Cleared Traditional

K143752 - Total Knee Application (TKA)

K143752 is an FDA 510(k) clearance for Total Knee Application (TKA), manufactured by Mako Surgical Corp.. The device is a Class 2 Orthopedic device with product code OLO cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K143752 · Mako Surgical Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2015
Decision
218d
Days
Class 2
Risk

K143752 is an FDA 510(k) clearance for the Total Knee Application (TKA). Classified as Orthopedic Stereotaxic Instrument within the OLO classification (a category covering orthopedic stereotaxic and surgical navigation instruments), Class II - Special Controls.

Submitted by Mako Surgical Corp. (Fort Lauderdale, US). The FDA issued a Cleared decision on August 6, 2015 after a review of 218 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 882.4560 - 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 - K143752

510(k) Number K143752 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2014
Decision Date August 06, 2015
Days to Decision 218 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
96d slower than avg
Panel avg: 122d · This submission: 218d
Pathway characteristics
Predicate-based equivalence.

OLO Device Classification - Class 2, Special Controls

Product Code OLO Orthopedic Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
Definition Stereotaxic Guidance During Orthopedic Surgery Procedures. Indicated For Orthopedic Joint Or Spine Surgery. Neurological Stereotaxic Instruments Are Classified Under Product Code Haw.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Orthopedic devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT02058069 Completed Interventional Industry-sponsored

Robotic Arm Assisted Total Knee Arthroplasty

100
Patients (actual)
3
Sites
Treatment
Purpose
Open label
Masking
Condition studied Osteoarthritis; Rheumatoid Arthritis; Post-traumatic Arthritis
Study design Single group
Eligibility All sexes · 21 Years+
Principal investigator Kenneth Gustke, MD
Sponsor MAKO Surgical Corp. (industry)
Started 2014-02-01 → Primary completion 2015-01-01
Primary outcome
Intra-Operative Complications
Secondary outcome
Change in the Radiographic Assessment of Limb Alignment From Pre-Operative to 3 Months Post-Operative
View full study on ClinicalTrials.gov

Regulatory Peers - OLO Orthopedic Stereotaxic Instrument

All 433
Devices cleared under the same product code (OLO) and FDA review panel - the closest regulatory comparables to K143752.
Navio
K152574 · Blue Belt Technologies, Inc. · Oct 2015
Partial Knee Application (PKA)
K142530 · Mako Surgical Corporation · Sep 2015
Navigated XIA 4.5 Polyaxial Screwdriver
K143597 · Stryker Corporate · Sep 2015
Navigated Disc Prep Instruments and CAPSTONE Trials
K150231 · Medtronic Sofamor Danek USA, Inc. · Jun 2015
Navio
K143668 · Blue Belt Technologies, Inc. · Mar 2015
AESCULAP ORTHOPILOT NEXT GENERATION
K141694 · Aesculap Implant Systems, LLC · Feb 2015