Cleared Traditional

K120038 - A200 KNEE SYSTEM (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K120038 · Renovis Surgical Technologies, LLC · Orthopedic device
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Feb 2013
Decision
406d
Days
Class 2
Risk

K120038 is an FDA 510(k) clearance for the A200 KNEE SYSTEM. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer + Additive/metal/polymer + Additive (product code OIY), Class II - Special Controls.

Submitted by Renovis Surgical Technologies, LLC (San Diego, US). The FDA issued a Cleared decision on February 14, 2013 after a review of 406 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3560 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all Renovis Surgical Technologies, LLC devices

Submission Details

510(k) Number K120038 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 2012
Decision Date February 14, 2013
Days to Decision 406 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
284d slower than avg
Panel avg: 122d · This submission: 406d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.