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 Theramicro, Xiros, Ltd. and Xiros Limited.
5
Total
5
Cleared
108d
Avg days
2022
Since
Growing category -
4 submissions in the last 2 years
vs 1 in the prior period
Review times increasing: avg
112d
recently vs 90d historically
FDA 510(k) Cleared Mesh, Surgical, Non-resorbable, Orthopedics, Reinforcement Of Ligament Devices (Product Code QUW)
5 devices
Cleared
Aug 18, 2026
TeKBrace Solo Soft Tissue Reinforcement Device
Theramicro
Orthopedic
18d
Cleared
Jun 09, 2026
TekBrace Solo Soft Tissue Reinforcement Device
Theramicro
Orthopedic
25d
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
5 total 510(k) submissions under product code QUW since 2022, with 5 receiving FDA clearance (average review time: 108 days).
Submission volume has increased in recent years - 4 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 112 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 →