4 stories this morning, for surgeons and the people who support them.
- Orthofix Q3 2026: net sales $207.9M (+1.1% reported; pro forma ex-M6 $207.8M, +2.2%); Global Spine Fixation +1%, Spinal Implants, Biologics and Enabling Technologies $107.4M (-1.1%), Therapeutic Solutions $64.0M (+4.5%), Global Limb Reconstruction $36.4M (+8.5%); adjusted EBITDA $26.0M (12.5%); FY26 pro forma net sales cut to $825-830M from $845-855M and adjusted EBITDA to $86-88M from $95-98M on Q3 performance and accelerated U.S. Spine actions (instrument set supply and allocation, focus on highest-performing distributor partners and products) — Orthofix reported third-quarter results on November 9 and cut full-year sales and adjusted EBITDA guidance, citing third-quarter performance and the anticipated fourth-quarter impact of accelerated U.S. Spine commercial actions. Source
- Treace Medical Q3 2026: revenue $48.3M (-4%) despite double-digit case volume growth, on mix shift to lower-priced MIS bunion systems and lower bunion kit volume; ex-stocking-distributor revenue up mid-single digits; ~45% of Lapiplasty surgeons using one or more of the three systems launched in Q3 2025 (from 40% in Q2); FY26 revenue narrowed to $206-210M (-1% to -3%), adjusted EBITDA loss improved to $1-2M; Tailorplasty full launch 1Q27 per ORTHOWORLD — Treace reported a 4% revenue decline on November 6 as its own lower-priced minimally invasive bunion systems took share from Lapiplasty kits, while narrowing guidance and improving its profitability outlook. Source
- FDA posts a discussion paper on benefit-risk for robotic medical devices with autonomous or remote teleoperation capabilities (docket FDA-2026-N-13135, comments due January 5, 2027) and schedules a hybrid public workshop December 2-3, 2026 at White Oak; Zimmer Biomet introduced a 'Surgeon-Guided Autonomy' framework at AAHKS the same day — FDA asked for public input on terminology, benefit-risk and risk mitigation for autonomous and remotely teleoperated robotic devices, in a paper that is not draft guidance; MedTech Dive reports no such device had U.S. marketing authorization as of July. Source
- Eur Spine J, NORDSTEN Spinal Stenosis Trial secondary analysis: of 125 patients with redundant nerve roots on preoperative MRI, 58 (46%) still had them 2 years after decompression; persistence tracked with less decompression and more residual stenosis, but ODI change was -23.0 vs -22.5 (p=0.86) with no between-group differences in ZCQ or leg and back pain — In a Norwegian multicenter trial cohort, redundant nerve roots that persisted on two-year MRI after decompression for lumbar stenosis signalled less radiologic decompression but not worse clinical outcomes. Source
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