Cleared Traditional

K193247 - LATITUDE EV™ Total Elbow Arthroplasty

K193247 is an FDA 510(k) clearance for LATITUDE EV Total Elbow Arthroplasty, manufactured by Tornier, Inc.. The device is a Class 2 Orthopedic device with product code JDB cleared through the Traditional 510(k) pathway after a 254-day FDA review.

K193247 · Tornier, Inc. · Orthopedic device
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Aug 2020
Decision
254d
Days
Class 2
Risk

K193247 is an FDA 510(k) clearance for the LATITUDE EV™ Total Elbow Arthroplasty. Classified as Prosthesis, Elbow, Semi-constrained, Cemented (product code JDB), Class II - Special Controls.

Submitted by Tornier, Inc. (Bloomington, US). The FDA issued a Cleared decision on August 5, 2020 after a review of 254 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3160 - 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 Tornier, Inc. devices

FDA 510(k) Submission Details - K193247

510(k) Number K193247 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2019
Decision Date August 05, 2020
Days to Decision 254 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
132d slower than avg
Panel avg: 122d · This submission: 254d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDB Device Classification - Class 2, Special Controls

Product Code JDB Prosthesis, Elbow, Semi-constrained, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3160
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 - JDB Prosthesis, Elbow, Semi-constrained, Cemented

All 25
Devices cleared under the same product code (JDB) and FDA review panel - the closest regulatory comparables to K193247.
TEMA Elbow system - Line extension
K222807 · Lima Corporate S.P.A. · Oct 2022
LATITUDE EV Total Elbow Arthroplasty
K182461 · Tornier, Inc. · Dec 2018
Latitude EV Total Elbow Arthroplasty
K171010 · Tornier, Inc. · Aug 2017
RHEAD RADIAL HEAD EXTENDED STEMS
K102180 · Small Bone Innovations, Inc. · Dec 2010
LATITUDE ELBOW PROSTHESIS
K100562 · Tornier, Inc. · Jun 2010
LATITUDE ELBOW PROTHESIS
K070787 · Tornier · Aug 2007