Cleared Traditional

K220260 - Hercules Syndesmosis Implant System

K220260 is the FDA 510(k) clearance for Hercules Syndesmosis Implant System by In2bones USA, LLC. It is a Class 2 Orthopedic device (product code HTN) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K220260 · In2bones USA, LLC · Orthopedic device
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Mar 2022
Decision
59d
Days
Class 2
Risk

K220260 is an FDA 510(k) clearance for the Hercules Syndesmosis Implant System. Classified as Washer, Bolt Nut (product code HTN), Class II - Special Controls.

Submitted by In2bones USA, LLC (Memphis, US). The FDA issued a Cleared decision on March 31, 2022 after a review of 59 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 In2bones USA, LLC devices

Submission Details

510(k) Number K220260 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2022
Decision Date March 31, 2022
Days to Decision 59 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
63d faster than avg
Panel avg: 122d · This submission: 59d
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 65
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