Cleared Traditional

K914453 - UNIVERSAL TIBIAL NAIL AND UNREAMED TIBI...

K914453 is the FDA 510(k) clearance for UNIVERSAL TIBIAL NAIL AND UNREAMED TIBI... by Synthes (Usa). It is a Class 2 Orthopedic device (product code JDS) cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K914453 · Synthes (Usa) · Orthopedic device
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Optimized for regulatory review, auditing and printing
Feb 1992
Decision
137d
Days
Class 2
Risk

K914453 is an FDA 510(k) clearance for the UNIVERSAL TIBIAL NAIL AND UNREAMED TIBIAL NAIL. Classified as Nail, Fixation, Bone (product code JDS), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on February 18, 1992 after a review of 137 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 Synthes (Usa) devices

Submission Details

510(k) Number K914453 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1991
Decision Date February 18, 1992
Days to Decision 137 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 122d · This submission: 137d
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 37
Devices cleared under the same product code (JDS) and FDA review panel - the closest regulatory comparables to K914453.
HAIG NAIL
K940736 · Howmedica Corp. · Sep 1994
SEIDEL HUMERAL LOCKING NAIL -- ADDITIONAL LENGTHS
K924004 · Howmedica Corp. · Nov 1992
UNIVERSAL FEMORAL NAIL
K914371 · Synthes (Usa) · Feb 1992
HUMERAL LOCKING NAIL SYSTEM
K883882 · Howmedica Corp. · Jan 1989
INTRAMEDULLARY BONE PLUG
K832328 · Kirschner Medical Corp. · Oct 1983
FUSON BONE PLUG, RADIOPAQUE
K800142 · Zimmer, Inc. · Feb 1980