Cleared Traditional

LATITUDE EV Total Elbow Arthroplasty (K182461) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K182461 · Tornier, Inc. · Orthopedic device
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Dec 2018
Decision
108d
Days
Class 2
Risk

K182461 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 December 27, 2018 after a review of 108 days - within the typical 510(k) review window.

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

Submission Details

510(k) Number K182461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 10, 2018
Decision Date December 27, 2018
Days to Decision 108 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
14d faster than avg
Panel avg: 122d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 26
Devices cleared under the same product code (JDB) and FDA review panel - the closest regulatory comparables to K182461.
TEMA Elbow system - Line extension
K222807 · Lima Corporate S.P.A. · Oct 2022
LATITUDE EV™ Total Elbow Arthroplasty
K193247 · Tornier, Inc. · Aug 2020
CAPITELLO-CONDYLAR TOTAL ELBOW PROSTHESIS
K983141 · Johnson & Johnson Professionals, Inc. · Nov 1998
ABC TOTAL ELBOW PROTHESIS
K972691 · Biomet, Inc. · Oct 1997
SORIBIE RESURFACING TOTAL ELBOW SYSTEM (PROPOSED NAME)
K960087 · Wrightmedicaltechnologyinc · Sep 1996
SORBIE TOTAL ELBOW SYSTEM
K955099 · Wrightmedicaltechnologyinc · Feb 1996