Cleared Special

K100475 - AXSOS LOCKED PLATING SYSTEM LINE EXTENS...

K100475 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 71-day FDA review.

K100475 · Howmedica Osteonics Corp. · Orthopedic device
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Apr 2010
Decision
71d
Days
Class 2
Risk

K100475 is an FDA 510(k) clearance for the AXSOS LOCKED PLATING SYSTEM LINE EXTENSION OF 5MM 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 April 30, 2010 after a review of 71 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 K100475 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2010
Decision Date April 30, 2010
Days to Decision 71 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
51d faster than avg
Panel avg: 122d · This submission: 71d
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 906
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K100475.
VARIAX ELBOW SYSTEM
K101056 · Howmedica Osteonics Corp. · May 2010
SYNTHES (USA) 2.7MM/ 3.5MM LCP ANTEROLATERAL DISTAL TIBIA PLATES
K092812 · Synthes (Usa) · May 2010
EXACTECH EQUINOXE PROXIMAL HUMERUS FRACTURE PLATE SYSTEM
K093978 · Exactech, Inc. · May 2010
PEANUT GROWTH CONTROL PLATING SYSTEM
K093880 · Ebi, L.P. · Apr 2010
DEROYAL NON-LOCKING BONE FIXATION SYSTEM
K090975 · Deroyal Industries, Inc. · Apr 2010
NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM
K100111 · Zimmer, Inc. · Apr 2010