Cleared Traditional

K222807 - TEMA Elbow system - Line extension

K222807 is the FDA 510(k) clearance for TEMA Elbow system - Line extension by Lima Corporate S.P.A.. It is a Class 2 Orthopedic device (product code JDB) cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K222807 · Lima Corporate S.P.A. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2022
Decision
40d
Days
Class 2
Risk

K222807 is an FDA 510(k) clearance for the TEMA Elbow system - Line extension. Classified as Prosthesis, Elbow, Semi-constrained, Cemented (product code JDB), 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 October 26, 2022 after a review of 40 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Lima Corporate S.P.A. devices

Submission Details

510(k) Number K222807 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2022
Decision Date October 26, 2022
Days to Decision 40 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
82d faster than avg
Panel avg: 122d · This submission: 40d
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 Consultant

Lima U.S.A., Inc.
Kenneth Newman

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 - JDB Prosthesis, Elbow, Semi-constrained, Cemented

All 22
Devices cleared under the same product code (JDB) and FDA review panel - the closest regulatory comparables to K222807.
LATITUDE EV™ Total Elbow Arthroplasty
K193247 · Tornier, Inc. · Aug 2020
LATITUDE EV Total Elbow Arthroplasty
K182461 · Tornier, Inc. · Dec 2018
Latitude EV Total Elbow Arthroplasty
K171010 · Tornier, Inc. · Aug 2017
LATITUDE ELBOW PROSTHESIS
K100562 · Tornier, Inc. · Jun 2010
LATITUDE ELBOW PROTHESIS
K070787 · Tornier · Aug 2007
RHS
K060438 · Tornier · Apr 2006