FDA Product Code QUW: Mesh, Surgical, Non-resorbable, Orthopedics, Reinforcement Of Ligament
A Non-resorbable Orthopedic Mesh Used For Reinforcement Of Soft Tissue Where Weakness Exists In Ligament Repair.
Leading manufacturers include Xiros, Ltd., Xiros Limited and Theramicro.
4
Total
4
Cleared
130d
Avg days
2022
Since
Growing category -
3 submissions in the last 2 years
vs 1 in the prior period
Review times increasing: avg
144d
recently vs 90d historically
FDA 510(k) Cleared Mesh, Surgical, Non-resorbable, Orthopedics, Reinforcement Of Ligament Devices (Product Code QUW)
4 devices
Cleared
Jul 15, 2025
Jewel Soft Tissue Reinforcement Device (102-6005)
Xiros Limited
Orthopedic
350d
Cleared
May 30, 2025
TekBrace Solo Soft Tissue Reinforcement Device
Theramicro
Orthopedic
56d
Cleared
Dec 27, 2022
Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device
Xiros, Ltd.
Orthopedic
90d
About Product Code QUW - Regulatory Context
510(k) Submission Activity
4 total 510(k) submissions under product code QUW since 2022, with 4 receiving FDA clearance (average review time: 130 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 1 in the prior period - suggesting growing market activity in this device classification.
FDA 510(k) Review Time - QUW Product Code
Recent submissions under QUW have taken an average of 144 days to reach a decision - up from 90 days historically. Manufacturers should account for longer review timelines in current project planning.
QUW devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →