Cleared Traditional

PROFORM CEMENTED FEMORAL COMPONENT (K951083) - FDA 510(k) Clearance

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

K951083 · Stelkast Company · Orthopedic device
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May 1995
Decision
74d
Days
Class 2
Risk

K951083 is an FDA 510(k) clearance for the PROFORM CEMENTED FEMORAL COMPONENT. Classified as Prosthesis, Hip, Femoral Component, Cemented, Metal (product code JDG), Class II - Special Controls.

Submitted by Stelkast Company (Pittsburgh, US). The FDA issued a Cleared decision on May 22, 1995 after a review of 74 days - a notably fast clearance 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: 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 K951083 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 09, 1995
Decision Date May 22, 1995
Days to Decision 74 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 122d · This submission: 74d
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.

Regulatory Peers - JDG Prosthesis, Hip, Femoral Component, Cemented, Metal

All 22
Devices cleared under the same product code (JDG) and FDA review panel - the closest regulatory comparables to K951083.
Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads
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HIP FRACTURE STEM FENESTRATION PLUG
K953067 · Howmedica Corp. · Aug 1995
INTEGRAL CO-CR FEMORAL COMPONENT
K942479 · Biomet, Inc. · Sep 1994
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K942027 · Biomet, Inc. · Sep 1994
RX90 FEMORAL COMPONENT
K942028 · Biomet, Inc. · Sep 1994