Cleared Abbreviated

K043083 - ADVANCE HA COATED SPIKED TIBIAL BASE AND ADVANCE HA COATED MODULAR KEEL

K043083 is an FDA 510(k) clearance for ADVANCE HA COATED SPIKED TIBIAL BASE AN..., manufactured by Wrightmedicaltechnologyinc. The device is a Class 2 Orthopedic device with product code MBH cleared through the Abbreviated 510(k) pathway after a 161-day FDA review.

K043083 · Wrightmedicaltechnologyinc · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2005
Decision
161d
Days
Class 2
Risk

K043083 is an FDA 510(k) clearance for the ADVANCE HA COATED SPIKED TIBIAL BASE AND ADVANCE HA COATED MODULAR KEEL. Classified as Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer (product code MBH), Class II - Special Controls.

Submitted by Wrightmedicaltechnologyinc (Arlington, US). The FDA issued a Cleared decision on April 18, 2005 after a review of 161 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Wrightmedicaltechnologyinc devices

FDA 510(k) Submission Details - K043083

510(k) Number K043083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2004
Decision Date April 18, 2005
Days to Decision 161 days
Submission Type Abbreviated
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
39d slower than avg
Panel avg: 122d · This submission: 161d
Pathway characteristics
Standards-based clearance path.

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 K043083.
TRABECULAR METAL TIBIAL AND FEMORAL CONE AUGMENTS
K053340 · Zimmer Trabecular · Feb 2006
TRIATHLON PRESS-FIT TOTAL KNEE SYSTEM
K051380 · Howmedica Osteonics Corp. · Aug 2005
VANGUARD ANTERIOR STABILIZED TIBIAL BEARINGS
K050222 · Biomet, Inc. · Aug 2005
DURACON CONVERSION AND X-SMALL SYMMETRIC PATELLA WITH PERI-APATITE COATING
K043374 · Howmedica Osteonics Corp. · Feb 2005
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