Cleared Special

K133039 - RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM

K133039 is an FDA 510(k) clearance for RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM, manufactured by Mako Surgical Corporation. The device is a Class 2 Orthopedic device with product code NPJ cleared through the Special 510(k) pathway after a 75-day FDA review.

K133039 · Mako Surgical Corporation · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2013
Decision
75d
Days
Class 2
Risk

K133039 is an FDA 510(k) clearance for the RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM. Classified as Prosthesis, Knee Patellofemorotibial, Partial, Semi-constrained, Cemented, Polymer/metal/polymer (product code NPJ), Class II - Special Controls.

Submitted by Mako Surgical Corporation (Fort Lauderdale, US). The FDA issued a Cleared decision on December 10, 2013 after a review of 75 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.

FDA 510(k) Submission Details - K133039

510(k) Number K133039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2013
Decision Date December 10, 2013
Days to Decision 75 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
47d faster than avg
Panel avg: 122d · This submission: 75d
Pathway characteristics
Modification to existing cleared device.

NPJ Device Classification - Class 2, Special Controls

Product Code NPJ Prosthesis, Knee Patellofemorotibial, Partial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3560
Definition The Device Is Intended To Replace The Medial Condyle And The Patellofemoral Compartment Of The Distal Femur With A Single Device. The Device Is Meant To Be Used With A Uni-compartmental Tibial Base And Insert And A Resurfacing Patella. The Device Is Intended To Be Used With Bone Cement.
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 - NPJ Prosthesis, Knee Patellofemorotibial, Partial, Semi-constrained, Cemented, Polymer/metal/polymer

All 11
Devices cleared under the same product code (NPJ) and FDA review panel - the closest regulatory comparables to K133039.
RESTORIS Multicompartmental Knee System
K150307 · Mako Surgical Corp. · Mar 2015
IDUO BICOMPARTMENTAL KNEE REPAIR SYSTEM
K093513 · Conformis, Inc. · Dec 2009
SMITH & NEPHEW, INC. JOURNEY SELECT KNEE SYSTEM
K093056 · Smith & Nephew, Inc. · Dec 2009
RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEM
K090763 · Mako Surgical Corporation · Jun 2009
DEPUY GCK FEMORAL AND TIBIAL COMPONENTS
K070849 · DePuy Orthopaedics, Inc. · Jun 2007
DEPUY GRADUATED COMPARTMENTAL KNEE (GCK)
K061648 · DePuy Orthopaedics, Inc. · Sep 2006
K133039 · RESTORIS MULTICOMPARTMENTAL KNEE SYSTEM
Download PDF FDA Summary Mako Surgical Corpora…