Cleared Traditional

K924099 - UFC HIP STEM COMPONENT

K924099 is an FDA 510(k) clearance for UFC HIP STEM COMPONENT, manufactured by Implantology Corp.. The device is a Class 2 Orthopedic device with product code JDG cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K924099 · Implantology Corp. · Orthopedic device
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Apr 1993
Decision
260d
Days
Class 2
Risk

K924099 is an FDA 510(k) clearance for the UFC HIP STEM COMPONENT. Classified as Prosthesis, Hip, Femoral Component, Cemented, Metal (product code JDG), Class II - Special Controls.

Submitted by Implantology Corp. (Pine Brook, US). The FDA issued a Cleared decision on April 30, 1993 after a review of 260 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 Implantology Corp. devices

FDA 510(k) Submission Details - K924099

510(k) Number K924099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1992
Decision Date April 30, 1993
Days to Decision 260 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
138d slower than avg
Panel avg: 122d · This submission: 260d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDG Device Classification - Class 2, Special Controls

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 48
Devices cleared under the same product code (JDG) and FDA review panel - the closest regulatory comparables to K924099.
CO-CR ANSWER FEMORAL COMPONENT
K931194 · Biomet, Inc. · May 1994
S-ROM TOTAL HIP REPLACEMENT SYSTEM
K935078 · Joint Medical Products Corp. · Mar 1994
BRIDGE(TM) HIP SYSTEM
K933871 · Wrightmedicaltechnologyinc · Feb 1994
STABILITY HIP STEM WITH POROCOAT
K915787 · Depuy, Inc. · Apr 1993
AMERICANA HIP PROTHESIS
K922682 · Osteo Technology, Inc. · Mar 1993
INFINITY(TM) POROUS-COATED TROCHANTERIC MODULE
K911595 · Dow Corning Wright · Jul 1991