Cleared Special

K100676 - SYNTHES TOMOFIX(TM) MEIAL HIGH TIBIA PLATE

K100676 is the FDA 510(k) clearance for SYNTHES TOMOFIX(TM) MEIAL HIGH TIBIA PLATE by Synthes (Usa). It is a Class 2 Orthopedic device (product code HRS) cleared through the Special 510(k) pathway after a 29-day FDA review.

K100676 · Synthes (Usa) · Orthopedic device
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Apr 2010
Decision
29d
Days
Class 2
Risk

K100676 is an FDA 510(k) clearance for the SYNTHES TOMOFIX(TM) MEIAL HIGH TIBIA PLATE, SMALL. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Synthes (Usa) (West Chester, US). The FDA issued a Cleared decision on April 8, 2010 after a review of 29 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 Synthes (Usa) devices

Submission Details

510(k) Number K100676 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2010
Decision Date April 08, 2010
Days to Decision 29 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
93d faster than avg
Panel avg: 122d · This submission: 29d
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 902
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K100676.
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
SYNTHES 3.5MM QUADRILATERAL SURFACE PLATES
K093928 · Synthes (Usa) · Mar 2010
DEPUY FRACTURE AND FUSION PLATING SYSTEM
K093474 · DePuy Orthopaedics, Inc. · Feb 2010
EVOLVE EPS ORTHOLOC
K100146 · Wrightmedicaltechnologyinc · Feb 2010