Cleared Traditional

K041872 - ASCENT POROUS OPEN BOX PS COMPONENT/ASC...

K041872 is an FDA 510(k) clearance for ASCENT POROUS OPEN BOX PS COMPONENT/ASC..., manufactured by Biomet Manufacturing Corp. The device is a Class 2 Orthopedic device with product code MBH cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K041872 · Biomet Manufacturing Corp · Orthopedic device
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Sep 2004
Decision
61d
Days
Class 2
Risk

K041872 is an FDA 510(k) clearance for the ASCENT POROUS OPEN BOX PS COMPONENT/ASCENT POSTERIOR STABALIZED (PS) DISTAL F.... Classified as Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer (product code MBH), Class II - Special Controls.

Submitted by Biomet Manufacturing Corp (Warsaw, US). The FDA issued a Cleared decision on September 8, 2004 after a review of 61 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3565 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Biomet Manufacturing Corp devices

FDA 510(k) Submission Details - K041872

510(k) Number K041872 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2004
Decision Date September 08, 2004
Days to Decision 61 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
61d faster than avg
Panel avg: 122d · This submission: 61d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 125
Devices cleared under the same product code (MBH) and FDA review panel - the closest regulatory comparables to K041872.
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