Cleared Abbreviated

K042515 - SMITH & NEPHEW

K042515 is the FDA 510(k) clearance for SMITH & NEPHEW by Smith & Nephew, Inc.. It is a Class 2 Orthopedic device (product code JWH) cleared through the Abbreviated 510(k) pathway after a 179-day FDA review.

K042515 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2005
Decision
179d
Days
Class 2
Risk

K042515 is an FDA 510(k) clearance for the SMITH & NEPHEW, INC. HIGH PERFORMANCE KNEE. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on March 14, 2005 after a review of 179 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Smith & Nephew, Inc. devices

Submission Details

510(k) Number K042515 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2004
Decision Date March 14, 2005
Days to Decision 179 days
Submission Type Abbreviated
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 122d · This submission: 179d
Pathway characteristics
Standards-based clearance path.

Device Classification

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 777
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K042515.
TRIATHLON KNEE SYSTEM
K051146 · Howmedica Osteonics Corp. · Jul 2005
MG II TOTAL KNEE SYSTEM STEMMED TIBIAL BASEPLATE COMPONENTS
K050723 · Zimmer, Inc. · Apr 2005
SIZE 1 TRIATHLON POSTERIOR STABILIZED (PS) TIBIAL INSERT
K050539 · Howmedica Osteonics Corp. · Mar 2005
SMITH & NEPHEW GENESIS II DEEP FLEXION CRUCIATE RETAINING ARTICULAR INSERT
K041825 · Smith & Nephew, Inc. · Mar 2005
NEXGEN COMPLETE KNEE SOLUTION MIS TIBIAL COMPONENTS, LOCKING SCREW AND STEM EXTENSIONS
K043101 · Zimmer, Inc. · Mar 2005
SMITH & NEPHEW, INC. REVISION KNEE SYSTEM
K043440 · Smith & Nephew, Inc. · Feb 2005