Cleared Traditional

K031555 - SYNTHES (USA) COMPARTMENTAL PRESSURE MONITORING SYSTEM

K031555 · Synthes (Usa) · Orthopedic device
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Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K031555

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 122d · This submission: 50d
Pathway characteristics
Predicate-based equivalence.

LXC Device Classification - Class 0,

Product Code LXC Monitor, Pressure, Intracompartmental
Device Class -

Regulatory Peers - LXC Monitor, Pressure, Intracompartmental

All 12
Devices cleared under the same product code (LXC) and FDA review panel - the closest regulatory comparables to K031555.
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