Cleared Traditional

K053624 - MEDICON STERN-A-FIX STERNAL CLOSURE SYSTEM

K053624 is an FDA 510(k) clearance for MEDICON STERN-A-FIX STERNAL CLOSURE SYSTEM, manufactured by Medicon EG. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 201-day FDA review.

K053624 · Medicon EG · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
201d
Days
Class 2
Risk

K053624 is an FDA 510(k) clearance for the MEDICON STERN-A-FIX STERNAL CLOSURE 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 Medicon EG (Amsterdam, Nh, NL). The FDA issued a Cleared decision on July 17, 2006 after a review of 201 days - an extended review 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: 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 Medicon EG devices

FDA 510(k) Submission Details - K053624

510(k) Number K053624 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2005
Decision Date July 17, 2006
Days to Decision 201 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
79d slower than avg
Panel avg: 122d · This submission: 201d
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 1043
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K053624.
DISTAL RADIUS LOCKING PLATING SYSTEM
K061917 · Newclip Technics · Aug 2006
SYNTHES (USA) CLAVICLE HOOK PLATES
K061753 · Synthes (Usa) · Aug 2006
LISFRANC PLATE
K060474 · New Deal, S.A. · Aug 2006
CALCANEAL TRAUMA SYSTEM
K061400 · Orthohelix Surgical Designs, Inc. · Jun 2006
NCB PLATING SYSTEM, PROXIMAL TIBIA PLATES
K061211 · Zimmer GmbH · Jun 2006
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM FOR THE UPPER EXTREMITY
K061352 · Smith & Nephew, Inc. · Jun 2006