Cleared Traditional

K915391 - FPC HIP STEM COMPONENT

K915391 is an FDA 510(k) clearance for FPC 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 518-day FDA review.

K915391 · Implantology Corp. · Orthopedic device
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Apr 1993
Decision
518d
Days
Class 2
Risk

K915391 is an FDA 510(k) clearance for the FPC 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 518 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Implantology Corp. devices

FDA 510(k) Submission Details - K915391

510(k) Number K915391 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1991
Decision Date April 30, 1993
Days to Decision 518 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
396d slower than avg
Panel avg: 122d · This submission: 518d
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 K915391.
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