Cleared Traditional

K913355 - LUHR PAN FIXATION SYSTEM

K913355 is the FDA 510(k) clearance for LUHR 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 126-day FDA review.

K913355 · Howmedica Corp. · Orthopedic device
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Dec 1991
Decision
126d
Days
Class 2
Risk

K913355 is an FDA 510(k) clearance for the LUHR 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 December 2, 1991 after a review of 126 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 Howmedica Corp. devices

Submission Details

510(k) Number K913355 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1991
Decision Date December 02, 1991
Days to Decision 126 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
4d slower than avg
Panel avg: 122d · This submission: 126d
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 K913355.
ANSPACH MINI-PLATING SYSTEM
K921338 · The Anspach Effort, Inc. · Feb 1993
DALL MILES BROAD BONE PLATE
K922525 · Howmedica Corp. · Sep 1992
SYNTHES(R) TITANIUM SMALL RECONSTRUCTION PLATE
K915818 · Synthes (Usa) · Jan 1992
SYNTHES MAXILLOFACIAL TITANIUM MICRO SET
K912932 · Synthes (Usa) · Sep 1991
MASTERPIECES(TM)/MICRO/MINI SYSTEMS
K913289 · Storz Instrument Co. · Sep 1991
ALTA CHANNEL PLATE CONNECTOR
K910482 · Howmedica Corp. · Jul 1991