Cleared Traditional

K200171 - SMR TT Augmented Glenoid System

K200171 is the FDA 510(k) clearance for SMR TT Augmented Glenoid 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 301-day FDA review.

K200171 · Lima Corporate S.P.A. · Orthopedic device
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Nov 2020
Decision
301d
Days
Class 2
Risk

K200171 is an FDA 510(k) clearance for the SMR TT Augmented Glenoid System. Classified as Shoulder Prosthesis, Reverse Configuration (product code PHX), 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 November 19, 2020 after a review of 301 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 K200171 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2020
Decision Date November 19, 2020
Days to Decision 301 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
179d slower than avg
Panel avg: 122d · This submission: 301d
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

Lima U.S.A., Inc.
Lacey Harbour

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 K200171.
Catalyst OrthoScience R1 Reverse Shoulder System
K202611 · Catalyst Orthoscience, Inc. · Feb 2021
LINK Embrace Shoulder System - Reverse Configuration
K200368 · Waldemar Link GmbH & Co. KG · Feb 2021
GLOBAL UNITE™ Platform Shoulder System
K202098 · Depuy Ireland UC · Nov 2020
Univers Revers Modular Glenoid System, Half Augment Baseplate
K200895 · Arthrex, Inc. · Aug 2020
Lateralized Glenosphere
K193175 · Medacta Inernational SA · Aug 2020
Humelock TiN Coated Glenosphere
K191146 · Fx Shoulder USA, Inc. · Jul 2020