Cleared Traditional

KIRSCHNER COMPRESSION HIP SCREW SYSTEM (K854205) - FDA 510(k) Clearance

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

K854205 · Kirschner Medical Corp. · Orthopedic device
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Nov 1985
Decision
34d
Days
Class 2
Risk

K854205 is an FDA 510(k) clearance for the KIRSCHNER COMPRESSION HIP SCREW SYSTEM. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Kirschner Medical Corp. (Timonium, US). The FDA issued a Cleared decision on November 19, 1985 after a review of 34 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Kirschner Medical Corp. devices

Submission Details

510(k) Number K854205 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1985
Decision Date November 19, 1985
Days to Decision 34 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 122d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 175
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K854205.
MODIFIED TROCHANTER CABLE GRIP SYSTEM
K872224 · Howmedica Corp. · Aug 1987
MODIFIED OMEGA COMPRESSION HIP SCREW SYSTEM
K872223 · Howmedica Corp. · Jun 1987
DEPUY COMPRESSION HIP SCREW SYSTEM
K861178 · Depuy, Inc. · Apr 1986
TROCHANTER CABLE GRIP SYSTEM
K844068 · Howmedica Corp. · Jun 1985
CORSTREN COMPRESSION TUBE & PLATE
K830196 · Zimmer, Inc. · Mar 1983
COMPRESSION HIP SCREW SIDE-PLATE
K823548 · Howmedica Corp. · Dec 1982