Cleared Special

K061384 - LORENZ PECTUS SUPPORT BAR, TITANIUM

Also marketed or referenced as:
LORENZ PECTUS SUPPORT BAR STABILIZER, TITANIUM

K061384 is an FDA 510(k) clearance for LORENZ PECTUS SUPPORT BAR, manufactured by Walter Lorenz Surgical, Inc.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Special 510(k) pathway after a 19-day FDA review.

K061384 · Walter Lorenz Surgical, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2006
Decision
19d
Days
Class 2
Risk

K061384 is an FDA 510(k) clearance for the LORENZ PECTUS SUPPORT BAR, TITANIUM. 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 June 6, 2006 after a review of 19 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

FDA 510(k) Submission Details - K061384

510(k) Number K061384 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2006
Decision Date June 06, 2006
Days to Decision 19 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
103d faster than avg
Panel avg: 122d · This submission: 19d
Pathway characteristics
Modification to existing cleared device.

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 1216
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K061384.
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
EBI OPTILOCK PERIARTICULAR PLATING SYSTEM
K061098 · Ebi, L.P. · May 2006
AXSOS PLUS LOCKING PLATE SYSTEM
K061012 · Howmedica Osteonics Corp. · May 2006
TTC PLATE
K060473 · New Deal, S.A. · May 2006