Cleared Traditional

K181362 - TEMA Elbow System

K181362 is an FDA 510(k) clearance for TEMA Elbow System, manufactured by Lima Corporate S.P.A.. The device is a Class 2 Orthopedic device with product code JDC cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K181362 · Lima Corporate S.P.A. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2019
Decision
269d
Days
Class 2
Risk

K181362 is an FDA 510(k) clearance for the TEMA Elbow System. Classified as Prosthesis, Elbow, Constrained, Cemented (product code JDC), Class II - Special Controls.

Submitted by Lima Corporate S.P.A. (Villanova Di San Daniele Del Friuli, IT). The FDA issued a Cleared decision on February 16, 2019 after a review of 269 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3150 - 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 Lima Corporate S.P.A. devices

FDA 510(k) Submission Details - K181362

510(k) Number K181362 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2018
Decision Date February 16, 2019
Days to Decision 269 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
147d slower than avg
Panel avg: 122d · This submission: 269d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDC Device Classification - Class 2, Special Controls

Product Code JDC Prosthesis, Elbow, Constrained, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3150
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 Consultant

Peoples & Associates Consulting, LLC
Stephen Peoples

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - JDC Prosthesis, Elbow, Constrained, Cemented

All 27
Devices cleared under the same product code (JDC) and FDA review panel - the closest regulatory comparables to K181362.
Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow
K181307 · Zimmer, Inc. · Jan 2019
Comprehensive SRS/Nexel Elbow
K153398 · Biomet Manufacturing Corp · Feb 2016
Zimmer Nexel Total Elbow Ulnar Cement Diverter
K150501 · Zimmer, Inc. · Apr 2015
ZIMMER NEXEL TOTAL ELBOW
K123862 · Zimmer, Inc. · Mar 2013
DISCOVERY ELBOW - X-SMALL
K090473 · Biomet Manufacturing Corp · Mar 2009
ACCLAIM TOTAL ELBOW SYSTEM
K060696 · DePuy Orthopaedics, Inc. · Apr 2006