Cleared Special

K122218 - ADVANCE TOTAL KNEE SYSTEM-PATELLA

K122218 is an FDA 510(k) clearance for ADVANCE TOTAL KNEE SYSTEM-PATELLA, manufactured by Wrightmedicaltechnologyinc. The device is a Class 2 Orthopedic device with product code MBH cleared through the Special 510(k) pathway after a 239-day FDA review.

K122218 · Wrightmedicaltechnologyinc · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2013
Decision
239d
Days
Class 2
Risk

K122218 is an FDA 510(k) clearance for the ADVANCE TOTAL KNEE SYSTEM-PATELLA. 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 March 21, 2013 after a review of 239 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.

FDA 510(k) Submission Details - K122218

510(k) Number K122218 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2012
Decision Date March 21, 2013
Days to Decision 239 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
117d slower than avg
Panel avg: 122d · This submission: 239d
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

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Download PDF FDA Summary Wrightmedicaltechnolo…