Cleared Traditional

Infinity-Lock Button System (K180243) - FDA 510(k) Clearance

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

K180243 · Xiros, Ltd. · Orthopedic device
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Apr 2018
Decision
64d
Days
Class 2
Risk

K180243 is an FDA 510(k) clearance for the Infinity-Lock Button System. Classified as Washer, Bolt Nut (product code HTN), Class II - Special Controls.

Submitted by Xiros, Ltd. (Leeds, GB). The FDA issued a Cleared decision on April 3, 2018 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Xiros, Ltd. devices

Submission Details

510(k) Number K180243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 2018
Decision Date April 03, 2018
Days to Decision 64 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
58d faster than avg
Panel avg: 122d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HTN Washer, Bolt Nut
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - HTN Washer, Bolt Nut

All 53
Devices cleared under the same product code (HTN) and FDA review panel - the closest regulatory comparables to K180243.
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GRAVITY™ Syndesmosis LP
K170249 · Wrightmedicaltechnologyinc · Jun 2017
INVISIKNOT Ankle Syndesmosis Repair Kit
K162996 · Smith & Nephew, Inc. · Jun 2017