Cleared Traditional

K112481 - FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT (FDA 510(k) Clearance)

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

K112481 · Ascension Orthopedic · Orthopedic device
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Apr 2012
Decision
224d
Days
Class 2
Risk

K112481 is an FDA 510(k) clearance for the FIRST CHOICE DRUJ SYSTEM, PARTIAL HEAD IMPLANT. Classified as Prosthesis, Wrist, Hemi-, Ulnar (product code KXE), Class II - Special Controls.

Submitted by Ascension Orthopedic (Austin, US). The FDA issued a Cleared decision on April 9, 2012 after a review of 224 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3810 - 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 Ascension Orthopedic devices

Submission Details

510(k) Number K112481 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2011
Decision Date April 09, 2012
Days to Decision 224 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
102d slower than avg
Panel avg: 122d · This submission: 224d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KXE Prosthesis, Wrist, Hemi-, Ulnar
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3810
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.