Cleared Special

K112059 - T2 FEMORAL NAIL MODEL 1825-XXXXCP

K112059 is an FDA 510(k) clearance for T2 FEMORAL NAIL MODEL 1825-XXXXCP, manufactured by Stryker. The device is a Class 2 Orthopedic device with product code HSB cleared through the Special 510(k) pathway after a 20-day FDA review.

K112059 · Stryker · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2011
Decision
20d
Days
Class 2
Risk

K112059 is an FDA 510(k) clearance for the T2 FEMORAL NAIL MODEL 1825-XXXXCP, 1828-XXXXCP. Classified as Rod, Fixation, Intramedullary And Accessories (product code HSB), Class II - Special Controls.

Submitted by Stryker (Mahwah, US). The FDA issued a Cleared decision on August 8, 2011 after a review of 20 days - a notably fast clearance cycle.

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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Stryker devices

FDA 510(k) Submission Details - K112059

510(k) Number K112059 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2011
Decision Date August 08, 2011
Days to Decision 20 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
102d faster than avg
Panel avg: 122d · This submission: 20d
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 365
Devices cleared under the same product code (HSB) and FDA review panel - the closest regulatory comparables to K112059.
SET SCREW FOR TI TROCHANTERIC FIXATION NAIL(TFN)
K120083 · Synthes (Usa) · Feb 2012
OSLEOBRIDGE IDSF SPACER CONECTOR
K113303 · Merete Medical GmbH · Dec 2011
SYNTHES BRAINLAB TRAUMA COMPATIBLE INSTRUMENTS
K111891 · Synthes USA Products, LLC · Nov 2011
TRIGEN LOW PROFILE BONE SCREW
K111025 · Smith & Nephew, Inc. · Jul 2011
UNIVERSAL AND TROCH ENTRY FEMORAL NAILING SYSTEMS LINE EXTENSION
K111444 · DePuy Orthopaedics, Inc. · Jun 2011
PICCOLO COMPOSITE NAILING SYSTEM
K111056 · CarboFix Orthopedics , Ltd. · May 2011