Cleared Traditional

K031804 - COMPRESS DISTAL FEMORAL REPLACEMENT

K031804 is an FDA 510(k) clearance for COMPRESS DISTAL FEMORAL REPLACEMENT, manufactured by Biomet, Inc.. The device is a Class 2 Orthopedic device with product code KRO cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K031804 · Biomet, Inc. · Orthopedic device
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Dec 2003
Decision
190d
Days
Class 2
Risk

K031804 is an FDA 510(k) clearance for the COMPRESS DISTAL FEMORAL REPLACEMENT. Classified as Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer (product code KRO), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on December 18, 2003 after a review of 190 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3510 - 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

FDA 510(k) Submission Details - K031804

510(k) Number K031804 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2003
Decision Date December 18, 2003
Days to Decision 190 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
68d slower than avg
Panel avg: 122d · This submission: 190d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KRO Device Classification - Class 2, Special Controls

Product Code KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3510
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 - KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer

All 71
Devices cleared under the same product code (KRO) and FDA review panel - the closest regulatory comparables to K031804.
AVL HINGE KNEE SYSTEM
K051570 · Biomet, Inc. · Aug 2005
COMPRESS DISTAL FEMORAL REPLACEMENT SYSTEM
K041352 · Biomet, Inc. · Jul 2004
MODULAR REPLACEMENT SYSTEM CEMENTED STEMS
K040749 · Howmedica Osteonics Corp. · Jun 2004
GLOBAL MODULAR REPLACEMENT SYSTEM PEDIATRIC TIBIAL BEARING COMPONENT
K031480 · Howmedica Osteonics Corp. · Jul 2003
RT-PLUS SOLUTION & RT-PLUS MODULAR SOLUTION KNEE
K023667 · Plus Orthopedics · Dec 2002
GLOBAL MODULAR REPLACEMENT SYSTEM (GMRS)
K023087 · Howmedica Osteonics Corp. · Dec 2002