Cleared Traditional

K974289 - EPI-UNION PLATING SYSTEM

K974289 is an FDA 510(k) clearance for EPI-UNION PLATING SYSTEM, manufactured by Howmedica, Inc.. The device is a Class 2 Orthopedic device with 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

FDA 510(k) Submission Details - K974289

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.

HRS Device Classification - Class 2, Special Controls

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 1279
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K974289.
DEPUY MOTECH PEAK 3MM FIXATION ROD SYSTEM
K980368 · Depuy, Inc. · Apr 1998
SYNTHES STERILE 2.7 MM RECONSTRUCTION PLATES
K974908 · Synthes (Usa) · Mar 1998
PLAQUAGRAFE, AGRAFE P4V
K974603 · Atlas Technology · Mar 1998
LACTOSORB PANELS
K974309 · Biomet, Inc. · Jan 1998
CARPAL ENGAGING WRIST FUSION PLATE
K974030 · Terray Corp. · Jan 1998
TIMESH SYSTEM
K974017 · Sofamor Danek USA,Inc. · Jan 1998