Cleared Traditional

K063049 - SYNTHES (USA) MODULAR MINI FRAGMENT LCP SYSTEM

K063049 is an FDA 510(k) clearance for SYNTHES (USA) MODULAR MINI FRAGMENT LCP..., manufactured by Synthes (Usa). The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K063049 · Synthes (Usa) · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2006
Decision
75d
Days
Class 2
Risk

K063049 is an FDA 510(k) clearance for the SYNTHES (USA) MODULAR MINI FRAGMENT LCP 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) (West Chester, US). The FDA issued a Cleared decision on December 18, 2006 after a review of 75 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.

FDA 510(k) Submission Details - K063049

510(k) Number K063049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2006
Decision Date December 18, 2006
Days to Decision 75 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
47d faster than avg
Panel avg: 122d · This submission: 75d
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 1332
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K063049.
FLEXIGRIP STERNAL CLOSURE SYSTEM, MODEL FG0200 THROUGH FG0400 (NONE SIZES)
K063009 · Praesidia S.R.L. · Dec 2006
HUMERUS LOCKING PLATING SYSTEM
K063095 · Newclip Technics · Dec 2006
I.T.S. PELVIC RECONSTRUCTION SYSTEM
K063166 · I.T.S. Implantat-Technologie-Systeme GmbH · Dec 2006
LORENZ STERNAL CLOSURE SYSTEM
K063506 · Walter Lorenz Surgical, Inc. · Dec 2006
INTAI BONE PLATE AND BONE SCREW SYSTEM
K063020 · Intai Technology, Inc. · Dec 2006
ACUMED CONGRUENT BONE PLATE SYSTEM
K063460 · Acumed, LLC · Dec 2006
K063049 · SYNTHES (USA) MODULAR MINI FRAGMENT LCP SYSTEM
Download PDF FDA Summary Synthes (Usa)