Cleared Traditional

K974289 - EPI-UNION PLATING SYSTEM

K974289 is the FDA 510(k) clearance for EPI-UNION PLATING SYSTEM by Howmedica, Inc.. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K974289 · Howmedica, Inc. · Orthopedic device
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Feb 1998
Decision
90d
Days
Class 2
Risk

K974289 is an FDA 510(k) clearance for the EPI-UNION PLATING 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, Inc. (Rutherford, US). The FDA issued a Cleared decision on February 12, 1998 after a review of 90 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, Inc. devices

Submission Details

510(k) Number K974289 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received November 14, 1997
Decision Date February 12, 1998
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
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 946
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K974289.
ROGACHEFSKY DISTAL RADIUS PLATES
K981283 · Howmedica, Inc. · Jun 1998
DEPUY MOTECH PEAK 3MM FIXATION ROD SYSTEM
K980368 · Depuy, Inc. · Apr 1998
SYNTHES STERILE 2.7 MM RECONSTRUCTION PLATES
K974908 · Synthes (Usa) · Mar 1998
LACTOSORB PANELS
K974309 · Biomet, Inc. · Jan 1998
TIMESH SYSTEM
K974017 · Sofamor Danek USA,Inc. · Jan 1998
ORBITAL RECONSTRUCTION PLATES
K973982 · Howmedica, Inc. · Jan 1998