Cleared Traditional

K915385 - PPC HIP STEM COMPONENT (FDA 510(k) Clearance)

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

K915385 · Implantology Corp. · Orthopedic device
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May 1993
Decision
535d
Days
Class 2
Risk

K915385 is an FDA 510(k) clearance for the PPC 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 May 17, 1993 after a review of 535 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

Submission Details

510(k) Number K915385 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received November 29, 1991
Decision Date May 17, 1993
Days to Decision 535 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
413d slower than avg
Panel avg: 122d · This submission: 535d
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.