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The INHANCE SHOULDER SYSTEM with the humeral stemless anchor is intended for use in anatomic total shoulder replacement procedures to address the following:

Osteoarthritis
Post-traumatic arthrosis
Focal avascular necrosis of the humeral head
Previous surgeries of the shoulder that do not compromise the fixation

The INHANCE SHOULDER SYSTEM with a humeral stem is intended for use in anatomic total or hemi-shoulder replacement procedures to address the following:

Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
Rheumatoid arthritis.
Revision where other devices or treatments have failed.
Correction of functional deformity.
Fractures of the humeral head (with Short Humeral Stems).
Fractures of the humeral head and proximal humerus, where other methods of treatments are deemed inadequate (with Standard or Long Stems).
Difficult clinical management problems where other methods of treatment may not be suitable or may be inadequate.

Fixation Methods

The humeral stem is intended for cemented or cementless use. The humeral stemless anchor is intended for cementless use. The anatomic glenoid and anatomic hybrid glenoid are intended for cemented use only. The baseplate components of the convertible glenoids are intended for cementless application with the addition of screw fixation. When a convertible glenoid liner is used, the baseplate is indicated for use with a central screw and three peripheral locking screws that are 25mm or greater in length. The peripheral non-locking screws, peripheral posts and central posts are not indicated for use with the convertible glenoid.

Reverse Total Shoulder

The INHANCE SHOULDER SYSTEM Reverse Total Shoulder with a humeral stem is indicated for primary, fracture or revision total reverse shoulder replacement procedures to address the following. The system is indicated for use in patients whose shoulder joint has a gross rotator cuff deficiency. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The system is also indicated for conversion from an anatomic to reverse shoulder prosthesis without the removal of a well-fixed INHANCE humeral stem.

A severely painful, disabling, arthritic joint
Fractures of the humeral head (with Short Humeral Stems)
Fractures of the humeral head and proximal humerus (with Standard or Long Stems)
Revision of previously failed shoulder joint replacement

Fixation Methods

The humeral stem is intended for cemented or cementless use. The glenoid baseplate components are intended for cementless application with the addition of screw fixation. When a Peripheral Post is used, the baseplate is indicated for use with a Central Screw and two Peripheral Locking Screws that are 25mm or greater in length. The peripheral Non-Locking screws and Central Post are not indicated for use with the Peripheral Post.

Device Description

The INHANCE Reverse Total Shoulder System consists of individually packaged implants: a metal humeral stem (titanium alloy), a shell (titanium alloy), a liner (Cross-Linked, VE UHMWPE) in combination with a glenosphere (cobalt-chromium), a baseplate (titanium alloy), peripheral screws (titanium alloy), a baseplate augment (titanium alloy), and either a central screw (titanium alloy) or a central post (titanium alloy). The purpose of this submission is to add alternate angle humeral liners to the INHANCE reverse shoulder system. The subject device is manufactured from a Cross-linked, VE UHMWPE. Size options include diameter 32mm, 36mm and 40mm with thickness +0mm or +4mm. Standard and Retentive options are available.

AI/ML Overview

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K Number

K212737

Validate with FDA (Live)

Device Name

INHANCE Reverse Shoulder System

Manufacturer

Depuy Ireland UC

Date Cleared

2022-04-21

(234 days)

Product Code

PHX,HSD,KWS,KWT,MBF,PAO

Regulation Number

888.3660

Type

Traditional

Panel

Orthopedic

Age Range

All

Reference & Predicate Devices

K181611,K172351,K130050,K161742,K183077,K062250,K120174,K081620,K071379,K122698,K052906,K193373,K202716,K060692

Predicate For

K221467,K223211,K230831,K241817,K250644,K253624

Intended Use

Anatomic Total Shoulder or Hemi-Shoulder
The INHANCE SHOULDER SYSTEM with the humeral stemless anchor is intended for use in anatomic total shoulder replacement procedures to address the following:

Osteoarthritis
Post-traumatic arthrosis
Focal avascular necrosis of the humeral head
Previous surgeries of the shoulder that do not compromise the fixation

The INHANCE SHOULDER SYSTEM with a humeral stem is intended for use in anatomic total or hemi-shoulder replacement procedures to address the following:

Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
Rheumatoid arthritis.
Revision where other devices or treatments have failed.
Correction of functional deformity.
Fractures of the humeral head (with Short Humeral Stems)
Fractures of the proximal humerus, where other methods of treatment are deemed inadequate (with Standard or Long Stems)
Difficult clinical management problems where other methods of treatment may not be suitable or may be inadequate.

