Cleared Special

K001238 - LORENZ TITANIUM FRACTURE / RECONSTRUCTION PLATING SYSTEM

K001238 is an FDA 510(k) clearance for LORENZ TITANIUM FRACTURE / RECONSTRUCTI..., manufactured by Walter Lorenz Surgical, Inc.. The device is a Class 2 Dental device with product code JEY cleared through the Special 510(k) pathway after a 15-day FDA review.

K001238 · Walter Lorenz Surgical, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2000
Decision
15d
Days
Class 2
Risk

K001238 is an FDA 510(k) clearance for the LORENZ TITANIUM FRACTURE / RECONSTRUCTION PLATING SYSTEM. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Walter Lorenz Surgical, Inc. (Jacksonville, US). The FDA issued a Cleared decision on May 3, 2000 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4760 - the FDA dental 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 - K001238

510(k) Number K001238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2000
Decision Date May 03, 2000
Days to Decision 15 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 127d · This submission: 15d
Pathway characteristics
Modification to existing cleared device.

JEY Device Classification - Class 2, Special Controls

Product Code JEY Plate, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4760
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 Dental devices follow this clearance model.

Regulatory Peers - JEY Plate, Bone

All 249
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K001238.
CODMAN CRANIOSORB ABSORBABLE FIXATION SYSTEM
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BIOSORBPDX BIOABSORBABLE FIXATION SYSTEM
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K993862 · The Straumann Co. · Dec 1999
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K992682 · Medartis AG · Nov 1999