Cleared Traditional

K113044 - SYNTHES MIRS

K113044 is an FDA 510(k) clearance for SYNTHES MIRS, manufactured by Synthes Spine. The device is a Class 2 Orthopedic device with product code NKB cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K113044 · Synthes Spine · Orthopedic device
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Dec 2011
Decision
70d
Days
Class 2
Risk

K113044 is an FDA 510(k) clearance for the SYNTHES MIRS. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Synthes Spine (West Chester, US). The FDA issued a Cleared decision on December 21, 2011 after a review of 70 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. 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 Spine devices

FDA 510(k) Submission Details - K113044

510(k) Number K113044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 2011
Decision Date December 21, 2011
Days to Decision 70 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
52d faster than avg
Panel avg: 122d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NKB Device Classification - Class 2, Special Controls

Product Code NKB Thoracolumbosacral Pedicle Screw System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.
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 - NKB Thoracolumbosacral Pedicle Screw System

All 890
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K113044.
LEUCADIA AUTOLOK PEDICLE SCREW SYSTEM
K113366 · Phygen, LLC · Jan 2012
DSS STABILIZATION SYSTEM
K113625 · Paradigm Spine, LLC · Jan 2012
FOCUS MIS SYSTEM
K112643 · L & K Biomed Co., Ltd. · Jan 2012
LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS)
K113434 · Lanx, Inc. · Dec 2011
INSTINCT JAVA SYSTEM
K113270 · Zimmer Spine · Dec 2011
ATHENA PEDICLE SCREW SYSTEM
K110046 · Royal Oak Medical Devices · Dec 2011