Cleared Traditional

K790774 - LODA WRIST PROSTHESIS

K790774 is an FDA 510(k) clearance for LODA WRIST PROSTHESIS, manufactured by Depuy, Inc.. The device is a Class 2 Orthopedic device with product code KWM cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K790774 · Depuy, Inc. · Orthopedic device
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Aug 1979
Decision
105d
Days
Class 2
Risk

K790774 is an FDA 510(k) clearance for the LODA WRIST PROSTHESIS. Classified as Prosthesis, Wrist, Semi-constrained (product code KWM), Class II - Special Controls.

Submitted by Depuy, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 3, 1979 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3800 - 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 - K790774

510(k) Number K790774 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1979
Decision Date August 03, 1979
Days to Decision 105 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
17d faster than avg
Panel avg: 122d · This submission: 105d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWM Device Classification - Class 2, Special Controls

Product Code KWM Prosthesis, Wrist, Semi-constrained
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3800
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.