Cleared Traditional

K110598 - SMR REVERSE SHOULDER SYSTEM

K110598 is the FDA 510(k) clearance for SMR REVERSE 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 169-day FDA review.

K110598 · Lima Corporate S.P.A. · Orthopedic device
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Aug 2011
Decision
169d
Days
Class 2
Risk

K110598 is an FDA 510(k) clearance for the SMR REVERSE SHOULDER SYSTEM. Classified as Shoulder Prosthesis, Reverse Configuration (product code PHX), Class II - Special Controls.

Submitted by Lima Corporate S.P.A. (Winona Lake, US). The FDA issued a Cleared decision on August 18, 2011 after a review of 169 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 K110598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2011
Decision Date August 18, 2011
Days to Decision 169 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
47d slower than avg
Panel avg: 122d · This submission: 169d
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 180
Devices cleared under the same product code (PHX) and FDA review panel - the closest regulatory comparables to K110598.
AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM
K112615 · Tornier, Inc. · Oct 2011
REVERSE SHOULDER PROSTHESIS MONOBLOCK HEMI ADAPTER
K111735 · Encore Medical, L.P. · Oct 2011
TURON RSP SOCKET SHELL-NEUTRAL MODEL 508-02-000, TURON RSP SOCKET SHELL-OFFSET MODEL 508-02-001
K111629 · Encore Medical, L.P. · Sep 2011
REVERSE SHOULDER MONOBLOCK PROSTHESIS (RSP)
K111061 · Encore Medical, L.P. · Jul 2011
AEQUALIS ASCEND MODULAR REVERSE SHOULDER SYSTEM
K110599 · Tornier, Inc. · Jun 2011
EQUINOXE REVERSE SHOULDER COMPRESSION SCREW / 38MM AND 42MM GLENOSPHERE / SUPERIOR AUGMENT GLENOID PLATE, 10 DEGREES...
K110708 · Exactech, Inc. · Apr 2011