FDA Product Code OSN: Software For Diagnosis/treatment
Software Associated With An Orthopedic Trauma Device Which Is Intended For The Diagnosis Or Treatment Of Traumatic Or Reconstructive Orthopedic Conditions
Leading manufacturers include Arrowhead Medical Device Technologies, LLC, Smith & Nephew, Inc. and Disior, Ltd..
4
Total
4
Cleared
125d
Avg days
2014
Since
Stable submission activity - 1 submissions in the last 2 years
Review times improving: avg
93d
recently vs 135d historically
FDA 510(k) Cleared Software For Diagnosis/treatment Devices (Product Code OSN)
4 devices
Cleared
Feb 26, 2026
ENOS Software Guided External Fixation System
Disior, Ltd.
Orthopedic
93d
Cleared
Aug 25, 2022
Acute QC Strut and Components
Smith & Nephew, Inc.
Orthopedic
65d
Cleared
Aug 13, 2018
Deformity Analysis and Correction Software (DACS) and Instrumentation
Arrowhead Medical Device Technologies, LLC
Orthopedic
166d
About Product Code OSN - Regulatory Context
510(k) Submission Activity
4 total 510(k) submissions under product code OSN since 2014, with 4 receiving FDA clearance (average review time: 125 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA 510(k) Review Time - OSN Product Code
Recent submissions under OSN have taken an average of 93 days to reach a decision - down from 135 days historically, suggesting improved FDA processing for this classification.
OSN devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →