Cleared Traditional

K931642 - RMHS MONOLITHIC FEMORAL COMPONENT

K931642 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 LPH) cleared through the Traditional 510(k) pathway after a 392-day FDA review.

K931642 · Smith & Nephew Richards, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Apr 1994
Decision
392d
Days
Class 2
Risk

K931642 is an FDA 510(k) clearance for the RMHS MONOLITHIC FEMORAL COMPONENT. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Smith & Nephew Richards, Inc. (Memphis, US). The FDA issued a Cleared decision on April 29, 1994 after a review of 392 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - 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. Elevated predicate reliance profile. 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 K931642 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1993
Decision Date April 29, 1994
Days to Decision 392 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
270d slower than avg
Panel avg: 122d · This submission: 392d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3358
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 - LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

All 446
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K931642.
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REFLECTION ACETABULAR COMPONENT
K932755 · Smith & Nephew Richards, Inc. · May 1994
IMPLEX A-230 POROUS ACETABULAR CUP SYST.CEMENTLESS
K932923 · Implex Corp. · May 1994
TRILOGY ACETABULAR SYSTEM
K934765 · Zimmer, Inc. · Apr 1994
POROCOAT POROUS COATING/AML PROXIMALLY-COATED STEM
K933787 · Depuy, Inc. · Apr 1994
POROCOAT POROUS COATING
K931641 · Depuy, Inc. · Mar 1994