Cleared Traditional

Trident? Tritanium? PST? Acetabular Shells

K142606 · Mako Surgical Corp. · Orthopedic

Jan 2015

Decision

133d

Days

Class 2

Risk

About This 510(k) Submission

K142606 is an FDA 510(k) clearance for the Trident? Tritanium? PST? Acetabular Shells, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (Class II — Special Controls, product code LPH), submitted by Mako Surgical Corp. (Cedar Knolls, US). The FDA issued a Cleared decision on January 26, 2015, 133 days after receiving the submission on September 15, 2014. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3358.

Submission Details

510(k) Number	K142606 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 15, 2014
Decision Date	January 26, 2015
Days to Decision	133 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	LPH — Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3358