Cleared Special

K113109 - STRYKER RESORBABLE FIXATION SYSTEM

K113109 is an FDA 510(k) clearance for STRYKER RESORBABLE FIXATION SYSTEM, manufactured by Stryker. The device is a Class 2 Orthopedic device with product code HRS cleared through the Special 510(k) pathway after a 64-day FDA review.

K113109 · Stryker · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2011
Decision
64d
Days
Class 2
Risk

K113109 is an FDA 510(k) clearance for the STRYKER RESORBABLE FIXATION 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 Stryker (Porage, US). The FDA issued a Cleared decision on December 23, 2011 after a review of 64 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. 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 - K113109

510(k) Number K113109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 2011
Decision Date December 23, 2011
Days to Decision 64 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
58d faster than avg
Panel avg: 122d · This submission: 64d
Pathway characteristics
Modification to existing cleared device.

HRS Device Classification - Class 2, Special Controls

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 1005
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K113109.
MAXLOCK EXTREME SYSTEM
K113048 · Orthohelix Surgical Designs, Inc. · Jan 2012
NCB STRAIGHT NARROW SHAFT PLATES
K113718 · Zimmer GmbH · Jan 2012
APTUS WRIST ARTHRODESIS PLATES
K112169 · Medartis AG · Jan 2012
AXSOS LOCKING PLATE SYSTEM
K112926 · Stryker Corp. · Dec 2011
APTUS(R) DISTAL HUMERUS SYSTEM
K112560 · Medartis AG · Dec 2011
ORTHOLOC 3DSI LOCKING SCREWS
K113339 · Wrightmedicaltechnologyinc · Dec 2011