Cleared Traditional

K141796 - DEPUY SYNTHES TOMOFIX OSTEOTOMY SYSTEM

K141796 is an FDA 510(k) clearance for DEPUY SYNTHES TOMOFIX OSTEOTOMY SYSTEM, manufactured by Synthes USA Products, LLC. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K141796 · Synthes USA Products, LLC · Orthopedic device
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Aug 2014
Decision
57d
Days
Class 2
Risk

K141796 is an FDA 510(k) clearance for the DEPUY SYNTHES TOMOFIX OSTEOTOMY 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 Synthes USA Products, LLC (West Chester, US). The FDA issued a Cleared decision on August 29, 2014 after a review of 57 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Synthes USA Products, LLC devices

FDA 510(k) Submission Details - K141796

510(k) Number K141796 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2014
Decision Date August 29, 2014
Days to Decision 57 days
Submission Type Traditional
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
65d faster than avg
Panel avg: 122d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 1242
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K141796.
PRO-LINK WEDGE SYSTEM
K141905 · Life Spine · Sep 2014
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K142418 · I.T.S. GmbH · Sep 2014
Flower Upper Extremity Plating Set
K142306 · Flower Orthopedics Corporation · Sep 2014
DISTAL ELBOW PLATING SYSTEM
K140892 · Skeletal Dynamics, LLC · Aug 2014
REDUCE FRACTURE PLATING SYSTEM LINE EXTENSION
K142135 · Icon Orthopedic Concepts, LLC Dba Edge Orthopaedic · Aug 2014
VALOR HINDFOOT FUSION NAIL SYSTEM
K142121 · Wrightmedicaltechnologyinc · Aug 2014