Cleared Traditional

K120807 - SYNTHES MULTILOC HUMERAL NAILING SYSTEM

K120807 is the FDA 510(k) clearance for SYNTHES MULTILOC HUMERAL NAILING SYSTEM by Synthes USA Products, LLC. It is a Class 2 Orthopedic device (product code HSB) cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K120807 · Synthes USA Products, LLC · Orthopedic device
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Jul 2012
Decision
112d
Days
Class 2
Risk

K120807 is an FDA 510(k) clearance for the SYNTHES MULTILOC HUMERAL NAILING SYSTEM. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Synthes USA Products, LLC (West Chester, US). The FDA issued a Cleared decision on July 6, 2012 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3020 - 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 Synthes USA Products, LLC devices

Submission Details

510(k) Number K120807 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2012
Decision Date July 06, 2012
Days to Decision 112 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
10d faster than avg
Panel avg: 122d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HSB Rod, Fixation, Intramedullary And Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3020
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 - HSB Rod, Fixation, Intramedullary And Accessories

All 337
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K120807.
PICCOLO COMPOSITE ANKLE ARTHRODESIS NAILING SYSTEM
K123810 · CarboFix Orthopedics , Ltd. · Jun 2013
SMITH & NEPHEW, INC. INTRAMEDULLARY NAIL SYSTEM INSTRUMENTATION
K122170 · Smith & Nephew, Inc. · Oct 2012
ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY FEMORAL NAIL - ASIA SHORT
K120715 · Zimmer GmbH · Aug 2012
S2 FEMORAL A/R NAIL S2 FEMORAL COMRESSION NAIL S2 TIBIAL NAIL S2 TIBIAL COMPRESSION NAIL
K113409 · Howmedica Osteonics Corp. · Feb 2012
SET SCREW FOR TI TROCHANTERIC FIXATION NAIL(TFN)
K120083 · Synthes (Usa) · Feb 2012
SYNTHES BRAINLAB TRAUMA COMPATIBLE INSTRUMENTS
K111891 · Synthes USA Products, LLC · Nov 2011