Cleared Traditional

K801574 - DEPALMA ELBOW

K801574 is an FDA 510(k) clearance for DEPALMA ELBOW, manufactured by Zimmer, Inc.. The device is a Class 2 Orthopedic device with product code JDB cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K801574 · Zimmer, Inc. · Orthopedic device
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Oct 1980
Decision
114d
Days
Class 2
Risk

K801574 is an FDA 510(k) clearance for the DEPALMA ELBOW. Classified as Prosthesis, Elbow, Semi-constrained, Cemented (product code JDB), Class II - Special Controls.

Submitted by Zimmer, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 31, 1980 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 888.3160 - 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 Zimmer, Inc. devices

FDA 510(k) Submission Details - K801574

510(k) Number K801574 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 1980
Decision Date October 31, 1980
Days to Decision 114 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
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.

JDB Device Classification - Class 2, Special Controls

Product Code JDB Prosthesis, Elbow, Semi-constrained, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3160
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.