Cleared Traditional

K945137 - LUHR TITANIUM ALLOY PAN FIXATION SYSTEM

K945137 is the FDA 510(k) clearance for LUHR TITANIUM ALLOY PAN FIXATION SYSTEM by Howmedica Corp.. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 235-day FDA review.

K945137 · Howmedica Corp. · Orthopedic device
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Jun 1995
Decision
235d
Days
Class 2
Risk

K945137 is an FDA 510(k) clearance for the LUHR TITANIUM ALLOY PAN FIXATION SYSTEM. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Howmedica Corp. (Rutherford, US). The FDA issued a Cleared decision on June 12, 1995 after a review of 235 days - an extended review 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: 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 K945137 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1994
Decision Date June 12, 1995
Days to Decision 235 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
113d slower than avg
Panel avg: 122d · This submission: 235d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HRS Plate, 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 - HRS Plate, Fixation, Bone

All 902
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K945137.
VOLAR DISTAL RADIUS PLATE
K953644 · Synthes (Usa) · Mar 1996
ZIMMER RECONSTRUCTION SYSTEM SYMPHYSEAL BONE PLATE
K953714 · Zimmer, Inc. · Nov 1995
LUHR PAN FIXATION SYSTEM CONDENSED STRAIGHT PLATE, Y PLATES AND 1.5MM BONE SCREW
K951415 · Howmedica Corp. · Jun 1995
LUHR TITANIUM PAN FIXATION SYSTEM
K945139 · Howmedica Corp. · Jun 1995
ORTHOMET ACETABULAR ROOF REINFORCEMENT RING
K944856 · Wrightmedicaltechnologyinc · May 1995
BONE PLATE SYSTEM
K942359 · Acu Med, Inc. · Apr 1995