Cleared Traditional

K133811 - RESTORIS POROUS PARTIAL KNEE SYSTEM

K133811 is an FDA 510(k) clearance for RESTORIS POROUS PARTIAL KNEE SYSTEM, manufactured by Mako Surgical Corp.. The device is a Class 2 Orthopedic device with product code NJD cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K133811 · Mako Surgical Corp. · Orthopedic device
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Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K133811

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
Combination Product No
PCCP Authorized No
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.

NJD Device Classification - Class 2, Special Controls

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.