Cleared Traditional

K060177 - KLS MARTIN RIGID FIXATION - STERILE

K060177 is the FDA 510(k) clearance for KLS MARTIN RIGID FIXATION - STERILE by KLS-Martin L.P.. It is a Class 2 Dental device (product code JEY) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K060177 · KLS-Martin L.P. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2006
Decision
85d
Days
Class 2
Risk

K060177 is an FDA 510(k) clearance for the KLS MARTIN RIGID FIXATION - STERILE. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by KLS-Martin L.P. (Jacksonville, US). The FDA issued a Cleared decision on April 18, 2006 after a review of 85 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 KLS-Martin L.P. devices

Submission Details

510(k) Number K060177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2006
Decision Date April 18, 2006
Days to Decision 85 days
Submission Type Traditional
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
42d faster than avg
Panel avg: 127d · This submission: 85d
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 K060177.
SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEM
K062789 · Synthes (Usa) · Feb 2007
LORENZ TITANIUM FRACTURE / RECONSTRUCTION DEVICES AND PRE-BENT PLATES
K063052 · Walter Lorenz Surgical, Inc. · Jan 2007
SONICWELD RX ENDOBROW FIXATION
K061507 · KLS-Martin L.P. · Sep 2006
AESCULAP CRANIOFACIAL PLATE AND SCREW
K060492 · Aesculap, Inc. · Apr 2006
RESORB-X SF
K051236 · KLS-Martin L.P. · Aug 2005
JEIL BONE FIXATION SYSTEM
K050669 · Jeil Medical Corporation · May 2005