Cleared Traditional

K923275 - RMHS MONOLITHIC FEMORAL COMPONENT

K923275 is the FDA 510(k) clearance for RMHS MONOLITHIC FEMORAL COMPONENT by Smith & Nephew Richards, Inc.. It is a Class 2 Orthopedic device (product code JDI) cleared through the Traditional 510(k) pathway after a 276-day FDA review.

K923275 · Smith & Nephew Richards, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Apr 1993
Decision
276d
Days
Class 2
Risk

K923275 is an FDA 510(k) clearance for the RMHS MONOLITHIC FEMORAL COMPONENT. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Smith & Nephew Richards, Inc. (Memphis, US). The FDA issued a Cleared decision on April 8, 1993 after a review of 276 days - an extended review 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: 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 Smith & Nephew Richards, Inc. devices

Submission Details

510(k) Number K923275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1992
Decision Date April 08, 1993
Days to Decision 276 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
154d slower than avg
Panel avg: 122d · This submission: 276d
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 451
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K923275.
H-110 ACETABULAR CUP SYSTEM
K926323 · Implex Corp. · May 1993
IMPLEX H-110 AND H-120 CEMENTED HIP STEM SYSTEM
K925348 · Implex Corp. · May 1993
STABILITY HIP FEMORAL COMPONENT
K915594 · Depuy, Inc. · Apr 1993
PERFECTA TOTAL HIP SYSTEM
K922847 · Orthomet, Inc. · Apr 1993
TECHMEDICA CAD/CAM CUSTOM HIP
K911058 · Techmedica, Inc. · Feb 1993
THE UNIVERSAL BONE CEMENT RESISTOR
K924323 · Biodynamic Technologies, Inc. · Feb 1993