LATITUDE EV Total Elbow Arthroplasty
FDA 510(k) K182461 · Tornier, Inc.
510(k) numberK182461
Submission
- Device name
- LATITUDE EV Total Elbow Arthroplasty
- Applicant
- Tornier, Inc.
Bloomington, MN, US - Received
- September 10, 2018
- Decision date
- December 27, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JDB – Prosthesis, Elbow, Semi-Constrained, Cemented
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3160
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code JDB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K222807 | TEMA Elbow system - Line extensionJDB · Traditional | Lima Corporate S.P.A. | 10/26/2022SE |
| K193247 | LATITUDE EV Total Elbow ArthroplastyJDB · Traditional | Tornier, Inc. | 08/05/2020SE |
| K171010 | Latitude EV Total Elbow ArthroplastyJDB · Traditional | Tornier, Inc. | 08/31/2017SE |
| K102180 | Rhead Radial Head Extended StemsJDB · Traditional | Small Bone Innovations, Inc. | 12/20/2010SE |
| K100562 | Latitude Elbow ProsthesisJDB · Special | Tornier, Inc. | 06/29/2010SE |
| K070787 | Latitude Elbow ProthesisJDB · Special | Tornier | 08/24/2007SE |
| K070236 | Sbi Lateral Radio CapitellumJDB · Special | Small Bone Innovations, Inc. | 02/21/2007SE |
| K060438 | RHSJDB · Traditional | Tornier | 04/18/2006SE |
| K060038 | Sbi Radio-Capitellar ImplantJDB · Traditional | Small Bone Innovations, Inc. | 03/30/2006SE |
| K050848 | Tornier Elbow ProsthesisJDB · Traditional | Tornier | 07/14/2005SE |
More from Tornier
| 510(k) | Device | Decision |
|---|---|---|
| K260721 | Tornier Perform Advanced GlenoidKWS · Traditional | 07/22/2026SE |
| K252788 | Tornier Perform Reversed Monopost Glenoid (Perform Mono)PHX · Traditional | 01/08/2026SE |
| K251686 | Tornier Humeral Reconstruction System Max (Tornier HRS Max)KWT · Traditional | 10/30/2025SE |
| K230352 | Tornier Humeral Nail and Tornier Long Humeral NailHSB · Traditional | 10/31/2023SE |
| K220914 | Tornier Perform Humeral System FracturePHX · Traditional | 10/14/2022SE |
| K220418 | Tornier Perform Humeral System StemlessPKC · Traditional | 09/14/2022SE |
| K211359 | Tornier Perform Patient-Matched Primary Reversed Glenoid and BLUEPRINT Patient…PHX · Traditional | 11/12/2021SE |
| K213124 | Tomier Perform Reversed Glenoid Cannulated GlenospheresPHX · Special | 10/26/2021SE |
| K201315 | PERFORM Humeral System StemPAO · Traditional | 09/11/2020SE |
| K193247 | LATITUDE EV Total Elbow ArthroplastyJDB · Traditional | 08/05/2020SE |
Questions and answers
When was LATITUDE EV Total Elbow Arthroplasty cleared by the FDA?
LATITUDE EV Total Elbow Arthroplasty (K182461) received a 510(k) decision of Substantially Equivalent on December 27, 2018, 108 days after the submission was received.
What is the product code of K182461?
The FDA product code is JDB – Prosthesis, Elbow, Semi-Constrained, Cemented, a Class II (moderate risk) device regulated under 21 CFR 888.3160.