Cleared Special

K092419 - AXSOS LOCKED PLATING SYSTEM LINE EXTENS...

K092419 is the FDA 510(k) clearance for AXSOS LOCKED PLATING SYSTEM LINE EXTENS... by Howmedica Osteonics Corp.. It is a Class 2 Orthopedic device (product code HRS) cleared through the Special 510(k) pathway after a 26-day FDA review.

K092419 · Howmedica Osteonics Corp. · Orthopedic device
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Sep 2009
Decision
26d
Days
Class 2
Risk

K092419 is an FDA 510(k) clearance for the AXSOS LOCKED PLATING SYSTEM LINE EXTENSION OF 3MM LOCKING INSERTS. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Mahwah, US). The FDA issued a Cleared decision on September 1, 2009 after a review of 26 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 Howmedica Osteonics Corp. devices

Submission Details

510(k) Number K092419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2009
Decision Date September 01, 2009
Days to Decision 26 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
96d faster than avg
Panel avg: 122d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 904
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K092419.
ANKLE ARTHRODESIS PLATE SYSTEM
K090139 · Tornier, Inc. · Oct 2009
SYNTHES LOCKING HAND PLATES
K092247 · Synthes (Usa) · Sep 2009
VARIAX ELBOW SYSTEM LINE EXTENSION
K092671 · Howmedica Osteonics Corp. · Sep 2009
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM
K092015 · Smith & Nephew, Inc. · Jul 2009
LATERAL COLUMN LENGTH PLATE, MODEL 824073000-3, LOCKED FUSION PLATE, MODEL 824077010, COMPRESSION FUSION PLATE,
K091294 · DePuy Orthopaedics, Inc. · Jul 2009
TRIMED STERILE PRODUCT
K091156 · TriMed, Inc. · Jul 2009