Cleared Special

K120531 - VERSAFITCUP CC TRIO-ADDITIONAL LINERS

K120531 is the FDA 510(k) clearance for VERSAFITCUP CC TRIO-ADDITIONAL LINERS by Medacta International. It is a Class 2 Orthopedic device (product code LZO) cleared through the Special 510(k) pathway after a 56-day FDA review.

K120531 · Medacta International · Orthopedic device
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Apr 2012
Decision
56d
Days
Class 2
Risk

K120531 is an FDA 510(k) clearance for the VERSAFITCUP CC TRIO-ADDITIONAL LINERS. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by Medacta International (Camarillo, US). The FDA issued a Cleared decision on April 18, 2012 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medacta International devices

Submission Details

510(k) Number K120531 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 22, 2012
Decision Date April 18, 2012
Days to Decision 56 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
66d faster than avg
Panel avg: 122d · This submission: 56d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
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 - LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

All 435
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