Cleared Special

K111891 - SYNTHES BRAINLAB TRAUMA COMPATIBLE INSTRUMENTS

K111891 is an FDA 510(k) clearance for SYNTHES BRAINLAB TRAUMA COMPATIBLE INST..., manufactured by Synthes USA Products, LLC. The device is a Class 2 Orthopedic device with product code HSB cleared through the Special 510(k) pathway after a 146-day FDA review.

K111891 · Synthes USA Products, LLC · Orthopedic device
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Nov 2011
Decision
146d
Days
Class 2
Risk

K111891 is an FDA 510(k) clearance for the SYNTHES BRAINLAB TRAUMA COMPATIBLE INSTRUMENTS. 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 November 28, 2011 after a review of 146 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Synthes USA Products, LLC devices

FDA 510(k) Submission Details - K111891

510(k) Number K111891 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2011
Decision Date November 28, 2011
Days to Decision 146 days
Submission Type Special
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
24d slower than avg
Panel avg: 122d · This submission: 146d
Pathway characteristics
Modification to existing cleared device.

HSB Device Classification - Class 2, Special Controls

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 468
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K111891.
SET SCREW FOR TI TROCHANTERIC FIXATION NAIL(TFN)
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SONOMA FASTRAC CLAVICLE FRACTURE REPAIR DEVICE MODEL SONOMA FASTRAC XXYYY(X=DIA, YYY=LENGTH- IN MM)
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T2 FEMORAL NAIL MODEL 1825-XXXXCP, 1828-XXXXCP
K112059 · Stryker · Aug 2011