Cleared Traditional

K242237 - Jewel Soft Tissue Reinforcement Device (102-6005) (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K242237 is an FDA 510(k) clearance for the Jewel Soft Tissue Reinforcement Device (102-6005). Classified as Mesh, Surgical, Non-resorbable, Orthopedics, Reinforcement Of Ligament (product code QUW), Class II - Special Controls.

Submitted by Xiros Limited (Yeadon, GB). The FDA issued a Cleared decision on July 15, 2025 after a review of 350 days - an unusually long review period, suggesting complex equivalence evaluation.

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

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Submission Details

510(k) Number K242237 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
228d slower than avg
Panel avg: 122d · This submission: 350d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.