Cleared Traditional

K063181 - SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM

K063181 is the FDA 510(k) clearance for SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM by Synthes (Usa). It is a Class 2 Dental device (product code NEI) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K063181 · Synthes (Usa) · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2007
Decision
78d
Days
Class 2
Risk

K063181 is an FDA 510(k) clearance for the SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM. Classified as Prosthesis, Condyle, Mandibular, Temporary (product code NEI), Class II - Special Controls.

Submitted by Synthes (Usa) (West Chester, US). The FDA issued a Cleared decision on January 5, 2007 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4770 - 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 Synthes (Usa) devices

Submission Details

510(k) Number K063181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2006
Decision Date January 05, 2007
Days to Decision 78 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
49d faster than avg
Panel avg: 127d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NEI Prosthesis, Condyle, Mandibular, Temporary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4770
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 - NEI Prosthesis, Condyle, Mandibular, Temporary

Devices cleared under the same product code (NEI) and FDA review panel - the closest regulatory comparables to K063181.
STRYKER TEMPORARY CONDYLAR PROSTHESIS
K133285 · Stryker · Apr 2014
MODIFICATION TO SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM
K081747 · Synthes (Usa) · Sep 2008
ADD-ON CONDYLE
K002790 · Walter Lorenz Surgical, Inc. · Aug 2001
KLS-MARTIN TEMPORARY CONDYLAR IMPLANT
K990667 · KLS-Martin L.P. · Jul 2001
SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEAD
K990637 · Synthes (Usa) · Oct 1999