Cleared Special

K031290 - MODIFICATION TO EASYS TRANSVERSE CONNECTION

K031290 is an FDA 510(k) clearance for MODIFICATION TO EASYS TRANSVERSE CONNECTION, manufactured by Scient'X USA, Inc.. The device is a Class 2 Orthopedic device with product code MNH cleared through the Special 510(k) pathway after a 20-day FDA review.

K031290 · Scient'X USA, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2003
Decision
20d
Days
Class 2
Risk

K031290 is an FDA 510(k) clearance for the MODIFICATION TO EASYS TRANSVERSE CONNECTION. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Scient'X USA, Inc. (Round Rock, US). The FDA issued a Cleared decision on May 13, 2003 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K031290

510(k) Number K031290 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2003
Decision Date May 13, 2003
Days to Decision 20 days
Submission Type Special
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
102d faster than avg
Panel avg: 122d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

MNH Device Classification - Class 2, Special Controls

Product Code MNH Orthosis, Spondylolisthesis Spinal Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
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.

Regulatory Peers - MNH Orthosis, Spondylolisthesis Spinal Fixation

All 308
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K031290.
EBI P148 SPINAL FIXATION SYSTEM
K031423 · Ebi, L.P. · Jun 2003
U&I, OPTIMA, SPINAL SYSTEM
K031585 · U&I Corp., America · Jun 2003
BLACKSTONE SPINAL FIXATION SYSTEM LATERAL OFFSET (SYSTEM MODIFICATION)
K030581 · Blackstone Medical, Inc. · Jun 2003
MODIFICATION TO MOSS MIAMI SPINAL SYSTEM POLYAXIAL SCREWS
K030383 · Depuyacromed · Feb 2003
ORIA SPINAL CLIP SYSTEM, TYPES BD AND BJ
K023994 · Ortho Tec, LLC · Feb 2003
MONARCH SPINE SYSTEM
K024348 · Depuyacromed · Jan 2003
K031290 · MODIFICATION TO EASYS TRANSVERSE CONNECTION
Download PDF FDA Summary Scient'X USA, Inc.