Cleared Traditional

K942537 - PARAMOUNT CEMENTED HIP STEM PROTHESIS

K942537 is an FDA 510(k) clearance for PARAMOUNT CEMENTED HIP STEM PROTHESIS, manufactured by Depuy, Inc.. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 227-day FDA review.

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

FDA 510(k) Submission Details - K942537

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.

JDI Device Classification - Class 2, Special Controls

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 516
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K942537.
PROVIDENT HP SYSTEM
K946371 · Stelkast Company · Apr 1995
FOUNDATION NON-POROUS STEM
K935449 · Encore Orthopedics, Inc. · Mar 1995
HOWMEDICA STRAIGHT STEM FEMORAL COMPONENT
K940307 · Howmedica, Inc. · Jan 1995
RESTORATION ACETABULAR CUP
K943549 · Osteonics Corp. · Dec 1994
PERFECTA TOTAL HIP SYSTEM COATED COCR FEMORAL STEM
K930771 · Orthomet, Inc. · Nov 1994
DEPUY CEMENTED HIP PROSTHESIS
K942370 · Depuy, Inc. · Nov 1994