Cleared Traditional

INTRAMEDULLARY BONE PLUG (K832328) - FDA 510(k) Clearance

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

K832328 · Kirschner Medical Corp. · Orthopedic device
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Oct 1983
Decision
97d
Days
Class 2
Risk

K832328 is an FDA 510(k) clearance for the INTRAMEDULLARY BONE PLUG. Classified as Nail, Fixation, Bone (product code JDS), Class II - Special Controls.

Submitted by Kirschner Medical Corp. (Mchenry, US). The FDA issued a Cleared decision on October 20, 1983 after a review of 97 days - within the typical 510(k) review window.

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: 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 Kirschner Medical Corp. devices

Submission Details

510(k) Number K832328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1983
Decision Date October 20, 1983
Days to Decision 97 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 122d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDS Nail, 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 - JDS Nail, Fixation, Bone

All 35
Devices cleared under the same product code (JDS) and FDA review panel - the closest regulatory comparables to K832328.
UNIVERSAL FEMORAL NAIL
K914371 · Synthes (Usa) · Feb 1992
UNIVERSAL TIBIAL NAIL AND UNREAMED TIBIAL NAIL
K914453 · Synthes (Usa) · Feb 1992
HUMERAL LOCKING NAIL SYSTEM
K883882 · Howmedica Corp. · Jan 1989
FUSON BONE PLUG, RADIOPAQUE
K800142 · Zimmer, Inc. · Feb 1980
FEMORAL CEMENT RESTRICTOR
K800144 · Biomet, Inc. · Feb 1980
B.G. FLEXIBLE NAIL SYSTEM
K770130 · Howmedica Corp. · Jan 1977