Cleared Traditional

Caliber Intramedullary Fixation System (K242896) - FDA 510(k) Clearance

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

K242896 · Nvision Biomedical Technologies · Orthopedic device
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Feb 2025
Decision
135d
Days
Class 2
Risk

K242896 is an FDA 510(k) clearance for the Caliber Intramedullary Fixation System. Classified as Screw, Fixation, Bone (product code HWC), Class II - Special Controls.

Submitted by Nvision Biomedical Technologies (San Antonio, US). The FDA issued a Cleared decision on February 5, 2025 after a review of 135 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 Nvision Biomedical Technologies devices

Submission Details

510(k) Number K242896 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2024
Decision Date February 05, 2025
Days to Decision 135 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
13d slower than avg
Panel avg: 122d · This submission: 135d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HWC Screw, Fixation, Bone
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 - HWC Screw, Fixation, Bone

All 404
Devices cleared under the same product code (HWC) and FDA review panel - the closest regulatory comparables to K242896.
TriMed® Compression Screws
K243943 · TriMed, Inc. · Apr 2025
SnapHammer Hammertoe Correction System
K250613 · Nvision Biomedical Technologies, Inc. · Apr 2025
TITANEX Screw Systems
K250304 · Vilex, LLC · Mar 2025
Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw
K242442 · Innovate Orthopaedics, Ltd. · Jan 2025
Arthrex SS VAL and VAL KreuLock™ Compression Screw System
K243195 · Arthrex, Inc. · Jan 2025
Locking Screw,CoCrMo
K242348 · Double Medical Technology, Inc. · Dec 2024