Cleared Traditional

K854205 - KIRSCHNER COMPRESSION HIP SCREW SYSTEM

K854205 is an FDA 510(k) clearance for KIRSCHNER COMPRESSION HIP SCREW SYSTEM, manufactured by Kirschner Medical Corp.. The device is a Class 2 Orthopedic device with product code KTT cleared through the Traditional 510(k) pathway after a 34-day FDA review.

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

FDA 510(k) Submission Details - K854205

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
Combination Product No
PCCP Authorized No
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.

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 298
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K854205.
RICHARDS EXTERNAL FIXATION SYSTEM
K870961 · Richards Medical Co., Inc. · Mar 1987
SCREW DRIVER/BONE SCREW WRENCH/TAP & GUIDE PIN
K862311 · Warsaw Orthopedic, Inc. · Jul 1986
DEPUY COMPRESSION HIP SCREW SYSTEM
K861178 · Depuy, Inc. · Apr 1986
MEC DISTAL FEMORAL BOLT
K850403 · Pfizer, Inc. · Jul 1985
MEC HIP BOLT
K850413 · Pfizer, Inc. · Jul 1985
MEC ROD CONNECTOR
K850443 · Pfizer, Inc. · Jul 1985