Cleared Traditional

K032905 - 3DKNEE POROUS COATED FEMORAL COMPONENT

K032905 is an FDA 510(k) clearance for 3DKNEE POROUS COATED FEMORAL COMPONENT, manufactured by Encore Orthopedics, Inc.. The device is a Class 2 Orthopedic device with product code MBH cleared through the Traditional 510(k) pathway after a 293-day FDA review.

K032905 · Encore Orthopedics, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2004
Decision
293d
Days
Class 2
Risk

K032905 is an FDA 510(k) clearance for the 3DKNEE POROUS COATED FEMORAL COMPONENT. Classified as Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer (product code MBH), Class II - Special Controls.

Submitted by Encore Orthopedics, Inc. (Austin, US). The FDA issued a Cleared decision on July 6, 2004 after a review of 293 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. 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 Encore Orthopedics, Inc. devices

FDA 510(k) Submission Details - K032905

510(k) Number K032905 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2003
Decision Date July 06, 2004
Days to Decision 293 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
171d slower than avg
Panel avg: 122d · This submission: 293d
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 K032905.
TRABECULAR METAL KNEE SYSTEM AUGMENTS
K040487 · Implex Corp. · Dec 2004
NEXGEN POROUS, HA/TCP, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS
K041100 · Zimmer, Inc. · Oct 2004
ASCENT POROUS OPEN BOX PS COMPONENT/ASCENT POSTERIOR STABALIZED (PS) DISTAL FEMORAL PEGS
K041872 · Biomet Manufacturing Corp · Sep 2004
AGC TOTAL KNEE SYSTEM KNEE, ASCENT TOTAL KNEE SYSTEM, MAXIM COMPLETE KNEE SYSTEM, MAXIM ACCEL KNEE SYSTEM ALSO KNOWN
K033489 · Biomet, Inc. · Jun 2004
SCORPIO TOTAL KNEE SYSTEM WITH PERI-APATITE COATING
K033971 · Howmedica Osteonics Corp. · May 2004
SCORPIO TOTAL KNEE SYSTEM
K033972 · Howmedica Osteonics Corp. · Apr 2004