Adaptable Ortho Innovations Intramedullary Nail System— 510(k) K210285

Name: FDA 510(k) clearance K210285
Creator: U.S. Food and Drug Administration
Published: 2021-03-18

Substantially Equivalent

Adaptable Ortho Innovations, LLC

FDA 510(k) clearance K210285 for Adaptable Ortho Innovations Intramedullary Nail System, Substantially Equivalent on 2021-03-18. Applicant: Adaptable Ortho Innovations, LLC. Device class: 2.

Clearance details

Applicant: Adaptable Ortho Innovations, LLC
Product code: Product code HSB
Device class: Class 2
Regulation: 21 CFR 888.3020
Advisory panel: Orthopedic
Date received: 2021-02-02
Decision date: 2021-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Potsdam, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HSB

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K261189 — Freedom Nail Ankle Fusion System2026-10-19
K261345 — Pediatric Nailing Platform Femur2026-09-24
K261481 — Pangea Femur Reconstruction System2026-06-29
K253080 — AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)2026-06-18
K261651 — Precice Max System and Precice Ankle Salvage System2026-06-18

Adverse events under product code HSB

product code HSB

Death: 49
Injury: 12,083
Malfunction: 6,561
Other: 1
Total: 18,694

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.