Cleared Special

K063506 - LORENZ STERNAL CLOSURE SYSTEM

K063506 is the FDA 510(k) clearance for LORENZ STERNAL CLOSURE SYSTEM by Walter Lorenz Surgical, Inc.. It is a Class 2 Orthopedic device (product code HRS) cleared through the Special 510(k) pathway after a 28-day FDA review.

K063506 · Walter Lorenz Surgical, Inc. · Orthopedic device
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Dec 2006
Decision
28d
Days
Class 2
Risk

K063506 is an FDA 510(k) clearance for the LORENZ 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 Walter Lorenz Surgical, Inc. (Jacksonville, US). The FDA issued a Cleared decision on December 18, 2006 after a review of 28 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Walter Lorenz Surgical, Inc. devices

Submission Details

510(k) Number K063506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 20, 2006
Decision Date December 18, 2006
Days to Decision 28 days
Submission Type Special
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
94d faster than avg
Panel avg: 122d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 897
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K063506.
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
SYNTHES (USA) MODULAR MINI FRAGMENT LCP SYSTEM
K063049 · Synthes (Usa) · Dec 2006
ACUMED CONGRUENT BONE PLATE SYSTEM
K063460 · Acumed, LLC · Dec 2006
UNIVERSAL LOCKING SYSTEM, 2.7MM PLATES & SCREWS
K063303 · Zimmer, Inc. · Nov 2006
PROFYLE SYSTEM
K062498 · Howmedica Osteonics Corp. · Oct 2006