Cleared Traditional

K222807 - TEMA Elbow system - Line extension (FDA 510(k) Clearance)

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K222807 · Lima Corporate S.P.A. · Orthopedic device
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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.