Cleared Traditional

K022520 - U2 ACETABULAR CUP

K022520 is an FDA 510(k) clearance for U2 ACETABULAR CUP, manufactured by United Orthopedic Corp.. The device is a Class 2 Orthopedic device with product code LPH cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K022520 · United Orthopedic Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2003
Decision
210d
Days
Class 2
Risk

K022520 is an FDA 510(k) clearance for the U2 ACETABULAR CUP. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by United Orthopedic Corp. (Hsinchu, TW). The FDA issued a Cleared decision on February 25, 2003 after a review of 210 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 United Orthopedic Corp. devices

FDA 510(k) Submission Details - K022520

510(k) Number K022520 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2002
Decision Date February 25, 2003
Days to Decision 210 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
88d slower than avg
Panel avg: 122d · This submission: 210d
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 476
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K022520.
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K030979 · DePuy Orthopaedics, Inc. · Apr 2003
X-SERIES INTEGRAL LATERALIZED HIP COMPONENTS
K030501 · Biomet, Inc. · Mar 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
VERSYS BEADED FULLCOAT BOWED REVISION HIP PROSTHESIS
K030079 · Zimmer, Inc. · Feb 2003