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510(k) K191598

AOS ES Retrograde Femoral Nail by Advanced Orthopaedic Solutions, Inc. — Product Code HSB

K191598 is an FDA 510(k) premarket notification submitted by Advanced Orthopaedic Solutions, Inc. for the device "AOS ES Retrograde Femoral Nail". The FDA issued a decision of Substantially Equivalent on July 18, 2019. The device falls under product code HSB (Rod, Fixation, Intramedullary And Accessories), a Class II device regulated under 21 CFR 888.3020. Advanced Orthopaedic Solutions, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 2019
Date Received
June 17, 2019
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Rod, Fixation, Intramedullary And Accessories
Device Class
Class II
Regulation Number
888.3020
Review Panel
OR
Submission Type

Other clearances by Advanced Orthopaedic Solutions, Inc.

  • K202489 — AOS Fibonacci Lower Extremity Plating System – AOS Proximal Tibia Plating System (October 26, 2020)
  • K202099 — AOS Galileo™ Trochanteric Nail System (August 28, 2020)
  • K182466 — AOS Calcaneal Plating System (October 30, 2018)
  • K160409 — AOS Anterolateral Proximal Humeral Plate (March 15, 2016)
  • K143204 — AOS Clavicle Intramedullary Device (June 3, 2015)
  • K141912 — AOS SMALL BONE EXTERNAL FIXATION, THREADED HALF PINS, AOS SMALL BONE EXTERNAL FI (October 29, 2014)
  • K141228 — AOS 6.5MM CAPTURED, FULLY THREADED CANCELLOUS SCREW (July 8, 2014)
  • K133081 — TROCHANTERIC NAILS AND ES TROCHANTERIC NAILS, HUMERAL NAISL, TIBIAL NAILS, ANTEG (December 31, 2013)
  • K132005 — RETROGRADE FEMORAL NAIL (September 10, 2013)
  • K123569 — ANTEGRADE FEMORAL NAIL (May 24, 2013)

Other clearances for product code HSB

  • K261481 — Pangea Femur Reconstruction System (June 29, 2026)
  • K253080 — AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA0 (June 18, 2026)
  • K261651 — Precice™ Max System and Precice™ Ankle Salvage System (June 18, 2026)
  • K253155 — Fule Metallic Lockable Intramedullary Nail Systems (June 17, 2026)
  • K253046 — HERA Interlocking Intramedullary Nailing System (June 16, 2026)
  • K260146 — FITBONE® TRANSPORT AND LENGTHENING SYSTEM (May 19, 2026)
  • K253991 — Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA (May 8, 2026)
  • K261043 — AUTOBAHN™ Nailing System (April 24, 2026)
  • K252016 — Arthrex Humeral Nails (March 20, 2026)
  • K252961 — Fusion FibFix Nail (March 18, 2026)

FDA data resources