Cleared Traditional

K803031 - LAURE WRIST IMPLANT (FDA 510(k) Clearance)

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

K803031 · Laure Prosthetics, Inc. · Orthopedic device
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Jun 1982
Decision
578d
Days
Class 2
Risk

K803031 is an FDA 510(k) clearance for the LAURE WRIST IMPLANT. Classified as Prosthesis, Wrist, Semi-constrained (product code KWM), Class II - Special Controls.

Submitted by Laure Prosthetics, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 29, 1982 after a review of 578 days - an unusually long review period, suggesting complex equivalence evaluation.

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: 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 Laure Prosthetics, Inc. devices

Submission Details

510(k) Number K803031 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1980
Decision Date June 29, 1982
Days to Decision 578 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
456d slower than avg
Panel avg: 122d · This submission: 578d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.