Cleared Traditional

K854338 - KIRSCHNER INTRAMEDULLARY NAIL SYSTEM

K854338 is an FDA 510(k) clearance for KIRSCHNER INTRAMEDULLARY NAIL SYSTEM, manufactured by Kirschner Medical Corp.. The device is a Class 2 Orthopedic device with product code HSB cleared through the Traditional 510(k) pathway after a 42-day FDA review.

K854338 · Kirschner Medical Corp. · Orthopedic device
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Dec 1985
Decision
42d
Days
Class 2
Risk

K854338 is an FDA 510(k) clearance for the KIRSCHNER INTRAMEDULLARY NAIL SYSTEM. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Kirschner Medical Corp. (Timonium, US). The FDA issued a Cleared decision on December 9, 1985 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - 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: 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 - K854338

510(k) Number K854338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1985
Decision Date December 09, 1985
Days to Decision 42 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
80d faster than avg
Panel avg: 122d · This submission: 42d
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 338
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K854338.
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
MEC INTRAMEDULLARY ROD
K850441 · Pfizer, Inc. · Apr 1985
ACE INTRAMEDULLARY ROD FOR SMALL BONES
K850142 · Buckman Co., Inc. · Feb 1985
GROSSE AND KEMPF LOCKING NAIL SYS.
K813371 · Howmedica Corp. · Mar 1982