Cleared Traditional

K222978 - Poly-Tape/Infinity-Lock Soft Tissue Rei...

K222978 is an FDA 510(k) clearance for Poly-Tape/Infinity-Lock Soft Tissue Rei..., manufactured by Xiros, Ltd.. The device is a Class 2 Orthopedic device with product code QUW cleared through the Traditional 510(k) pathway after a 90-day FDA review.

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

K222978 is an FDA 510(k) clearance for the Poly-Tape/Infinity-Lock Soft Tissue Reinforcement Device. Classified as Mesh, Surgical, Non-resorbable, Orthopedics, Reinforcement Of Ligament (product code QUW), Class II - Special Controls.

Submitted by Xiros, Ltd. (Leeds, GB). The FDA issued a Cleared decision on December 27, 2022 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 878.3300 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Xiros, Ltd. devices

FDA 510(k) Submission Details - K222978

510(k) Number K222978 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QUW Device Classification - Class 2, Special Controls

Product Code QUW Mesh, Surgical, Non-resorbable, Orthopedics, Reinforcement Of Ligament
Device Class Class 2 - 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.