Aequalis Ascend Flex Shoulder System

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K190521 ↗

FDA Product Code

KWS

Device Class

Class II

Regulation

21 CFR Part 888.3660

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• BLUEPRINT Patient Specific Instrumentation

  Class II

  FDA 510(k) K160555 Active Cleared 10 Jun 2016

• Aequalis(Tm) Ascent(Tm) Flex Shoulder System

  Class II

  FDA 510(k) K140082 Active Cleared 18 Jul 2014

• 611 Ankle Fusion Nail

  Class II

  FDA 510(k) K130051 Active Cleared 15 Jul 2013

• Aequalis Shoulder Fracture System, Aequalis Reversed Shoulder Prosthesis, Aequalis Reversed Fracture Shoulder Prothesis

  Class II

  FDA 510(k) K131231 Active Cleared 16 Oct 2013

• Blueprint Mixed Reality system Open recall

  Class II

  FDA 510(k) K222510 Active Cleared 20 Jan 2023

• BLUEPRINT™ Patient Specific Instrumentation

  Class II

  FDA 510(k) K232265 Active Cleared 21 Feb 2024

See all devices from Tornier S.A.S. →

• What is the Aequalis Ascend Flex Shoulder System used for?

  The Aequalis Ascend Flex Shoulder System is designed to achieve accurate and efficient restoration of natural shoulder biomechanics across a wide range of patients by addressing variables such as humeral inclination, stem orientation within the humerus, and head positioning on the resected surface during orthopedic surgical procedures.

• How is the Aequalis Ascend Flex Shoulder System supplied and is it reusable?

  The system is supplied as a sterile, single-use device intended for orthopedic surgical procedures, meaning it is designed for one-time use only and should not be reprocessed or reused to maintain sterility and patient safety.

• What regulatory authorization does the Aequalis Ascend Flex Shoulder System have?

  The Aequalis Ascend Flex Shoulder System is authorized under FDA 510(k) clearance with the specific clearance number K190521, indicating it was found substantially equivalent to a legally marketed predicate device.