Cleared Traditional

ARTHROSTIM MANIPULATOR (K930431) - FDA 510(k) Clearance

K930431 · Freeman Procedure Seminars · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1994
Decision
535d
Days
-
Risk

K930431 is an FDA 510(k) clearance for the ARTHROSTIM MANIPULATOR. Classified as Manipulator, Plunger-like Joint (product code LXM).

Submitted by Freeman Procedure Seminars (Salem, US). The FDA issued a Cleared decision on July 15, 1994 after a review of 535 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel. 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 Physical Medicine submissions.

View all Freeman Procedure Seminars devices

Submission Details

510(k) Number K930431 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1993
Decision Date July 15, 1994
Days to Decision 535 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
420d slower than avg
Panel avg: 115d · This submission: 535d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LXM Manipulator, Plunger-like Joint
Device Class -