True/Flex Humerus Cap

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

510(k) Number

K920598 ↗

FDA Product Code

HSB

Device Class

Class II

Regulation

21 CFR Part 888.3020

Advisory Committee

Orthopedic

FDA Decision

SESE Substantially Equivalent

• Texas Scottish Rite Easy/Lock Fixator

  Class II

  FDA 510(k) K931578 Active Cleared 22 Feb 1994

• True/ Flex Fibula Rods

  Class II

  FDA 510(k) K924656 Active Cleared 24 Nov 1992

• True/Flex Metatarsal Rods

  Class II

  FDA 510(k) K924657 Active Cleared 24 Nov 1992

• True/Flex Humerus, Ulna & Radius Intramed Rods Sys

  Class II

  FDA 510(k) K913949 Active Cleared 17 Jan 1992

• Femrod and Femrod Recon Insert

  Class II

  FDA 510(k) K935383 Active Cleared 21 Mar 1995

• Femoral Intramedullary Rods

  Class II

  FDA 510(k) K926465 Active Cleared 25 Aug 1993

See all devices from Applied Osteo Systems, Inc. →

• What is the True/Flex Humerus Cap used for?

  The True/Flex Humerus Cap is a humeral component designed for use in shoulder arthroplasty procedures, serving as part of a prosthetic joint replacement system to restore shoulder function.

• Is the True/Flex Humerus Cap sterile when supplied, and can it be reused?

  The device is supplied non-sterile and is intended for reusable use after appropriate cleaning and sterilization by the user, meaning it must be processed according to validated reprocessing instructions before each surgical use.

• How is the True/Flex Humerus Cap identified and differentiated in sizes or models?

  The device is available in various sizes as indicated by the model designation, with size distinctions critical for proper anatomical fit during shoulder arthroplasty implantation.

• What regulatory pathway was used for the True/Flex Humerus Cap, and what is its product code?

  The True/Flex Humerus Cap received FDA 510(k) clearance under K920598 and is classified under product code HSB, indicating its substantial equivalence to a legally marketed predicate device.