7.01","item_title":"Regulation FD Disclosure.","event_type":"other_material","event_domain":"catchall","is_material":true,"confidence":0.75,"reasoning":"The FDA reclassified non-invasive bone growth stimulators from Class III to Class II, triggering CMS reimbursement changes that reduce Medicare reimbursement by approximately 10% for HCPCS codes E0747, E0748, and E0760. This regulatory action materially impacts Orthofix's financial outlook, forcing the company to lower full-year 2026 net sales guidance to $838–$848 million and adjusted EBITDA to $90–$93 million, and to withdraw its three-year financial targets. While this is a material event affecting investor assessment, it does not fit neatly into the more specific categories (it is neither a restatement, impairment, covenant breach, nor litigation), making \"other_material\" the most appropriate classification.","classifier_version":"claude-haiku-4-5-20251001+prompt-9e0ffca5","taxonomy_version":"v1","classified_at":"2026-05-22T02:36:26.215085+00:00","company_name":"","ticker":null,"filing_date":""}]}],"classifications":[{"id":999,"accession_number":"0001193125-26-233429","item_number":"7.01","item_title":"Regulation FD Disclosure.","event_type":"other_material","event_domain":"catchall","is_material":true,"confidence":0.75,"reasoning":"The FDA reclassified non-invasive bone growth stimulators from Class III to Class II, triggering CMS reimbursement changes that reduce Medicare reimbursement by approximately 10% for HCPCS codes E0747, E0748, and E0760. This regulatory action materially impacts Orthofix's financial outlook, forcing the company to lower full-year 2026 net sales guidance to $838–$848 million and adjusted EBITDA to $90–$93 million, and to withdraw its three-year financial targets. While this is a material event affecting investor assessment, it does not fit neatly into the more specific categories (it is neither a restatement, impairment, covenant breach, nor litigation), making \"other_material\" the most appropriate classification.","classifier_version":"claude-haiku-4-5-20251001+prompt-9e0ffca5","taxonomy_version":"v1","classified_at":"2026-05-22T02:36:26.215085+00:00","company_name":"Orthofix Medical Inc.","ticker":"OFIX","filing_date":"2026-05-21"}]}