Cleared Traditional

PARAMOUNT CEMENTED HIP STEM PROTHESIS (K942537) - FDA 510(k) Clearance

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

K942537 · Depuy, Inc. · Orthopedic device
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Jan 1995
Decision
227d
Days
Class 2
Risk

K942537 is an FDA 510(k) clearance for the PARAMOUNT CEMENTED HIP STEM PROTHESIS. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on January 9, 1995 after a review of 227 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 Depuy, Inc. devices

Submission Details

510(k) Number K942537 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received May 27, 1994
Decision Date January 09, 1995
Days to Decision 227 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
105d slower than avg
Panel avg: 122d · This submission: 227d
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 279
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K942537.
MALLORY-HEAD MODULAR CALCAR REPACEMENT COMPONENTS
K945115 · Biomet, Inc. · May 1995
INDEX ACETABULAT COMPONENT
K950761 · Biomet, Inc. · May 1995
ZIMMER MONOBLOC HIP PROSTHESIS WITH POLY (METHYL METHACRYLATE)
K944792 · Zimmer, Inc. · Apr 1995
RESTORATION ACETABULAR CUP
K943549 · Osteonics Corp. · Dec 1994
DEPUY CEMENTED HIP PROSTHESIS
K942370 · Depuy, Inc. · Nov 1994
AML TRILOCK REPLACEMENT LINER SYSTEM
K942966 · Depuy, Inc. · Oct 1994