Cleared Special

K041100 - NEXGEN POROUS, HA/TCP, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS

K041100 is an FDA 510(k) clearance for NEXGEN POROUS, manufactured by Zimmer, Inc.. The device is a Class 2 Orthopedic device with product code MBH cleared through the Special 510(k) pathway after a 185-day FDA review.

K041100 · Zimmer, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2004
Decision
185d
Days
Class 2
Risk

K041100 is an FDA 510(k) clearance for the NEXGEN POROUS, HA/TCP, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS. Classified as Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer (product code MBH), Class II - Special Controls.

Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on October 29, 2004 after a review of 185 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3565 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Zimmer, Inc. devices

FDA 510(k) Submission Details - K041100

510(k) Number K041100 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2004
Decision Date October 29, 2004
Days to Decision 185 days
Submission Type Special
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
63d slower than avg
Panel avg: 122d · This submission: 185d
Pathway characteristics
Modification to existing cleared device.

MBH Device Classification - Class 2, Special Controls

Product Code MBH Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3565
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 - MBH Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer

All 142
Devices cleared under the same product code (MBH) and FDA review panel - the closest regulatory comparables to K041100.
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