Cleared Traditional

K161120 - SMR TT Metal Back Glenoid

K161120 is the FDA 510(k) clearance for SMR TT Metal Back Glenoid 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 306-day FDA review.

K161120 · Lima Corporate S.P.A. · Orthopedic device
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Feb 2017
Decision
306d
Days
Class 2
Risk

K161120 is an FDA 510(k) clearance for the SMR TT Metal Back Glenoid, Bone Graft instruments. 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 February 21, 2017 after a review of 306 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 K161120 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2016
Decision Date February 21, 2017
Days to Decision 306 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
184d slower than avg
Panel avg: 122d · This submission: 306d
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

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 - PHX Shoulder Prosthesis, Reverse Configuration

All 180
Devices cleared under the same product code (PHX) and FDA review panel - the closest regulatory comparables to K161120.
Medacta Shoulder System
K170452 · Medacta International S.A. · Oct 2017
ASHCOM Shoulder System, Anatomical Shoulder System and Anatomical Shoulder Combined System
K170711 · Zimmer GmbH · Jun 2017
Exactech Equinoxe Reverse Shoulder Locking Cap, Exactech Equinoxe Reverse Shoulder Compression Screws, Exactech Equinoxe Reverse Shoulder Glenosphere Locking Screw
K162325 · Exactech, Inc. · Mar 2017
Exactech® Equinoxe® Preserve Stem
K162726 · Exactech, Inc. · Feb 2017
Aequalis PerFORM Reversed, Aequalis PerFORM+ Reversed Glenoid
K161742 · Tornier, Inc. · Nov 2016
Integra TITAN Reverse Shoulder System
K161189 · Integra LifeSciences Corporation · Aug 2016