Cleared Traditional

K990330 - CROSS LINKED POLYETHYLENE ACETABULAR CO...

K990330 is the FDA 510(k) clearance for CROSS LINKED POLYETHYLENE ACETABULAR CO... by Implex Corp.. It is a Class 2 Orthopedic device (product code JDI) cleared through the Traditional 510(k) pathway after a 393-day FDA review.

K990330 · Implex Corp. · Orthopedic device
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Mar 2000
Decision
393d
Days
Class 2
Risk

K990330 is an FDA 510(k) clearance for the CROSS LINKED POLYETHYLENE ACETABULAR COMPONENTS,MODEL XX-YY-ZZZZZZ. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Implex Corp. (Allendale, US). The FDA issued a Cleared decision on March 1, 2000 after a review of 393 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3350 - 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. Elevated predicate reliance profile. 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 Implex Corp. devices

Submission Details

510(k) Number K990330 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 1999
Decision Date March 01, 2000
Days to Decision 393 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
271d slower than avg
Panel avg: 122d · This submission: 393d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3350
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 - JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

All 433
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K990330.
SULZER ORTHOPEDICS MS-30 FEMORAL STEM
K001078 · Sulzer Orthopedics, Inc. · Jun 2000
ALLEN MEDULLARY CEMENT PLUGS, ZIMMER POLY PLUG INTRAMEDULLARY SYSTEM, MODEL 8011 SERIES & 1109 & 8109 SERIES
K001733 · Zimmer, Inc. · Jun 2000
ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL L-SERIES CEMENTED
K001335 · Exactech, Inc. · May 2000
PAR 5 ACETABULAR COMPONENT
K000254 · Biomet, Inc. · Feb 2000
MALLORY/HEAD SMOOTH FEMORAL COMPONENT
K994007 · Biomet, Inc. · Feb 2000
THE IMPLEX MODULAR ELLIPTICAL POROUS ACETABULAR CUP, MODEL XX-2YY-ZZZZ
K992409 · Implex Corp. · Oct 1999