Cleared Traditional

KLS Martin Individual Patient Solutions (IPS) Planning System

K192979 · KLS-Martin L.P. · Orthopedic

Mar 2020

Decision

139d

Days

Class 2

Risk

About This 510(k) Submission

K192979 is an FDA 510(k) clearance for the KLS Martin Individual Patient Solutions (IPS) Planning System, a Orthopaedic Surgical Planning And Instrument Guides (Class II — Special Controls, product code PBF), submitted by KLS-Martin L.P. (Jacksonville, US). The FDA issued a Cleared decision on March 11, 2020, 139 days after receiving the submission on October 24, 2019. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K192979 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 24, 2019
Decision Date	March 11, 2020
Days to Decision	139 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	PBF — Orthopaedic Surgical Planning And Instrument Guides
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3030
Definition	As A Surgical Instrument To Assist In Pre-operative Planning And/or Guiding The Marking Of Bone And/or Guide Surgical Instruments For Orthopedic Surgical Procedures.