Cleared Traditional

K100238 - HFN 125 DEGREE 9-13 MM

K100238 is an FDA 510(k) clearance for HFN 125 DEGREE 9-13 MM, manufactured by DePuy Orthopaedics, Inc.. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K100238 · DePuy Orthopaedics, Inc. · Orthopedic device
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May 2010
Decision
104d
Days
Class 2
Risk

K100238 is an FDA 510(k) clearance for the HFN 125 DEGREE 9-13 MM, 180MM, HFN 130 DEGREE 9-13 MM, HFN RH 125 DEGREE 9-13MM. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by DePuy Orthopaedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on May 11, 2010 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - 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 DePuy Orthopaedics, Inc. devices

FDA 510(k) Submission Details - K100238

510(k) Number K100238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2010
Decision Date May 11, 2010
Days to Decision 104 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
18d faster than avg
Panel avg: 122d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HSB Device Classification - Class 2, Special Controls

Product Code HSB Rod, Fixation, Intramedullary And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3020
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 - HSB Rod, Fixation, Intramedullary And Accessories

All 365
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K100238.
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K091566 · Zimmer GmbH · Oct 2009
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K092646 · Synthes (Usa) · Sep 2009