Cleared Traditional

K133811 - RESTORIS POROUS PARTIAL KNEE SYSTEM (FDA 510(k) Clearance)

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

K133811 · Mako Surgical Corp. · Orthopedic device
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Jul 2014
Decision
204d
Days
Class 2
Risk

K133811 is an FDA 510(k) clearance for the RESTORIS POROUS PARTIAL KNEE SYSTEM. Classified as Prosthesis, Knee, Femorotibial, Unicompartmental/unicondylar, Uncemented, Porous-coated, Metal/polymer (product code NJD), Class II - Special Controls.

Submitted by Mako Surgical Corp. (New York, US). The FDA issued a Cleared decision on July 8, 2014 after a review of 204 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3535 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Mako Surgical Corp. devices

Submission Details

510(k) Number K133811 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2013
Decision Date July 08, 2014
Days to Decision 204 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
82d slower than avg
Panel avg: 122d · This submission: 204d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NJD Prosthesis, Knee, Femorotibial, Unicompartmental/unicondylar, Uncemented, Porous-coated, Metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3535
Definition Intended To Replace Part Of A Knee Joint In Order To Relieve Pain And Restore Knee Function, For Indications Such As Uni-compartmental Osteoarthritis; Inflammatory Arthritis; Traumatic Arthritis; Varus, Valgus Or Flexion Deformities; And Revision Surgery.
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 - NJD Prosthesis, Knee, Femorotibial, Unicompartmental/unicondylar, Uncemented, Porous-coated, Metal/polymer

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