Cleared Traditional

K133285 - STRYKER TEMPORARY CONDYLAR PROSTHESIS

K133285 is an FDA 510(k) clearance for STRYKER TEMPORARY CONDYLAR PROSTHESIS, manufactured by Stryker. The device is a Class 2 Dental device with product code NEI cleared through the Traditional 510(k) pathway after a 166-day FDA review.

K133285 · Stryker · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2014
Decision
166d
Days
Class 2
Risk

K133285 is an FDA 510(k) clearance for the STRYKER TEMPORARY CONDYLAR PROSTHESIS. Classified as Prosthesis, Condyle, Mandibular, Temporary (product code NEI), Class II - Special Controls.

Submitted by Stryker (Portage, US). The FDA issued a Cleared decision on April 9, 2014 after a review of 166 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Stryker devices

FDA 510(k) Submission Details - K133285

510(k) Number K133285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 2013
Decision Date April 09, 2014
Days to Decision 166 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
39d slower than avg
Panel avg: 127d · This submission: 166d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NEI Device Classification - Class 2, Special Controls

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 K133285.
MODIFICATION TO SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM
K081747 · Synthes (Usa) · Sep 2008
SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM
K063181 · Synthes (Usa) · Jan 2007
OSTEOMED TEMPORARY CONDYLAR ATTACHMENT SYSTEM
K031701 · Osteomed LP · Jul 2004
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