Cleared Traditional

K132218 - PERFIX ILIAC SCREW SYSTEM

K132218 is the FDA 510(k) clearance for PERFIX ILIAC SCREW SYSTEM by U&I Corporation. It is a Class 2 Orthopedic device (product code MNH) cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K132218 · U&I Corporation · Orthopedic device
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Dec 2013
Decision
153d
Days
Class 2
Risk

K132218 is an FDA 510(k) clearance for the PERFIX ILIAC SCREW SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by U&I Corporation (Uijeongbu-Si, Gyeonggi-Do, KR). The FDA issued a Cleared decision on December 17, 2013 after a review of 153 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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 U&I Corporation devices

Submission Details

510(k) Number K132218 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2013
Decision Date December 17, 2013
Days to Decision 153 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
31d slower than avg
Panel avg: 122d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 155
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K132218.
Romeo posterior osteosynthesis system
K151695 · Spineart · Sep 2015
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
K140948 · Spineart · May 2014
ANNEXTM ADJACENT LEVEL SYSTEM
K132403 · Spine Wave, Inc. · Jan 2014
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM
K130267 · Spineart · May 2013
FORTEX PEDICLE SCREW SYSTEM
K120832 · X-Spine Systems, Inc. · Oct 2012
RANGE SPINAL SYSTEM (MESA AND DENALI)
K121016 · K2m, Inc. · Jun 2012