Cleared Traditional

K984227 - OMEGA II MODULAR TOTAL HIP SYSTEM

K984227 is an FDA 510(k) clearance for OMEGA II MODULAR TOTAL HIP SYSTEM, manufactured by Osteoimplant Technology, Inc.. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K984227 · Osteoimplant Technology, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K984227

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
Combination Product No
PCCP Authorized No
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.

JDI Device Classification - Class 2, Special Controls

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 483
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K984227.
COLOR BUFFED ANSWER CEMENTED FEMORAL
K991987 · Biomet, Inc. · Jun 1999
8MM FORGED CEMENTED STEM
K991227 · Encore Orthopedics, Inc. · Jun 1999
PROVIDENCE CUP SYSTEM
K990821 · Biopro, Inc. · Apr 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