Cleared Traditional

K242896 - Caliber Intramedullary Fixation System

K242896 is an FDA 510(k) clearance for Caliber Intramedullary Fixation System, manufactured by Nvision Biomedical Technologies. The device is a Class 2 Orthopedic device with product code HWC cleared through the Traditional 510(k) pathway after a 135-day FDA review.

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

FDA 510(k) Submission Details - K242896

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.

HWC Device Classification - Class 2, Special Controls

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 680
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