Cleared Traditional

ORTHOMET TITANIUM HYBRID FEMORAL STEM (K945783) - FDA 510(k) Clearance

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

K945783 · Orthomet, Inc. · Orthopedic device
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May 1995
Decision
186d
Days
Class 2
Risk

K945783 is an FDA 510(k) clearance for the ORTHOMET TITANIUM HYBRID FEMORAL STEM. Classified as Prosthesis, Hip, Femoral Component, Cemented, Metal (product code JDG), Class II - Special Controls.

Submitted by Orthomet, Inc. (Minneapolis, US). The FDA issued a Cleared decision on May 30, 1995 after a review of 186 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3360 - 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 Orthomet, Inc. devices

Submission Details

510(k) Number K945783 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1994
Decision Date May 30, 1995
Days to Decision 186 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 122d · This submission: 186d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDG Prosthesis, Hip, Femoral Component, Cemented, Metal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3360
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 - JDG Prosthesis, Hip, Femoral Component, Cemented, Metal

All 26
Devices cleared under the same product code (JDG) and FDA review panel - the closest regulatory comparables to K945783.
Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads
K173499 · Stryker Orthopaedics · Mar 2018
AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEM
K962002 · Exactech, Inc. · Aug 1996
HIP FRACTURE STEM FENESTRATION PLUG
K953067 · Howmedica Corp. · Aug 1995
INTEGRAL CO-CR FEMORAL COMPONENT
K942479 · Biomet, Inc. · Sep 1994
IMPACT CO-CR 1-PIECE FEMORAL COMPONENT
K942027 · Biomet, Inc. · Sep 1994
RX90 FEMORAL COMPONENT
K942028 · Biomet, Inc. · Sep 1994