Fixation Methods
The humeral stems are intended for cemented or cementless use. The humeral stemless anchor is intended for cementless use. The glenoid is intended for cemented use only.

Reverse Total Shoulder
The INHANCE SHOULDER SYSTEM Reverse Total Shoulder with a humeral stem is indicated for primary, fracture or revision total reverse shoulder replacement procedures to address the following. The system is indicated for use in patients whose shoulder joint has a gross rotator cuff deficiency. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The system is also indicated for conversion from an anatomic to reverse shoulder prosthesis without the removal of a well-fixed INHANCE humeral stem.

A severely painful, disabling, arthritic joint
Fractures of the humeral head (with Short Humeral Stems)
Fractures of the proximal humerus (with Standard or Long Stems)
Revisions of previously failed shoulder joint replacements

Fixation Methods
The humeral stem is intended for cemented or cementless use. The glenoid baseplate components are intended for cementless application with the addition of screw fixation.

Device Description

The INHANCE™ SHOULDER SYSTEM with a humeral stemless anchor is intended for use in anatomic total shoulder replacement procedures.

The INHANCE SHOULDER SYSTEM with a humeral stem is intended for use in anatomic total, reverse total, or hemi-shoulder replacement procedures.

The Anatomic Total Shoulder Prosthesis consists of individually packaged implants: a metal humeral stem or humeral stemless anchor (titanium alloy), an offset taper adapter (titanium alloy), a humeral head (cobalt-chromium) in combination with a Cross-linked, Vitamin E Ultra High Molecular Weight Polyethylene (Cross-linked, VE UHMWPE) glenoid.

The Reverse Total Shoulder Prosthesis consists of individually packaged implants: a metal humeral stem (titanium alloy), a shell (titanium alloy), a liner (Cross-linked, VE UHMWPE) in combination with a glenosphere (cobalt-chromium), baseplate (titanium alloy), peripheral screws (titanium alloy), and either a central screw (titanium alloy) or a central post (titanium alloy).

The Anatomic Hemi-Shoulder Prosthesis consists of individually packaged implants: a metal humeral stem (titanium alloy) an offset taper adapter (titanium alloy), a humeral head (cobaltchromium) (no glenoid component associated).

AI/ML Overview

The provided text describes the regulatory clearance of a medical device, the INHANCE™ Reverse Shoulder System, and does not contain information about the performance of an AI/ML device. Therefore, it is not possible to answer the requested questions about acceptance criteria, study details, and AI performance.

The document focuses on demonstrating "substantial equivalence" of the device to previously cleared predicate devices through non-clinical testing. It explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence of the INHANCE™ Reverse Shoulder System to the predicate devices."

The non-clinical testing performed includes:

Range of Motion (RoM) Evaluation: Met established specifications per ASTM F1378.
Construct Fatigue Testing: Met acceptance criteria per ASTM F1378.
Construct Loosening and Disassociation: Met acceptance criteria per ASTM F2028-17.
Biocompatibility Assessments: Found to be biocompatible per ISO 10993-1 and FDA Guidance.
Porous Structure Characterization: Identical to previously cleared devices.
Characterization of VE-UHMWPE: Fully characterized in a previous submission (K202716).
Evaluation of Wear Rate: Wear rate was lower than a predicate device, meeting acceptance criteria.
MRI Compatibility: Quantitative data obtained per ASTM standards (F2052-15, F2213-17, F2182-19e2, F2119-07).
Shelf Life Evaluation: A five-year shelf life established per ISO 11607-1 and ISO 11607-2.
Sterilization Validation: Sterility Assurance Level (SAL) of 10^-9 found per ISO 11137-1 and ISO 11137-2.

These are all engineering and material performance tests for a physical implant, not an AI/ML algorithm or software.

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