Cleared Traditional

K920286 - DEPUY TOTAL HIP BALLS - ION IMPLANTATION

K920286 is the FDA 510(k) clearance for DEPUY TOTAL HIP BALLS - ION IMPLANTATION by Depuy, Inc.. It is a Class 2 Orthopedic device (product code JDI) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K920286 · Depuy, Inc. · Orthopedic device
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Apr 1992
Decision
90d
Days
Class 2
Risk

K920286 is an FDA 510(k) clearance for the DEPUY TOTAL HIP BALLS - ION IMPLANTATION. 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 April 21, 1992 after a review of 90 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 Depuy, Inc. devices

Submission Details

510(k) Number K920286 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1992
Decision Date April 21, 1992
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
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 451
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