Cleared Traditional

K925544 - SEIDEL HUMERAL LOCKING NAIL & ADDITIONA...

K925544 is the FDA 510(k) clearance for SEIDEL HUMERAL LOCKING NAIL & ADDITIONA... by Howmedica Corp.. It is a Class 2 Orthopedic device (product code HSB) cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K925544 · Howmedica Corp. · Orthopedic device
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Mar 1993
Decision
135d
Days
Class 2
Risk

K925544 is an FDA 510(k) clearance for the SEIDEL HUMERAL LOCKING NAIL & ADDITIONAL LENGTHS. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on March 4, 1993 after a review of 135 days - within the typical 510(k) review window.

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: 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 Howmedica Corp. devices

Submission Details

510(k) Number K925544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1992
Decision Date March 04, 1993
Days to Decision 135 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
13d slower than avg
Panel avg: 122d · This submission: 135d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 322
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K925544.
ACUMED RADIUS ROD
K933361 · Acu Med, Inc. · Feb 1994
SEIDEL HUMERAL LOCKING NAIL
K931256 · Howmedica Corp. · Jul 1993
ALTA CFX ROD SYSTEM
K926232 · Howmedica Corp. · Jun 1993
SYNTHES TI-6AI-7NB UNREAMED FEMORAL NAIL
K923580 · Synthes (Usa) · Jan 1993
SYNTHES TITANIUM UNREAMED FEMORAL NAIL
K923597 · Synthes (Usa) · Jan 1993
ALTA FEMORAL INTRAMEDULLARY ROD SYSTEM, ADD SIZES
K922266 · Howmedica Corp. · Sep 1992