Cleared Traditional

K220906 - SECURE-LOCK

K220906 is an FDA 510(k) clearance for SECURE-LOCK, manufactured by Xiros, Ltd.. The device is a Class 2 Orthopedic device with product code HTY cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K220906 · Xiros, Ltd. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2022
Decision
115d
Days
Class 2
Risk

K220906 is an FDA 510(k) clearance for the SECURE-LOCK. Classified as Pin, Fixation, Smooth (product code HTY), Class II - Special Controls.

Submitted by Xiros, Ltd. (Leeds, GB). The FDA issued a Cleared decision on July 22, 2022 after a review of 115 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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 - K220906

510(k) Number K220906 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2022
Decision Date July 22, 2022
Days to Decision 115 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
7d faster than avg
Panel avg: 122d · This submission: 115d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HTY Device Classification - Class 2, Special Controls

Product Code HTY Pin, Fixation, Smooth
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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.

Regulatory Peers - HTY Pin, Fixation, Smooth

All 107
Devices cleared under the same product code (HTY) and FDA review panel - the closest regulatory comparables to K220906.
Electro-Spec Steri-Caps
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K221283 · 4Web Medical, Inc. · Sep 2022
Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires
K213982 · Pacific Instruments · Feb 2022
restor3d Pin Implants
K211789 · Restor3d · Jan 2022
Small Bone Nailing System
K211439 · Skeletal Dynamics, Inc. · Sep 2021