Cleared Traditional

K940328 - PRIME CEMENTED HIP SYSTEM

K940328 is an FDA 510(k) clearance for PRIME CEMENTED HIP SYSTEM, manufactured by Orthopaedic Innovations, Inc.. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 438-day FDA review.

K940328 · Orthopaedic Innovations, Inc. · Orthopedic device
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Apr 1995
Decision
438d
Days
Class 2
Risk

K940328 is an FDA 510(k) clearance for the PRIME CEMENTED HIP SYSTEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Orthopaedic Innovations, Inc. (Minneapolis, US). The FDA issued a Cleared decision on April 7, 1995 after a review of 438 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Orthopaedic Innovations, Inc. devices

FDA 510(k) Submission Details - K940328

510(k) Number K940328 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received January 24, 1994
Decision Date April 07, 1995
Days to Decision 438 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
316d slower than avg
Panel avg: 122d · This submission: 438d
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 506
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K940328.
MALLORY-HEAD MODULAR CALCAR REPACEMENT COMPONENTS
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INDEX ACETABULAT COMPONENT
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ZIMMER MONOBLOC HIP PROSTHESIS WITH POLY (METHYL METHACRYLATE)
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