Cleared Traditional

OMEGA TOTAL HIP SYSTEM FOR USE WITHOUT BONE CEMENT (LINE EXTENSION) (K964924) - FDA 510(k) Clearance

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

K964924 · Osteoimplant Technology, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1997
Decision
88d
Days
Class 2
Risk

K964924 is an FDA 510(k) clearance for the OMEGA TOTAL HIP SYSTEM FOR USE WITHOUT BONE CEMENT (LINE EXTENSION). 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 March 7, 1997 after a review of 88 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

Submission Details

510(k) Number K964924 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 1996
Decision Date March 07, 1997
Days to Decision 88 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
34d faster than avg
Panel avg: 122d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 325
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K964924.
TCP-COATED POROCOAT AML FEMORAL HIP PROSTHESIS
K964650 · Depuy, Inc. · Jun 1997
PEGGED ACETABULAR COMPONENT
K970501 · Biomet, Inc. · Apr 1997
HOWMEDICA MODULAR REPLACEMENT SYSTEM-PROXIMAL FEMUR
K965164 · Howmedica Corp. · Mar 1997
VERSYS HIP SYSTEM--FIBER METAL TAPER HIP PROSTHESIS
K964769 · Zimmer, Inc. · Feb 1997
OSTEONICS MODULAR ACETABULAR CUP (MICROSTRUCTURED VERSION)
K963946 · Osteonics Corp. · Jan 1997
APEX HOLE ELIMINATOR PS
K963309 · Depuy, Inc. · Nov 1996