Cleared Traditional

K243826 - SMR Reverse HP Shoulder System

K243826 is the FDA 510(k) clearance for SMR Reverse HP Shoulder System by Lima Corporate S.P.A.. It is a Class 2 Orthopedic device (product code PHX) cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K243826 · Lima Corporate S.P.A. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jul 2025
Decision
203d
Days
Class 2
Risk

K243826 is an FDA 510(k) clearance for the SMR Reverse HP Shoulder System. Classified as Shoulder Prosthesis, Reverse Configuration (product code PHX), Class II - Special Controls.

Submitted by Lima Corporate S.P.A. (Udine, IT). The FDA issued a Cleared decision on July 3, 2025 after a review of 203 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3660 - 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

Submission Details

510(k) Number K243826 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 2024
Decision Date July 03, 2025
Days to Decision 203 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
81d slower than avg
Panel avg: 122d · This submission: 203d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PHX Shoulder Prosthesis, Reverse Configuration
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3660
Definition Intended To Be Used To Relieve Pain And To Replace The Glenoid And Humeral Side Of The Shoulder Joint In Order To Restore Mobility In A Grossly Rotator Cuff Deficient Joint With Severe Arthropathy Or A Previous Joint Replacement With A Grossly Rotator Cuff Deficient Joint.
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

Mcra, LLC
Sarah Pleaugh

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 - PHX Shoulder Prosthesis, Reverse Configuration

All 178
Devices cleared under the same product code (PHX) and FDA review panel - the closest regulatory comparables to K243826.
JARVIS Glenoid Reverse Shoulder Prosthesis
K252411 · FH Industrie · Aug 2025
AltiVate Reverse® Glenoid
K252141 · Encore Medical, L.P. · Aug 2025
Equinoxe® Shoulder System
K243448 · Exactech, Inc. · Aug 2025
restor3d Reverse Total Shoulder Arthroplasty System
K243643 · Restor3d · May 2025
AltiVate Reverse Shoulder System
K251184 · Encore Medical, L.P. · May 2025
JARVIS Glenoid Reverse Shoulder Prosthesis
K242253 · FH Industrie · Nov 2024