Cleared Special

K121727 - MOVATION KNEE SYSTEM (FDA 510(k) Clearance)

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K121727 · Encore Medical, L.P. · Orthopedic device
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Aug 2012
Decision
64d
Days
Class 2
Risk

K121727 is an FDA 510(k) clearance for the MOVATION KNEE SYSTEM. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer + Additive/metal/polymer + Additive (product code OIY), Class II - Special Controls.

Submitted by Encore Medical, L.P. (Austin, US). The FDA issued a Cleared decision on August 15, 2012 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3560 - 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 Encore Medical, L.P. devices

Submission Details

510(k) Number K121727 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2012
Decision Date August 15, 2012
Days to Decision 64 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
58d faster than avg
Panel avg: 122d · This submission: 64d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OIY Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer + Additive/metal/polymer + Additive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3560
Definition Indicated For: 1. Painful And Disabled Knee Joint Resulting From Osteoarthritis, Rheumatoid Arthritis, Traumatic Arthritis Where One Or More Compartments Are Involved. 2. Correction Of Varus, Valgus, Or Posttraumatic Deformity. 3. Correction Or Revision Of Unsuccessful Osteotomy, Arthrodesis, Or Failure Of Previous Joint Replacement Procedure. For Cemented Use.
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.