QUW

Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament

Product code
QUW
Device name
Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament
Device class
Class 2
21 CFR
21 CFR 878.3300
Medical specialty
General, Plastic Surgery
Marketing pathway
510(K)
Flag
Implant
510(k) clearances (last 3 years)
5

FDA classification definition

a non-resorbable orthopedic mesh used for reinforcement of soft tissue where weakness exists in ligament repair.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (4)

Last three years. Most recent: 2026-08-18.

NumberDecision dateApplicantDevice nameSummary
K2627292026-08-18TheramicroTeKBrace Solo Soft Tissue Reinforcement DevicePDF
K2616212026-06-09TheramicroTekBrace Solo Soft Tissue Reinforcement DevicePDF
K2422372025-07-15Xiros LimitedJewel Soft Tissue Reinforcement Device (102-6005)PDF
K2510632025-05-30TheramicroTekBrace Solo Soft Tissue Reinforcement DevicePDF

4 summaries are archived here for direct download.

Official FDA classification page: QUW
Classification and pathway per current FDA publications. Data from openFDA (CC0).