Cleared Traditional

MODULAR HIP SYSTEM (K912593) - FDA 510(k) Clearance

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

K912593 · Smith & Nephew Richards, Inc. · Orthopedic device
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Oct 1991
Decision
114d
Days
Class 2
Risk

K912593 is an FDA 510(k) clearance for the MODULAR HIP SYSTEM. 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 October 2, 1991 after a review of 114 days - within the typical 510(k) review window.

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 K912593 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1991
Decision Date October 02, 1991
Days to Decision 114 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 122d · This submission: 114d
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 280
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K912593.
PT II DISTAL CEMENT SPACER
K914406 · Osteonics Corp. · Dec 1991
OMNIFIT/OMNIFLEX/ODC/OMNIFIT-HA HIP STEM SERIES
K913812 · Osteonics Corp. · Nov 1991
MODULAR CALCAR REPLACEMENT
K913649 · Zimmer, Inc. · Nov 1991
UHMWP ACETABULAR COMPONENT
K912426 · Howmedica Corp. · Aug 1991
OSTEONICS(R) PRT HIP STEM SERIES
K911890 · Osteonics Corp. · Jul 1991
M.A.R.A. (MODULAR ACETABULAR RECONSTRUCTION SYST)
K911718 · Biomet, Inc. · Jul 1991