Cleared Traditional

K021878 - ESKA MODULAR HIP SYSTEM ACETABULAR COMPONENTS

K021878 is an FDA 510(k) clearance for ESKA MODULAR HIP SYSTEM ACETABULAR COMP..., manufactured by Eska America Corp.. The device is a Class 2 Orthopedic device with product code LPH cleared through the Traditional 510(k) pathway after a 270-day FDA review.

K021878 · Eska America Corp. · Orthopedic device
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Mar 2003
Decision
270d
Days
Class 2
Risk

K021878 is an FDA 510(k) clearance for the ESKA MODULAR HIP SYSTEM ACETABULAR COMPONENTS. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Eska America Corp. (Bradenton, US). The FDA issued a Cleared decision on March 4, 2003 after a review of 270 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - 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 Eska America Corp. devices

FDA 510(k) Submission Details - K021878

510(k) Number K021878 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2002
Decision Date March 04, 2003
Days to Decision 270 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
148d slower than avg
Panel avg: 122d · This submission: 270d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LPH Device Classification - Class 2, Special Controls

Product Code LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3358
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 - LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

All 524
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K021878.
MAYO CONSERVATIVE HIP PROSTHESIS, MODEL 8026 SERIES
K030733 · Zimmer, Inc. · May 2003
MODIFICATION TO DEPUY SOLUTION SYSTEM HIP PROSTHESIS
K030979 · DePuy Orthopaedics, Inc. · Apr 2003
X-SERIES INTEGRAL LATERALIZED HIP COMPONENTS
K030501 · Biomet, Inc. · Mar 2003
U2 ACETABULAR CUP
K022520 · United Orthopedic Corp. · Feb 2003
ACUMATCH P-SERIES POROUS PRESS-FIT FEMORAL COMPONENT
K030236 · Exactech, Inc. · Feb 2003
HA PMI FEMORAL HIP STEM
K030048 · Biomet Orthopedics, Inc. · Feb 2003