Cleared Traditional

K990003 - J-SERIES OMEGA TOTAL HIP SYSTEM

K990003 is an FDA 510(k) clearance for J-SERIES OMEGA TOTAL HIP SYSTEM, manufactured by Osteoimplant Technology, Inc.. The device is a Class 2 Orthopedic device with product code LPH cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K990003 · Osteoimplant Technology, Inc. · Orthopedic device
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Feb 1999
Decision
51d
Days
Class 2
Risk

K990003 is an FDA 510(k) clearance for the J-SERIES OMEGA TOTAL HIP SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Osteoimplant Technology, Inc. (Hunt Valley, US). The FDA issued a Cleared decision on February 24, 1999 after a review of 51 days - a notably fast clearance 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: 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 - K990003

510(k) Number K990003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1999
Decision Date February 24, 1999
Days to Decision 51 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
71d faster than avg
Panel avg: 122d · This submission: 51d
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 K990003.
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