Cleared Traditional

K063009 - FLEXIGRIP STERNAL CLOSURE SYSTEM, MODEL FG0200 THROUGH FG0400 (NONE SIZES)

K063009 is an FDA 510(k) clearance for FLEXIGRIP STERNAL CLOSURE SYSTEM, manufactured by Praesidia S.R.L.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K063009 · Praesidia S.R.L. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2006
Decision
86d
Days
Class 2
Risk

K063009 is an FDA 510(k) clearance for the FLEXIGRIP STERNAL CLOSURE SYSTEM, MODEL FG0200 THROUGH FG0400 (NONE SIZES). Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Praesidia S.R.L. (Buffalo, US). The FDA issued a Cleared decision on December 27, 2006 after a review of 86 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 Praesidia S.R.L. devices

FDA 510(k) Submission Details - K063009

510(k) Number K063009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2006
Decision Date December 27, 2006
Days to Decision 86 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
36d faster than avg
Panel avg: 122d · This submission: 86d
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 1085
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K063009.
MODIFICATION TO TTC PLATES
K070160 · New Deal, S.A. · Feb 2007
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K070241 · New Deal, S.A. · Feb 2007
INION CPS/OTPS FREEDOMPLATE
K063410 · Inion , Ltd. · Jan 2007
HUMERUS LOCKING PLATING SYSTEM
K063095 · Newclip Technics · Dec 2006
SYNTHES (USA) MODULAR MINI FRAGMENT LCP SYSTEM
K063049 · Synthes (Usa) · Dec 2006
LORENZ STERNAL CLOSURE SYSTEM
K063506 · Walter Lorenz Surgical, Inc. · Dec 2006