Cleared Traditional

K832328 - INTRAMEDULLARY BONE PLUG

K832328 is an FDA 510(k) clearance for INTRAMEDULLARY BONE PLUG, manufactured by Kirschner Medical Corp.. The device is a Class 2 Orthopedic device with product code JDS cleared through the Traditional 510(k) pathway after a 97-day FDA review.

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

FDA 510(k) Submission Details - K832328

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
Combination Product No
PCCP Authorized No
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.

JDS Device Classification - Class 2, Special Controls

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 38
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
SILASTIC BONE PLUG H.P.(CEMENT RESTRICT)
K800898 · Dow Corning Corp. Healthcare Industries Materials · May 1980
FUSON BONE PLUG, RADIOPAQUE
K800142 · Zimmer, Inc. · Feb 1980
FEMORAL CEMENT RESTRICTOR
K800144 · Biomet, Inc. · Feb 1980