Cleared Traditional

TAPER 2 POROUS FEMORAL STEM (K050441) - FDA 510(k) Clearance

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

K050441 · Biomet, Inc. · Orthopedic device
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Jun 2005
Decision
127d
Days
Class 2
Risk

K050441 is an FDA 510(k) clearance for the TAPER 2 POROUS FEMORAL STEM. Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (product code JDI), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on June 29, 2005 after a review of 127 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 Biomet, Inc. devices

Submission Details

510(k) Number K050441 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2005
Decision Date June 29, 2005
Days to Decision 127 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
5d slower than avg
Panel avg: 122d · This submission: 127d
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 K050441.
ANTHOLOGY HIP STEM
K052792 · Smith & Nephew, Inc. · Oct 2005
RINGLOC BI-POLAR ACETABULAR COMPONENT
K051569 · Biomet, Inc. · Sep 2005
TRABECULAR METAL REVISION SHELL LINERS
K051516 · Zimmer, Inc. · Jul 2005
RESTORATION MODULAR SYSTEM
K051363 · Howmedica Osteonics Corp. · Jun 2005
ACUMATCH 12/14 PRESS-FIT FEMORAL STEMS
K051335 · Exactech, Inc. · Jun 2005
NEXGEN COMPLETE KNEE SOLUTION DISTAL FEMORAL SPACERS
K050105 · Zimmer, Inc. · May 2005