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The Ignite Anatomic Shoulder System is intended for use in total or hemi-shoulder replacement procedures 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.
• · Fracture of the humeral head
• · Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate.

Fixation Methods
The humeral stem is intended for cementless use. The glenoid is intended for cemented use only.

The Ignite Anatomic Shoulder System is total shoulder arthroplasty system consisting of humeral heads (38 - 57mm diameters), offset taper adapters (multiple offsets), stems (66-82mm lengths), and glenoid components (multiple sizes).

The anatomic humeral consists of a wrought Cobalt-Chromium Humeral Head, a wrought Ti-6Al-4V Taper Adapter, and an additively manufactured Ti-6Al-4V Stem.

The All-Poly Anatomic Glenoid consists of Crosslinked Alpha-Tocopherol (Vitamin-E) infused Ultra-High-Molecular-Weight-Polyethylene. This device also has a 316L stainless steel pin pressed into it as an x-ray marker.

The system is provided with a set of instruments designed for preparation of the implant site and insertion of the implants into bone.

The provided FDA 510(k) document is for the Ignite Anatomic Shoulder System, a medical device. This document describes the device itself and its equivalence to previously cleared devices. It does not contain information about an AI/ML powered device or a study involving acceptance criteria for such a device.

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance tables, sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details.

The document explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence of the Ignite Anatomic Shoulder System to the predicate devices." This indicates that the regulatory clearance was based on non-clinical testing and comparison to predicate devices, not on a clinical study evaluating its performance against specific acceptance criteria in patient populations.

The "Non-Clinical Testing" section lists various mechanical and material-related tests (e.g., Range of Motion, Biocompatibility, Wear Testing, Fatigue Testing) conducted to demonstrate the device's substantial equivalence to predicate devices, but these are for the physical implant itself, not an AI/ML component.

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Total or hemi-shoulder replacement is indicated for:

1. A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis;
2. Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory;
3. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g., revision of a failed primary component).

Hemi-shoulder replacement is also indicated for:

1. Ununited humeral head fractures;
2. Avascular necrosis of the humeral head.

Only the titanium alloy humeral stem components and the cobalt-chrome alloy humeral stem components, which are marketed under either the Global Shoulder or Global Advantage Shoulder name, are intended for press-fit or cemented fixation. The glenoid components are for cemented use only.

The Global Advantage Shoulder consists of a humeral stem and a humeral head. Like the predicate devices, the components are modular in that they employ a morse-type taper lock system, the modular head having the male taper and the body with the female taper. The humeral stem is manufactured titanium alloy (Ti-6Al-4V), while the humeral head is manufactured from cobalt chromium molybdenum alloy.

The Global Advantage humeral stem is similar to the current Global humeral stem in that there are four proximal fins, a proximal collar, and a fluted distal stem. The fins are perforated with suture holes to accommodate the sutures necessary to reconstruct the proximal humerus.

The Global Advantage humeral head is similar to the current Global head in that it is fitted with an identical locking taper, is semi-spherical in design, and is also available in an offset eccentric head.

The provided text is a 510(k) Pre-market Notification for the Global™ Advantage Shoulder. This document focuses on demonstrating substantial equivalence to previously cleared devices, rather than presenting a study with specific acceptance criteria and performance metrics for a novel device. Therefore, the requested information about acceptance criteria, performance studies, sample sizes, expert involvement, and ground truth establishment is not available within this document.

The document explicitly states:

• "The fundamental scientific technologies of the Global Advantage humeral stem and head have not changed from the FDA cleared (K911686, K974044 and K984541) Global Shoulder humeral stem and head."
• "The intended use and indications for use of the Global Advantage humeral stem and humeral head have not changed from the FDA cleared (K911686) Global Shoulder, Global Eccentric Humeral Head (K974044) and Global Fx (K984541)."
• "With the exception of minor design modifications, the Global Advantage humeral stem and humeral head are identical to the Global Shoulder devices cleared in K911686, K974044 and K984541."

This type of submission relies on the established safety and effectiveness of the predicate devices. The "study" here is essentially a comparison to predicate devices to assert substantial equivalence, not an independent performance study against defined acceptance criteria for the new device.

Therefore, I cannot populate the table or answer the subsequent questions with information from this document because it describes a claim of substantial equivalence, not a standalone performance study with acceptance criteria.

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Total or hemi-shoulder replacement is indicated for:

1. A severely painful and/or disabled joint resulting from osteoarthritis, traumatic arthritis or rheumatoid arthritis;
2. Fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment are unsatisfactory;
3. Other difficult clinical problems where shoulder arthrodesis or resection arthroplasty are not acceptable (e.g., revision of a failed primary component).

