Cleared Traditional

Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device

K222978 · Xiros, Ltd. · Orthopedic
Dec 2022
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K222978 is an FDA 510(k) clearance for the Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device, a Mesh, Surgical, Non-resorbable, Orthopedics, Reinforcement Of Ligament (Class II — Special Controls, product code QUW), submitted by Xiros, Ltd. (Leeds, GB). The FDA issued a Cleared decision on December 27, 2022, 90 days after receiving the submission on September 28, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 878.3300.

Submission Details

510(k) Number K222978 FDA.gov
FDA Decision Cleared SESE
Date Received September 28, 2022
Decision Date December 27, 2022
Days to Decision 90 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.