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Tema Elbow System

by Lima Corporate S.P.A. 510(k)

Active United States

510(k) K181362

Overview

The Tema Elbow System is a prosthesis, elbow, constrained, cemented, which is a type of orthopedic device. It is designed to replace or support the elbow joint. The device is classified as a class 2 device.

The Tema Elbow System is supplied with various registration numbers, including 1721676, 2245304, and 1818910. It has received FDA 510(k) clearance, with a review advisory committee of Orthopedic. The device is intended for use in orthopedic applications, and its storage and handling requirements are not specified. The Tema Elbow System is available in various sizes, but specific details are not provided.

AI-generated from registry data, 22 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

Recall ongoing. 1 ongoing FDA recall. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK181362 Date16 Feb 2019ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-1261-2023 FDA Class II initiated 25 Jan 2023

    Due to the incorrect component, that is not cleared to be marketed in the U.S., being included in its elbow prosthesis.

Specification

510(k)

510(k) Number
FDA Product Code
JDC
Device Class
Class II
Regulation
21 CFR Part 888.3150
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Other devices from Lima Corporate S.P.A.

See all devices from Lima Corporate S.P.A. →

Questions

  • What is the TEMA Elbow System used for?

    The TEMA Elbow System is used to replace or support the elbow joint in orthopedic applications.

  • Is the TEMA Elbow System supplied in different sizes?

    Yes, the TEMA Elbow System is available in various sizes, although specific details are not provided.

  • What is the regulatory status of the TEMA Elbow System?

    The TEMA Elbow System has received FDA 510(k) clearance, with a review advisory committee of Orthopedic.

  • What are the storage and handling requirements for the TEMA Elbow System?

    The storage and handling requirements for the TEMA Elbow System are not specified.