Cleared Traditional

K063049 - SYNTHES (USA) MODULAR MINI FRAGMENT LCP...

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

K063049 · Synthes (Usa) · Orthopedic device
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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.

View all Synthes (Usa) devices

Submission Details

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.

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 K063049.
KLS MARTIN QUICK DISC, STERNAL TALON AND STERNAL PLATING - STERILE
K070169 · KLS-Martin L.P. · Mar 2007
STRYKER FOOT PLATING SYSTEM
K063875 · Howmedica Osteonics Corp. · Mar 2007
HUMERUS LOCKING PLATING SYSTEM
K063095 · Newclip Technics · Dec 2006
LORENZ STERNAL CLOSURE SYSTEM
K063506 · Walter Lorenz Surgical, Inc. · Dec 2006
ACUMED CONGRUENT BONE PLATE SYSTEM
K063460 · Acumed, LLC · Dec 2006
UNIVERSAL LOCKING SYSTEM, 2.7MM PLATES & SCREWS
K063303 · Zimmer, Inc. · Nov 2006