Cleared Traditional

NEXGEN COMPLETE KNEE SOLUTION DISTAL FEMORAL SPACERS (K050105) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K050105 · Zimmer, Inc. · Orthopedic device
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May 2005
Decision
119d
Days
Class 2
Risk

K050105 is an FDA 510(k) clearance for the NEXGEN COMPLETE KNEE SOLUTION DISTAL FEMORAL SPACERS. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on May 17, 2005 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3350 - 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 Zimmer, Inc. devices

Submission Details

510(k) Number K050105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2005
Decision Date May 17, 2005
Days to Decision 119 days
Submission Type Traditional
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
3d faster than avg
Panel avg: 122d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3350
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 - JDI Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

All 279
Devices cleared under the same product code (JDI) and FDA review panel - the closest regulatory comparables to K050105.
TAPER 2 POROUS FEMORAL STEM
K050441 · Biomet, Inc. · Jun 2005
RESTORATION MODULAR SYSTEM
K051363 · Howmedica Osteonics Corp. · Jun 2005
ACUMATCH 12/14 PRESS-FIT FEMORAL STEMS
K051335 · Exactech, Inc. · Jun 2005
MODIFICATION TO: RESTORATION MODULAR SYSTEM
K050138 · Howmedica Osteonics Corp. · Mar 2005
DEPUY C-STEM AMT HIP PROSTHESIS
K042959 · DePuy Orthopaedics, Inc. · Dec 2004
IM TOTAL FEMUR
K033871 · Biomet, Inc. · Apr 2004