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FDA 510(k)

LATITUDE EV Total Elbow Arthroplasty

K-Number: K182461 · 2018-12-27

ApplicantTornier, Inc.
Decision Date2018-12-27
Product CodeJDB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LATITUDE EV Total Elbow Arthroplasty is a medical device manufactured by Tornier, Inc.. It received FDA 510(k) clearance on 2018-12-27 under approval number K182461. The device is classified under product code JDB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LATITUDE EV Total Elbow Arthroplasty?

LATITUDE EV Total Elbow Arthroplasty is a medical device that received FDA 510(k) clearance on 2018-12-27. It is manufactured by Tornier, Inc.. The 510(k) number is K182461.

When was LATITUDE EV Total Elbow Arthroplasty approved by the FDA?

LATITUDE EV Total Elbow Arthroplasty received FDA 510(k) clearance on 2018-12-27, under approval number K182461.

What company makes LATITUDE EV Total Elbow Arthroplasty?

LATITUDE EV Total Elbow Arthroplasty is manufactured by Tornier, Inc..

What is the FDA product code for LATITUDE EV Total Elbow Arthroplasty?

The FDA product code for LATITUDE EV Total Elbow Arthroplasty is JDB.

Related Clinical Trials

NCT07191067 Pivotal Study on the NOVABLOC System for Patients Undergoing Primary Total Knee Arthroplasty RECRUITING NCT07613203 Forced-Air Warming for Preventing Perioperative Hypothermia During Total Knee Arthroplasty COMPLETED NCT07615972 Efficacy of a Roller Device Facilitating Self-massage in the Treatment of Chronic Lateral Epicondylitis NOT_YET_RECRUITING NCT06019832 Analysis of Varus Collapse in Obese Patients With Stem and Non-Stem Tibial Components Following Primary Total Knee Arthroplasty ACTIVE_NOT_RECRUITING NCT05543941 Evaluating XPERIENCE™ Advanced Surgical Irrigation RECRUITING NCT07611526 Investigation of the Individual Fatigue Response During Blood Flow Restriction Training NOT_YET_RECRUITING

Related PubMed Literature

PMID: 41209898 Evaluation of a Single Knee System: All-Polyethylene Tibia (APT) vs. Metal-Backed Tibia (MBT) in Primary Total Knee Arthroplasty. Cureus (2025) PMID: 32944459 Recall Rates of Total Knee Arthroplasty Devices Are Dependent on the FDA Approval Process. Cureus (2020) PMID: 29258356 Grave fraudulence in medical device research: a narrative review of the PIN seeding study for the Pinnacle hip system. Accountability in research (2018)

Other Devices by Tornier, Inc.

K161742Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid K160975Aequalis PerFORM+ Shoulder System K171010Latitude EV Total Elbow Arthroplasty K181587ORTHOLOC SPS Shoulder Plating System K181420Aequalis Flex Revive Shoulder System K191711ORTHOLOC™ SPS Shoulder Plating System

View all 18 devices →

Related Devices (Code: JDB)

K171010Latitude EV Total Elbow ArthroplastyTornier, Inc. K193247LATITUDE EV™ Total Elbow ArthroplastyTornier, Inc. K222807TEMA Elbow system - Line extensionLima Corporate S.P.A.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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