Cleared Traditional

K033856 - 5.0 CANNULATED DRILL PIN, 6.0 CANNULATED DRILL-PIN

K033856 is an FDA 510(k) clearance for 5.0 CANNULATED DRILL PIN, manufactured by Peter Stevens, MD. The device is a Class 2 Orthopedic device with product code KTT cleared through the Traditional 510(k) pathway after a 393-day FDA review.

K033856 · Peter Stevens, MD · Orthopedic device
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Jan 2005
Decision
393d
Days
Class 2
Risk

K033856 is an FDA 510(k) clearance for the 5.0 CANNULATED DRILL PIN, 6.0 CANNULATED DRILL-PIN. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Peter Stevens, MD (Salt Lake City, US). The FDA issued a Cleared decision on January 7, 2005 after a review of 393 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. 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 Peter Stevens, MD devices

FDA 510(k) Submission Details - K033856

510(k) Number K033856 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 2003
Decision Date January 07, 2005
Days to Decision 393 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
271d slower than avg
Panel avg: 122d · This submission: 393d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KTT Device Classification - Class 2, Special Controls

Product Code KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
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 - KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

All 335
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K033856.
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K042358 · Wrightmedicaltechnologyinc · Oct 2004