Cleared Traditional

PROFORM CEMENTED TITANIUM REVISION FEMORAL COMPONENT (K970194) - FDA 510(k) Clearance

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

K970194 · Stelkast Company · Orthopedic device
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Apr 1997
Decision
83d
Days
Class 2
Risk

K970194 is an FDA 510(k) clearance for the PROFORM CEMENTED TITANIUM REVISION FEMORAL COMPONENT. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Stelkast Company (Pittsburgh, US). The FDA issued a Cleared decision on April 14, 1997 after a review of 83 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Stelkast Company devices

Submission Details

510(k) Number K970194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1997
Decision Date April 14, 1997
Days to Decision 83 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
39d faster than avg
Panel avg: 122d · This submission: 83d
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 K970194.
RECOVERY PROTRUSIO CAGE
K971890 · Biomet, Inc. · Aug 1997
DURATION STABILIZED UHMWPE
K963612 · Howmedica Corp. · Jun 1997
OSTEONICS NORMALIZED AD ACETABULAR COMPONENT SYSTEM
K970697 · Osteonics Corp. · Apr 1997
CEMENTED CALCAR REPLACEMENT FEMORAL STEM
K964795 · Johnson & Johnson Professionals, Inc. · Feb 1997
UHMWPE HIP AND KNEE COMPONENTS - PACKAGING CHANGE
K964655 · Howmedica Corp. · Feb 1997
OSTEONICS FLANGED POLYETHYLENE ACETABULAR CUP
K963671 · Osteonics Corp. · Feb 1997