Cleared Traditional

K960647 - OMEGA TOTAL HIP SYSTEM FOR CEMENTED APP...

K960647 is an FDA 510(k) clearance for OMEGA TOTAL HIP SYSTEM FOR CEMENTED APP..., 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 215-day FDA review.

K960647 · Osteoimplant Technology, Inc. · Orthopedic device
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Sep 1996
Decision
215d
Days
Class 2
Risk

K960647 is an FDA 510(k) clearance for the OMEGA TOTAL HIP SYSTEM FOR CEMENTED APPLICATIONS. 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 September 17, 1996 after a review of 215 days - an extended review 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: 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 - K960647

510(k) Number K960647 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 1996
Decision Date September 17, 1996
Days to Decision 215 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
93d slower than avg
Panel avg: 122d · This submission: 215d
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 K960647.
S-ROM HIP SYSTEM - LOCKING PLUG
K963206 · Johnson & Johnson Professionals, Inc. · Oct 1996
AURA HIP SYSTEM CEMENTED FEMORAL STEM/CEMENTED LONG FEMORAL STEM
K961304 · Exactech, Inc. · Oct 1996
VITALITY HIP STEM
K962560 · Encore Orthopedics, Inc. · Sep 1996
SHP HIP SYSTEM-FEMORAL COMPONENTS/ACETABULAR COMPONENTS/MODULAR HEADS/CENTRALIZERS
K960984 · Biomet, Inc. · Sep 1996
PERFECTA PS REVISION STEM
K962267 · Wrightmedicaltechnologyinc · Sep 1996
COBALT-CHROMIUM-MOLYBDENUM (CO-CR-MO) ALLOY FEMORAL HEADS W/CO-NIDIUM SURFACE TREATMENT
K960278 · Zimmer, Inc. · Jul 1996