Cleared Traditional

SMR TT Metal Back Glenoid, Bone Graft instruments (K161120) - FDA 510(k) Clearance

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

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
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 Peers - PHX Shoulder Prosthesis, Reverse Configuration

All 139
Devices cleared under the same product code (PHX) and FDA review panel - the closest regulatory comparables to K161120.
Zimmer Trabecular Metal Reverse Shoulder System, Mini Glenoid
K172767 · Zimmer, Inc. · Nov 2017
Medacta Shoulder System
K170452 · Medacta International S.A. · Oct 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
Exactech Equinoxe Reverse Shoulder 46x21mm Glenosphere
K150458 · Exactech, Inc. · May 2015
Univers Rivers Shoulder Prosthesis System
K142863 · Arthrex, Inc. · Nov 2014