Cleared Traditional

K093772 - SYNTHES STERNAL FIXATION SYSTEM

K093772 is the FDA 510(k) clearance for SYNTHES STERNAL FIXATION SYSTEM by Synthes. It is a Class 2 Orthopedic device (product code HRS) cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K093772 · Synthes · Orthopedic device
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Mar 2010
Decision
111d
Days
Class 2
Risk

K093772 is an FDA 510(k) clearance for the SYNTHES STERNAL FIXATION 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 (West Chester, US). The FDA issued a Cleared decision on March 29, 2010 after a review of 111 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Synthes devices

Submission Details

510(k) Number K093772 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2009
Decision Date March 29, 2010
Days to Decision 111 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 122d · This submission: 111d
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 904
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K093772.
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 TOMOFIX(TM) MEIAL HIGH TIBIA PLATE, SMALL
K100676 · Synthes (Usa) · 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