Cleared Special

K092671 - VARIAX ELBOW SYSTEM LINE EXTENSION

K092671 is an FDA 510(k) clearance for VARIAX ELBOW SYSTEM LINE EXTENSION, manufactured by Howmedica Osteonics Corp.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Special 510(k) pathway after a 23-day FDA review.

K092671 · Howmedica Osteonics Corp. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2009
Decision
23d
Days
Class 2
Risk

K092671 is an FDA 510(k) clearance for the VARIAX ELBOW SYSTEM LINE EXTENSION. 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 23, 2009 after a review of 23 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.

FDA 510(k) Submission Details - K092671

510(k) Number K092671 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2009
Decision Date September 23, 2009
Days to Decision 23 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
99d faster than avg
Panel avg: 122d · This submission: 23d
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 1332
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K092671.
ANKLE ARTHRODESIS PLATE SYSTEM
K090139 · Tornier, Inc. · Oct 2009
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K092381 · Ibalance Medical, Inc. · Oct 2009
SYNTHES LOCKING HAND PLATES
K092247 · Synthes (Usa) · Sep 2009
OSTEOMED FOOT PLATING SYSTEM
K091614 · Osteomed LP · Sep 2009
AXSOS LOCKED PLATING SYSTEM LINE EXTENSION OF 3MM LOCKING INSERTS
K092419 · Howmedica Osteonics Corp. · Sep 2009
WAVEON WRX BONE FIXATION SYSTEM
K090304 · Sonoma Orthopedic Products, Inc. · Aug 2009
K092671 · VARIAX ELBOW SYSTEM LINE EXTENSION
Download PDF FDA Summary Howmedica Osteonics C…