Cleared Traditional

K000817 - OMEGA II MODULAR TOTAL HIP SYSTEM

K000817 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 87-day FDA review.

K000817 · Osteoimplant Technology, Inc. · Orthopedic device
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Jun 2000
Decision
87d
Days
Class 2
Risk

K000817 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 June 8, 2000 after a review of 87 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Osteoimplant Technology, Inc. devices

FDA 510(k) Submission Details - K000817

510(k) Number K000817 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2000
Decision Date June 08, 2000
Days to Decision 87 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
35d faster than avg
Panel avg: 122d · This submission: 87d
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 K000817.
TORNIER CEMENT RESTRICTOR
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K001733 · Zimmer, Inc. · Jun 2000
ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL L-SERIES CEMENTED
K001335 · Exactech, Inc. · May 2000
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K990330 · Implex Corp. · Mar 2000
PAR 5 ACETABULAR COMPONENT
K000254 · Biomet, Inc. · Feb 2000