Search Results

The Inset Reverse Total Shoulder System should be used in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.

The Inset Reverse Total Shoulder System is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. The System can be used to treat fractures of the humeral head, and revision of other devices if sufficient bone stock remains.

The Glenoid Baseplate is intended for cementless application with the addition of screw fixation. The Humeral Stem may be implanted by press-fit or cement fixation.

This submission represents a product line extension to add the InSet 95 Humeral Stem to the InSet Reverse Total Shoulder System, previously cleared under K210533. No additional modifications are proposed to the cleared InSet Reverse Total Shoulder System components as part of this submission.

The InSet Reverse Total Shoulder System is intended for total shoulder replacement in a reverse shoulder configuration. Unlike traditional (anatomic) total shoulder arthroplasty, a reverse shoulder configuration places the ball component (glenosphere) on the glenoid side and the polyethylene bearing surface on the humeral side. The cleared system (K210533) comprises humeral components—Humeral Stem, Humeral Tray, and Humeral Bearing—and glenoid components—Glenosphere Baseplate, Peripheral Screws, Central Compression Screw (optional), Baseplate Set Screw Locking Nut, Glenosphere, and Glenosphere Locking Bolt. Again, no changes to these cleared components are proposed in this submission.

In the system, the Glenosphere Baseplate is affixed to the native glenoid bone using a Central Compression Screw and Peripheral Screws. The baseplate features a female taper for assembly with the selected Glenosphere. Glenoid components are intended for press-fit, cementless fixation, supplemented by screw fixation. On the humeral side, the selected Humeral Bearing attaches to the Humeral Tray, which is assembled with the Humeral Stem (cleared under K173824). Humeral stems may be used either uncemented (press-fit) or with bone cement.

The materials used in the system include:

• Titanium Alloy (ASTM F136): Used for the humeral stem, glenoid baseplate, modular tray, compression screw, and supplemental screws
• Commercially Pure Titanium (ASTM F67): Used for the porous coating on the proximal portions of the humeral stem and glenoid baseplate
• Cobalt-Chromium Alloy (ASTM F1537): Used for the Glenosphere
• Ultrahigh Molecular Weight Polyethylene (UHMWPE, ASTM F648): Used for the Humeral Bearing

The InSet 95 Humeral Stem is an identical implant component used in both the subject device (InSet Reverse Total Shoulder System with InSet 95 Humeral Stem) and the primary predicate device (Aequalis Ascend FlexFlex Shoulder System, cleared under K122698).

In the subject configuration, the InSet 95 Humeral Stem consists of modular, collarless stems and humeral trays and humeral bearings designed to articulate with a glenosphere component. The stems are made from Titanium Alloy (Ti-6Al-4V) and feature longitudinal fins to enhance rotational stability. The collarless design coupled with the humeral tray helps mitigate the risk of stem subsidence. Each stem has a female Morse-type taper for modular tray attachment. The proximal portion, including the fins, is covered with a rough, porous coating to facilitate uncemented fixation, though cemented use is also permitted.

N/A

Ask a specific question about this device

The Shoulder Innovations Total Shoulder System with Humeral Stemless is intended for use as an orthopedic implant for total shoulder arthroplasty to treat severely painful and/or disabled joint resulting from osteoarthritis or traumatic arthritis.

The Shoulder Innovations Total Shoulder System components are intended for single use only.

The Humeral Stemless components are indicated for press-fit, un-cemented use. The glenoid component is intended for cemented fixation only.

The Shoulder Innovations Total Shoulder System consists of modular humeral stems and heads that articulate with a glenoid component. The humeral stems are collarless, as the humeral head acts as the collar, and manufactured from Titanium Alloy (Ti-GAL-4V) conforming to ASTM F136 with fins to provide rotational stability and are coated with a rough, porous coating. The stems have a female Morse-type taper to interface with the modular humeral heads. The humeral heads are manufactured from CoCr and are available in standard and offset configurations. The heads have a male Morse-type taper to interface with the humeral stems.

The glenoid components of the Total Shoulder System are manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE) with a pegged design intended for cemented fixation.

This submission adds Humeral Stemless Implants to the Shoulder Innovations Total Shoulder System. The Humeral Stemless Implants are similar to the previously cleared humeral short stems (K173824), except that the Humeral Stemless Implants do not include the stem. The Humeral Stemless Implants have fins to provide rotational stability and a female Morse-type taper to interface with modular humeral heads, identical to the humeral short stems (K173824). The Humeral Stemless Implants are manufactured from Titanium Alloy (Ti-6Al-4V) conforming to ASTM F136 with a proximal porous coating of commercially pure titanium according to ASTM F67.

The Humeral Stemless Implants are for press-fit, uncemented use. All Humeral Stemless Implants are compatible with the previously cleared Total Shoulder System humeral heads (K173824) and previously cleared Total Shoulder System glenoid components (K111596 and K192365).

The provided text is a 510(k) premarket notification for a medical device (Shoulder Innovations Total Shoulder System with Humeral Stemless). It outlines the device description, indications for use, and a summary of non-clinical testing and substantial equivalence to predicate and reference devices.

Crucially, it clearly states that "Clinical testing was not necessary to demonstrate substantial equivalence" for this device. This implies that the device's acceptance was based on non-clinical testing and a comparison to already cleared devices, rather than a clinical study evaluating its performance against specific clinical acceptance criteria.

Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving the device meets those criteria, as the document explicitly states no clinical study was performed for this specific submission to demonstrate substantial equivalence.

The provided text does not contain the information requested regarding acceptance criteria related to a clinical study proving device performance. There is no information about:

1. A table of acceptance criteria and reported device performance: No clinical performance metrics or predefined acceptance thresholds are mentioned.
2. Sample size used for the test set and data provenance: No clinical test set.
3. Number of experts used to establish ground truth and their qualifications: Not applicable, as no clinical ground truth was established from expert readings.
4. Adjudication method: Not applicable.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: No such study was conducted.
6. Standalone (algorithm only) performance: Not applicable, as this is a physical medical device, not an AI algorithm.
7. Type of ground truth used: No clinical ground truth was used.
8. Sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set.
9. How ground truth for the training set was established: Not applicable.

The document focuses on non-clinical testing (lever out, pull out, torque out, and fatigue testing) to demonstrate substantial equivalence based on mechanical properties and design similarity to predicate devices, rather than clinical efficacy or diagnostic performance.

Ask a specific question about this device