4 stories this morning, for surgeons and the people who support them.
- FDA issues draft guidance on premarket submissions for robotically-assisted surgical devices; orthopedic (OLO) and neurological (HAW) stereotaxic systems are explicitly out of scope; comments due November 24, 2026 — FDA draft guidance 'Robotically-Assisted Surgical Devices - Premarket Submissions' (50 pages, docket FDA-2026-N-9505), released September 24 and noticed in the Federal Register September 25, 2026 (https://www.federalregister.gov/documents/2026/09/25/2026-19704/robotically-assisted-surgical-devices-premarket-submissions-draft-guidance-for-industry-and-food-and); also AHA News September 25 and MedTech Dive (https://www.medtechdive.com/news/fda-issues-draft-guidance-for-surgical-robots/831509/). Scope: teleoperated, software-controlled leader/follower systems with operator console and bedside arms for open, minimally invasive or endoluminal procedures. Scope section (draft PDF https://www.fda.gov/media/194987/download, lines 59-78) states pre-operative planning and stereotaxic systems are not RASDs and are outside scope, naming orthopedic stereotaxic instruments (product code OLO), neurological (HAW) and ENT (PGW) under 21 CFR 882.4560; also excludes remotely teleoperated RASDs and autonomous robots, and interventional-catheter RASDs. Covers stability/latency, motion control, visualization, software, wireless, cybersecurity, reprocessing/sterilization, biocompatibility, human factors, training, labeling; in vivo section says clinical data may be requested for new RASDs or when user-interface/robotic changes raise questions non-clinical models can't answer. Comments due November 24, 2026. MedTech Dive reports a two-day FDA public workshop December 2-3 on autonomous and remote teleoperation, and quotes Evercore ISI: 'a specific pathway for FDA approval, compared with a prior framework that had some ambiguity.' Not previously covered (grep of drafts for draft guidance/RASD: none). Source
- Avesi Partners invests in New Age Medical, a St. Louis spine supply hub linking 85+ manufacturers, 100+ reps, 200+ hospitals/ASCs and 350+ surgeons, to fund expansion, new specialties and M&A — PR Newswire, Stamford CT, September 28, 2026; also ORTHOWORLD (https://www.orthoworld.com/new-age-medical-gains-investment-for-expansion/), PE Hub and Ortho Spine News. New Age Medical, founded 2012 by CEO Kevin Bly, St. Louis, supplies spinal implants and orthobiologics, working with 85+ OEMs, 100+ sales reps, 200+ hospitals/ASCs and 350+ surgeons. Investment to support national expansion, entry into new specialties and M&A-driven growth. Terms not disclosed. Avesi Partners (Stamford CT / Richmond VA) has over $2.2B AUM and targets platform companies with about $5-30M EBITDA. Not previously covered. Source
- SI-BONE receives FDA 510(k) clearance for iFuse Granite Onyx, aimed at screw loosening at the UIV and LIV of spinal fusion constructs in low-density bone — Company release, September 28, 2026; also Investing.com (https://www.investing.com/news/company-news/sibone-receives-fda-clearance-for-spinal-fusion-system-93CH-4921100). First SI-BONE product for compromised bone outside the pelvis; addresses loosening at upper and lower instrumented vertebrae, which the company says occurs in up to 27% of fusion constructs, in patients with low bone density. 3D-printed bone integration platform with bone-density-specific surface and anatomy-specific thread form. SI-BONE's third FDA breakthrough-designated platform. No clinical data or launch timing disclosed; company plans to leverage existing Granite surgeon relationships. Quotes from Han Jo Kim (HSS) and Gregory Mundis (Scripps). Earlier SI-BONE coverage was the iFuse TORQ recall (Sept 14/25) and Granite as context for Xenix's Riva Anchor clearance (Sept 23); Onyx is a new product and not previously covered. Source
- HSS cohort at EBJIS-MSIS 2026: extended oral antibiotics after two-stage TKA reimplantation did not reduce PJI-related reoperation in 2,181 patients — Healio, September 28, 2026, reporting Kim BI, Sama AJ, et al. (Hospital for Special Surgery), presented at the joint EBJIS-MSIS Conference, September 17-19, 2026, Porto. Retrospective cohort of 2,181 two-stage TKA reimplantations for PJI; 473 received extended oral antibiotics (>=60 cumulative days within 90 days, supplied within 2 weeks of second stage) vs 1,708. PJI-related reoperation: 90 days 5.5% vs 4.1%, 1 year 7.8% vs 8.3%, 2 years 10.6% vs 10.8%, none significant. ED visits, readmissions and 30-day adverse events (7.4% vs 7.0%) similar. No relevant disclosures. Context: Frank JM, Della Valle CJ, et al., CORR 2017;475(1):56-61 (PMID 27387759), multicenter RCT interim analysis: 3 months oral antibiotics, failure from infection 5% (3/59) vs 19% (9/48), p=0.016, mean follow-up 14 vs 10 months. The Sept 28 episode covered a different EBJIS-MSIS abstract (UPMC CLEAR rapid exchange). Source
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