Cleared Traditional

K120070 - SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM

K120070 is the FDA 510(k) clearance for SYNTHES VARIABLE ANGLE LCP ELBOW SYSTEM by Synthes (Usa). It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K120070 · Synthes (Usa) · Orthopedic device
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Mar 2012
Decision
72d
Days
Class 2
Risk

K120070 is an FDA 510(k) clearance for the SYNTHES VARIABLE ANGLE LCP ELBOW 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 March 21, 2012 after a review of 72 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 K120070 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 2012
Decision Date March 21, 2012
Days to Decision 72 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
50d faster than avg
Panel avg: 122d · This submission: 72d
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 K120070.
APTUS PROXIMAL HUMERUS SYSTEM
K120108 · Medartis AG · Apr 2012
VLP 2.7MM EXTRA LARGE PERCUTANEOUS CALCANEUS PLATE, PERI-LOC 3.5MM ANTERIOR ANKLE FUSION PLATES, PERI-LOC 3.5MM HINDFOOT
K120667 · Smith & Nephew, Inc. · Apr 2012
ORTHOLOC(TM) 3DI LOCKING SCREWS ORTHOLOC(TM) BONE SCREWS
K120802 · Wrightmedicaltechnologyinc · Apr 2012
TRAUMA INTERNAL FIXATION SYSTEMS
K111663 · DePuy Orthopaedics, Inc. · Mar 2012
2.7MM LCP ULNA OSTEOTOMY SYSTEM
K113364 · Synthes USA Products, LLC · Feb 2012
CLAW II POLYAXIAL COMPRESSION SYSTEM AND ORTHOLOC 3DSI LOCKING SCREWS
K113014 · Wrightmedicaltechnologyinc · Jan 2012