Cleared Traditional

K854445 - KIRSCHNER BONE FIXATION FASTENER SYSTEM

K854445 is an FDA 510(k) clearance for KIRSCHNER BONE FIXATION FASTENER SYSTEM, manufactured by Kirschner Medical Corp.. The device is a Class 2 Orthopedic device with product code JDR cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K854445 · Kirschner Medical Corp. · Orthopedic device
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Nov 1985
Decision
14d
Days
Class 2
Risk

K854445 is an FDA 510(k) clearance for the KIRSCHNER BONE FIXATION FASTENER SYSTEM. Classified as Staple, Fixation, Bone (product code JDR), 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 14 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 - K854445

510(k) Number K854445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 05, 1985
Decision Date November 19, 1985
Days to Decision 14 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
108d faster than avg
Panel avg: 122d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDR Device Classification - Class 2, Special Controls

Product Code JDR Staple, Fixation, Bone
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 - JDR Staple, Fixation, Bone

All 125
Devices cleared under the same product code (JDR) and FDA review panel - the closest regulatory comparables to K854445.
MITEK ANCHOR
K892126 · Mitek Surgical Products, Inc. · Sep 1989
STAPLE FIXATION SYSTEM
K894929 · Concept, Inc. · Aug 1989
ORTHOMET ORTHOPEDIC STAPLES
K874914 · Orthomet, Inc. · Feb 1988
BONE STAPLING FIXATION SYS
K840566 · 3M Company · Nov 1984
STAPLES DESIGNED FOR ARTHROSCOPIC SURG
K830455 · Instrument Makar, Inc. · Mar 1983
ELLISON VITALLIUM FIXATION STAPLE SYS
K822943 · Howmedica Corp. · Oct 1982