Cleared Traditional

K854227 - FASCILULATED NAIL

K854227 is an FDA 510(k) clearance for FASCILULATED NAIL, manufactured by The Deca Co.. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K854227 · The Deca Co. · Orthopedic device
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Feb 1986
Decision
109d
Days
Class 2
Risk

K854227 is an FDA 510(k) clearance for the FASCILULATED NAIL. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by The Deca Co. (Costa Mesa, US). The FDA issued a Cleared decision on February 4, 1986 after a review of 109 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - 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 The Deca Co. devices

FDA 510(k) Submission Details - K854227

510(k) Number K854227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1985
Decision Date February 04, 1986
Days to Decision 109 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
13d faster than avg
Panel avg: 122d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HSB Device Classification - Class 2, Special Controls

Product Code HSB Rod, Fixation, Intramedullary And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3020
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 - HSB Rod, Fixation, Intramedullary And Accessories

All 486
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K854227.
GROSSE AND KEMPF LOCKING NAIL SYSTEM, NON-SLOT ROD
K860756 · Howmedica Corp. · Mar 1986
ACE IM ROD
K860592 · Buckman Co., Inc. · Mar 1986
FEMOROTIBIAL MEDULLARY NAIL
K853250 · Zimmer, Inc. · Feb 1986
KIRSCHNER INTRAMEDULLARY NAIL SYSTEM
K854338 · Kirschner Medical Corp. · Dec 1985
INTERLOCKING FEMORAL NAIL(LEFT & RIGHT) TIBIAL NAI
K852020 · Warsaw Orthopedic, Inc. · May 1985
MEC INTRAMEDULLARY ROD
K850441 · Pfizer, Inc. · Apr 1985