Cleared Traditional

K081400 - FANNING-PAPPAS MODULAR KNEE BEARING

K081400 is an FDA 510(k) clearance for FANNING-PAPPAS MODULAR KNEE BEARING, manufactured by Endotec, Inc.. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 277-day FDA review.

K081400 · Endotec, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2009
Decision
277d
Days
Class 2
Risk

K081400 is an FDA 510(k) clearance for the FANNING-PAPPAS MODULAR KNEE BEARING. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Endotec, Inc. (Orlando, US). The FDA issued a Cleared decision on February 20, 2009 after a review of 277 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3560 - the FDA orthopedic 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 Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Endotec, Inc. devices

FDA 510(k) Submission Details - K081400

510(k) Number K081400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2008
Decision Date February 20, 2009
Days to Decision 277 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
155d slower than avg
Panel avg: 122d · This submission: 277d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JWH Device Classification - Class 2, Special Controls

Product Code JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3560
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 Orthopedic devices follow this clearance model.

Regulatory Peers - JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

All 849
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K081400.
GMK TOTAL KNEE SYSTEM
K090988 · Medacta International S.A. · Jul 2009
COLUMBUS REVISION KNEE SYSTEM
K083772 · Aesculap Implant System, Inc. · Jun 2009
FREEDOM METAL BACKED TIBIAL COMPONENT
K090411 · Maxx Orthopedics, Inc. · Apr 2009
FREEDOM TOTAL KNEE SYSTEM
K082019 · Maxx Orthopedics, Inc. · Feb 2009
UNITED U2 TOTAL KNEE SYSTEM
K082424 · United Orthopedic Corp. · Dec 2008
SMITH & NEPHEW, INC. PATIENT MATCHED TECHNOLOGY
K082358 · Smith & Nephew, Inc. · Nov 2008