Cleared Traditional

K970544 - DEPUY DUPONT ORTHOPAEDICS FINGER JOINT PROSTHESIS (FDA 510(k) Clearance)

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

K970544 · Depuy, Inc. · Orthopedic device
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Sep 1997
Decision
212d
Days
Class 2
Risk

K970544 is an FDA 510(k) clearance for the DEPUY DUPONT ORTHOPAEDICS FINGER JOINT PROSTHESIS. Classified as Prosthesis, Finger, Constrained, Polymer (product code KYJ), Class II - Special Controls.

Submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on September 12, 1997 after a review of 212 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3230 - 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 K970544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1997
Decision Date September 12, 1997
Days to Decision 212 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 122d · This submission: 212d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KYJ Prosthesis, Finger, Constrained, Polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3230
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.