Cleared Traditional

K090047 - SYNTHES (USA) 1.5MM MINI FRAGMENT LCP S...

K090047 is the FDA 510(k) clearance for SYNTHES (USA) 1.5MM MINI FRAGMENT LCP S... by Synthes (Usa). It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K090047 · Synthes (Usa) · Orthopedic device
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Apr 2009
Decision
84d
Days
Class 2
Risk

K090047 is an FDA 510(k) clearance for the SYNTHES (USA) 1.5MM MINI FRAGMENT LCP SYSTEM. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Synthes (Usa) (West Chester, US). The FDA issued a Cleared decision on April 1, 2009 after a review of 84 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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: 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 K090047 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 07, 2009
Decision Date April 01, 2009
Days to Decision 84 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
38d faster than avg
Panel avg: 122d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - HRS Plate, Fixation, Bone

All 902
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K090047.
ORTHOLOC 2.0/2.4 PLATE SYSTEM
K090692 · Wrightmedicaltechnologyinc · May 2009
PEDIPLATES
K090666 · OrthoPediatrics Corp. · Apr 2009
APTUS 2.0 RADIAL HEAD SYSTEM
K090053 · Medartis AG · Apr 2009
1.5MM SMALL LOCKING PLATE, 1.5MM NON-LOCKING AND LOCKING SCREWS
K090492 · DePuy Orthopaedics, Inc. · Mar 2009
LOCKING ANATOMIC & COMPOSITE PLATING SYSTEM
K083843 · DePuy Orthopaedics, Inc. · Mar 2009
SYNTHES (USA) 2.4 MM VA-LCP TWO COLUMN VOLAR DISTAL RADIUS PLATES
K083694 · Synthes (Usa) · Mar 2009