Hemi-shoulder replacement is also indicated for:

1. Ununited humeral head fractures;
2. Avascular necrosis of the humeral head.

Only the titanium alloy humeral stem components and the cobalt-chrome alloy humeral stem components, which are marketed under the Global Shoulder name, are intended for press-fit or cemented fixation. The glenoid components are for cemented use only.

The Global Shoulder components, which are the subjects of this submission, consist of a humeral body (stem) and a humeral head. Like the predicate devices, the components are modular in that they employ a morse-type taper lock system, the modular head having the male taper and the body with the female taper. Both components (head and body) will be made from Co-Cr-Mo alloy.

The subject Global humeral stem is similar to the current Global humeral stem in that there are four proximal fins, a proximal collar, and a fluted distal stem. The fins are perforated to accommodate the sutures necessary to reconstruct the proximal humerus.

The Global humeral head is similar to the current Global head in that it is fitted with an identical locking taper, is semi-spherical in design, and it has similar head sizes and heights. The size range will allow options for joint tensioning and restoration of normal joint biomechanics.

Modifications and Reason: Although the currently marketed design already includes the indication for use in fracture cases, the need for a smaller proximal humeral stem has been identified for those patients with smaller metaphyses and for use in fracture cases when the predicate Global humeral component is too large for the particular patient. DePuy believes the subject humeral components, containing the following described modifications, fill this need.

• The proximal humeral body has been reduced in the A/P and M/L dimensions to ease repositioning of the fractured humeral tuberosities.
• The lateral fin has a reduced profile to prevent contact with the biceps tendon and to avoid tilting the prosthesis in a varus orientation.
• The medial fin has a suture hole added for passing of sutures to reposition fractured tuberosities.
• The lateral fin has one centrally located suture hole versus the three suture holes in the current design.
• The collar diameter has been reduced and contains a flat profile to mate with humeral heads.
• The humeral head has been modified to contain a recess in the undersurface in order to mate with the collar of the humeral stem component. The collar/head design reduces collar/head gap and increases the effective articular surface area.

The provided text is a 510(k) Summary of Safety and Effectiveness for the DePuy Global™ Shoulder device, specifically the Global™ Fx Humeral Stem and Global™ Advantage® Humeral Head.

This document describes the device, its intended use and indications, and the basis for its substantial equivalence to previously cleared devices. It does not contain information about acceptance criteria or a study proving that the device meets those criteria, as one would typically find for a medical AI or diagnostic device.

Instead, this document focuses on demonstrating that the modified components (Global™ Fx Humeral Stem and Global™ Advantage® Humeral Head) are substantially equivalent to existing, already-cleared Global Shoulder components (K911686, K914695). The "acceptance criteria" here implicitly refer to the FDA's regulatory requirements for substantial equivalence for a medical device that does not involve AI or a diagnostic algorithm.

Therefore, I cannot provide the requested information in the format because the provided document does not contain:

• A table of acceptance criteria and reported device performance directly related to an AI/diagnostic algorithm.
• Sample sizes for test sets, data provenance, or expert involvement for ground truth establishment.
• Adjudication methods.
• Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance studies.
• Training set details or ground truth establishment for a training set.

The "study" in this context is the comparison of design, materials, manufacturing processes, indications for use, and intended use to predicate devices, as opposed to a clinical performance study with statistical metrics.

Summary of Device and Basis for Equivalence (as presented in the document):

Device: Global™ Fx Humeral Stem and Global™ Advantage® Humeral Head (humeral stem and head components for shoulder arthroplasty).

Basis of Substantial Equivalence:
The document states that the fundamental scientific technology has not changed from previously FDA-cleared Global Shoulder humeral components (K911686). The intended use and indications for use also remain unchanged. The new components address a need for a smaller proximal humeral stem for patients with smaller metaphyses and fracture cases.

Modifications (minor design changes):

• Reduced A/P and M/L dimensions of the proximal humeral body.
• Reduced profile of the lateral fin.
• Added a suture hole to the medial fin.
• Changed lateral fin to one centrally located suture hole (from three).
• Reduced and flattened collar diameter.
• Humeral head modified with a recess in the undersurface to mate with the stem collar.

Conclusion for Equivalence:
DePuy believes the modified components are substantially equivalent to the predicate devices (K911686 and K914695) based on conformance with design control procedures (21 CFR 820.30), similarities in design, commonly used materials, sterilization processes, indications for use, and intended use. The FDA concurred with this assessment for substantial equivalence (K984541).

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