Cleared Traditional

HUCKSTEP INTRAMEDULLARY NAIL (K811017) - FDA 510(k) Clearance

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

K811017 · Downs Surgical , Ltd. · Orthopedic device
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May 1981
Decision
42d
Days
Class 2
Risk

K811017 is an FDA 510(k) clearance for the HUCKSTEP INTRAMEDULLARY NAIL. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Downs Surgical , Ltd. (Walker, US). The FDA issued a Cleared decision on May 27, 1981 after a review of 42 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 Downs Surgical , Ltd. devices

Submission Details

510(k) Number K811017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1981
Decision Date May 27, 1981
Days to Decision 42 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 122d · This submission: 42d
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 K811017.
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
DYNAMIC HIP SCREW
K791619 · Synthes (Usa) · Aug 1979
PEDIATRIC OSTEOTOMY SYSTEM
K790501 · Howmedica Corp. · Apr 1979