(234 days)
No
The summary describes a mechanical implant system and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device replaces resected bone due to severe bone loss, tumor resections, trauma, or failed previous joint replacements, which makes it a medical implant rather than a therapeutic device.
No
This device is a replacement system for severe bone loss in the humerus, not a diagnostic tool. Its intended use is to replace resected bone, not to identify or diagnose medical conditions.
No
The device description clearly states it is a "metallic segmental fixation system" and a "set of Compliant - Pre-Stress implants," indicating it is a physical hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Description and Intended Use: The provided text clearly describes a surgical implant designed to replace a portion of the humerus bone. It is used in vivo (within the body) during surgery, not in vitro (in a lab setting) on a sample.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, detection of biomarkers, or diagnostic purposes.
Therefore, based on the provided information, the Compress® Segmental Humeral Replacement System is a medical device, specifically a surgical implant, and not an IVD.
N/A
Intended Use / Indications for Use
The Compress® Segmental Humeral Replacement System is intended to replace the resected part of the humerus in cases of severe bone loss in either the proximal or distal humerus. The Compress® Segmental Humeral Replacement System components are intended for uncemented use.
The Compress® Segmental Humeral Replacement System is indicated for:
- Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
- Tumor resections.
- Revision of previously failed total joint arthroplasty.
- Trauma.
The Compress® Segmental Humeral Replacement System components are intended for uncemented use.
The Discovery Elbow components when used in conjunction with the Compress® Segmental Humeral Replacement System are restricted to the Compress® Segmental Humeral Replacement System indications and are intended to be inserted with bone cement.
The Modular Hybrid Glenoid when used in conjunction with the Compress® Segmental Humeral Replacement System is restricted to the Compress® Segmental Humeral Replacement System indications and is intended to be used with bone cement. The optional porous titanium peg may be inserted without bone cement. The optional polyethylene peg should be inserted with bone cement.
Product codes
MBF, KWS, KWT, JDC
Device Description
The Compress® Segmental Humeral Replacement System is a metallic segmental fixation system intended to replace the resected part of the humerus in cases of severe bone loss. The design of the Compress® System allows a compressive load to be applied at the prosthetic implant-bone interface at the time of device insertion. This is accomplished through a spring system built into the stem.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
humerus, humeral, elbow, glenoid
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing:
MT-5325 – Mini Compress® Taper Fatigue Test:
Cyclic Fatigue testing of the Mini Compress® taper indicated that all test specimens passed cyclic fatigue testing to ten million cycles without failure.
MT-5326 – Mini Compress® Pull-off Test:
Taper pull-off testing was conducted to determine the pull-off strength of the Mini Compress® taper. Each individual specimen exceeded the minimum acceptance criterion, as did the average pull-off strength.
Clinical Testing:
Clinical testing was not performed to demonstrate substantial equivalence of the subject Compress® Segmental Humeral Replacement System components with the predicate Compress® Segmental Femoral Replacement System components.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K101475, K062998, K033280, K020045
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3670 Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits movement in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral component made of alloys such as cobalt-chromium-molybdenum (Co-Cr-Mo) and titanium-aluminum-vanadium (Ti-6Al-4V) alloys, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, or a combination of an articulating ultra-high molecular weight bearing surface fixed in a metal shell made of alloys such as Co-Cr-Mo and Ti-6Al-4V. The humeral component and glenoid backing have a porous coating made of, in the case of Co-Cr-Mo components, beads of the same alloy or commercially pure titanium powder, and in the case of Ti-6Al-4V components, beads or fibers of commercially pure titanium or Ti-6Al-4V alloy, or commercially pure titanium powder. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis.”
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