Cleared Traditional

FOUNDATION NON-POROUS STEM (K935449) - FDA 510(k) Clearance

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

K935449 · Encore Orthopedics, Inc. · Orthopedic device
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Mar 1995
Decision
503d
Days
Class 2
Risk

K935449 is an FDA 510(k) clearance for the FOUNDATION NON-POROUS STEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Encore Orthopedics, Inc. (Austin, US). The FDA issued a Cleared decision on March 30, 1995 after a review of 503 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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 Encore Orthopedics, Inc. devices

Submission Details

510(k) Number K935449 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1993
Decision Date March 30, 1995
Days to Decision 503 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
381d slower than avg
Panel avg: 122d · This submission: 503d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 280
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K935449.
MALLORY-HEAD MODULAR CALCAR REPACEMENT COMPONENTS
K945115 · Biomet, Inc. · May 1995
INDEX ACETABULAT COMPONENT
K950761 · Biomet, Inc. · May 1995
ZIMMER MONOBLOC HIP PROSTHESIS WITH POLY (METHYL METHACRYLATE)
K944792 · Zimmer, Inc. · Apr 1995
PARAMOUNT CEMENTED HIP STEM PROTHESIS
K942537 · Depuy, Inc. · Jan 1995
RESTORATION ACETABULAR CUP
K943549 · Osteonics Corp. · Dec 1994
DEPUY CEMENTED HIP PROSTHESIS
K942370 · Depuy, Inc. · Nov 1994