Cleared Traditional

Jewel Soft Tissue Reinforcement Device (102-6005)

K242237 · Xiros Limited · Orthopedic
Jul 2025
Decision
350d
Days
Class 2
Risk

About This 510(k) Submission

K242237 is an FDA 510(k) clearance for the Jewel Soft Tissue Reinforcement Device (102-6005), a Mesh, Surgical, Non-resorbable, Orthopedics, Reinforcement Of Ligament (Class II — Special Controls, product code QUW), submitted by Xiros Limited (Yeadon, GB). The FDA issued a Cleared decision on July 15, 2025, 350 days after receiving the submission on July 30, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number K242237 FDA.gov
FDA Decision Cleared SESE
Date Received July 30, 2024
Decision Date July 15, 2025
Days to Decision 350 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code QUW — Mesh, Surgical, Non-resorbable, Orthopedics, Reinforcement Of Ligament
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.3300
Definition A Non-resorbable Orthopedic Mesh Used For Reinforcement Of Soft Tissue Where Weakness Exists In Ligament Repair.