Cleared Traditional

K081353 - SYNTHES (USA) TOMOFIX MEDIAL DISTAL FEM...

K081353 is the FDA 510(k) clearance for SYNTHES (USA) TOMOFIX MEDIAL DISTAL FEM... by Synthes (Usa). It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K081353 · Synthes (Usa) · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jul 2008
Decision
70d
Days
Class 2
Risk

K081353 is an FDA 510(k) clearance for the SYNTHES (USA) TOMOFIX MEDIAL DISTAL FEMUR PLATES. 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 July 23, 2008 after a review of 70 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) devices

Submission Details

510(k) Number K081353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2008
Decision Date July 23, 2008
Days to Decision 70 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
52d faster than avg
Panel avg: 122d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K081353.
CHARLOTTE LISFRANC BONE SCREW, CHARLOTTE LISFRANC PLATE
K081374 · Wrightmedicaltechnologyinc · Sep 2008
SYNTHES RIB FIXATION SYSTEM
K081623 · Synthes (Usa) · Sep 2008
SMALL BONE LOCKING PLATING SYSTEM
K081546 · DePuy Orthopaedics, Inc. · Aug 2008
ORTHOPEDIATRICS PEDIPLATES SYSTEM
K081407 · OrthoPediatrics Corp. · Jul 2008
ORTHOMESH
K073115 · Synthes (Usa) · Jul 2008
EVOLVE EPS SYSTEM
K081373 · Wrightmedicaltechnologyinc · Jul 2008