Cleared Traditional

K910712 - VILLAN (VIDEO LIFT LINK ANALYSIS)

K910712 is an FDA 510(k) clearance for VILLAN (VIDEO LIFT LINK ANALYSIS), manufactured by Physio Systems, Inc.. The device is a Class 1 Orthopedic device with product code LXI cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K910712 · Physio Systems, Inc. · Orthopedic device
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May 1991
Decision
90d
Days
Class 1
Risk

K910712 is an FDA 510(k) clearance for the VILLAN (VIDEO LIFT LINK ANALYSIS). Classified as Guide, Drill, Ligament (product code LXI), Class I - General Controls.

Submitted by Physio Systems, Inc. (Fremont, US). The FDA issued a Cleared decision on May 21, 1991 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 878.4820 - 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 Physio Systems, Inc. devices

FDA 510(k) Submission Details - K910712

510(k) Number K910712 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1991
Decision Date May 21, 1991
Days to Decision 90 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

LXI Device Classification - Class 1, General Controls

Product Code LXI Guide, Drill, Ligament
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4820
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.