Cleared Traditional

IMPACT CO-CR 1-PIECE FEMORAL COMPONENT (K942027) - FDA 510(k) Clearance

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

K942027 · Biomet, Inc. · Orthopedic device
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Sep 1994
Decision
146d
Days
Class 2
Risk

K942027 is an FDA 510(k) clearance for the IMPACT CO-CR 1-PIECE FEMORAL COMPONENT. Classified as Prosthesis, Hip, Femoral Component, Cemented, Metal (product code JDG), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on September 19, 1994 after a review of 146 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Biomet, Inc. devices

Submission Details

510(k) Number K942027 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received April 26, 1994
Decision Date September 19, 1994
Days to Decision 146 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 122d · This submission: 146d
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 25
Devices cleared under the same product code (JDG) and FDA review panel - the closest regulatory comparables to K942027.
AURA HIP SYSTEM CALCAR REPLACEMENT FEMORAL STEM
K962002 · Exactech, Inc. · Aug 1996
HIP FRACTURE STEM FENESTRATION PLUG
K953067 · Howmedica Corp. · Aug 1995
INTEGRAL CO-CR FEMORAL COMPONENT
K942479 · Biomet, Inc. · Sep 1994
RX90 FEMORAL COMPONENT
K942028 · Biomet, Inc. · Sep 1994
CO-CR ANSWER FEMORAL COMPONENT
K931194 · Biomet, Inc. · May 1994
BRIDGE(TM) HIP SYSTEM
K933871 · Wrightmedicaltechnologyinc · Feb 1994