Cleared Traditional

K942028 - RX90 FEMORAL COMPONENT

K942028 is an FDA 510(k) clearance for RX90 FEMORAL COMPONENT, manufactured by Biomet, Inc.. The device is a Class 2 Orthopedic device with product code JDG cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K942028 · Biomet, Inc. · Orthopedic device
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Sep 1994
Decision
146d
Days
Class 2
Risk

K942028 is an FDA 510(k) clearance for the RX90 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

FDA 510(k) Submission Details - K942028

510(k) Number K942028 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.

JDG Device Classification - Class 2, Special Controls

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 47
Devices cleared under the same product code (JDG) and FDA review panel - the closest regulatory comparables to K942028.
PROFORM CEMENTED FEMORAL COMPONENT
K951083 · Stelkast Company · May 1995
INTEGRAL CO-CR FEMORAL COMPONENT
K942479 · Biomet, Inc. · Sep 1994
IMPACT CO-CR 1-PIECE FEMORAL COMPONENT
K942027 · Biomet, Inc. · Sep 1994
CO-CR ANSWER FEMORAL COMPONENT
K931194 · Biomet, Inc. · May 1994
S-ROM TOTAL HIP REPLACEMENT SYSTEM
K935078 · Joint Medical Products Corp. · Mar 1994
BRIDGE(TM) HIP SYSTEM
K933871 · Wrightmedicaltechnologyinc · Feb 1994