Cleared Traditional

OMEGA II MODULAR TOTAL HIP SYSTEM (K984227) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K984227 · Osteoimplant Technology, Inc. · Orthopedic device
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Apr 1999
Decision
134d
Days
Class 2
Risk

K984227 is an FDA 510(k) clearance for the OMEGA II MODULAR TOTAL HIP SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Osteoimplant Technology, Inc. (Hunt Valley, US). The FDA issued a Cleared decision on April 8, 1999 after a review of 134 days - within the typical 510(k) review window.

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. 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 Osteoimplant Technology, Inc. devices

Submission Details

510(k) Number K984227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1998
Decision Date April 08, 1999
Days to Decision 134 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
12d slower than avg
Panel avg: 122d · This submission: 134d
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 280
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K984227.
COLOR BUFFED CEMENTED FEMORAL
K992903 · Biomet, Inc. · Sep 1999
BI-METRIC CCOCR HEAD/NECK REPLACEMENT SYSTEM
K992058 · Biomet, Inc. · Jul 1999
COLOR BUFFED ANSWER CEMENTED FEMORAL
K991987 · Biomet, Inc. · Jun 1999
SYNERGY CEMENTED HIP STEM
K990369 · Smith & Nephew, Inc. · Mar 1999
MODULAR PROTUSIO CUP
K990032 · Biomet, Inc. · Feb 1999
APF POROUS COATED LINE EXTENSION
K984154 · Biomet, Inc. · Feb 1999