Cleared Traditional

K050105 - NEXGEN COMPLETE KNEE SOLUTION DISTAL FEMORAL SPACERS

K050105 is an FDA 510(k) clearance for NEXGEN COMPLETE KNEE SOLUTION DISTAL FE..., manufactured by Zimmer, Inc.. The device is a Class 2 Orthopedic device with product code JDI cleared through the Traditional 510(k) pathway after a 119-day FDA review.

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

FDA 510(k) Submission Details - K050105

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.

JDI Device Classification - Class 2, Special Controls

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 516
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