Cleared Traditional

K862534 - PAULUS TITANIUM MINI BONE PLATES & BONE...

K862534 is the FDA 510(k) clearance for PAULUS TITANIUM MINI BONE PLATES & BONE... by Walter Lorenz Surgical, Inc.. It is a Class 2 Dental device (product code JEY) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K862534 · Walter Lorenz Surgical, Inc. · Dental device
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Aug 1986
Decision
36d
Days
Class 2
Risk

K862534 is an FDA 510(k) clearance for the PAULUS TITANIUM MINI BONE PLATES & BONE SCREWS. 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 August 7, 1986 after a review of 36 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. 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 Walter Lorenz Surgical, Inc. devices

Submission Details

510(k) Number K862534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 02, 1986
Decision Date August 07, 1986
Days to Decision 36 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 127d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 156
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K862534.
STORZ CONTOURED ANATOMICAL PLATING INSTRUMENT
K873926 · Storz Instrument Co. · Feb 1988
DUMBACH TITANIUM MESH IMPLANT SYSTEM
K862532 · Walter Lorenz Surgical, Inc. · Sep 1986
MANUAL SURG. INSTRU. FOR PAULUS TITANIUM SYSTEM
K862505 · Walter Lorenz Surgical, Inc. · Aug 1986
MANUAL SURG. INSTRU. FOR STEINHAUSER BONE PLATE
K862533 · Walter Lorenz Surgical, Inc. · Aug 1986
STEINHAUSER TITANIUM MINI BONE PLATES & SCREWS
K862482 · Walter Lorenz Surgical, Inc. · Jul 1986
ACROMED NESTED BONE PLATE
K855224 · Buckman Co., Inc. · Feb 1986