Cleared Traditional

K031555 - SYNTHES (USA) COMPARTMENTAL PRESSURE MONITORING SYSTEM (FDA 510(k) Clearance)

K031555 · Synthes (Usa) · Orthopedic device
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Jul 2003
Decision
50d
Days
-
Risk

K031555 is an FDA 510(k) clearance for the SYNTHES (USA) COMPARTMENTAL PRESSURE MONITORING SYSTEM. Classified as Monitor, Pressure, Intracompartmental (product code LXC).

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on July 8, 2003 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Orthopedic 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Synthes (Usa) devices

Submission Details

510(k) Number K031555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2003
Decision Date July 08, 2003
Days to Decision 50 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
72d faster than avg
Panel avg: 122d · This submission: 50d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LXC Monitor, Pressure, Intracompartmental
Device Class -