(29 days)
The subject humeral stem is a single-use, sterile device intended for use in shoulder replacement. It is intended for the reconstruction of the proximal humerus. This humeral stem is intended for primary or revision reconstruction of the shoulder joint.
For use as a Bipolar Shoulder Replacement:
- Aseptic necrosis of the humeral head
- Painful, disabling joint disease of the shoulder resulting from: degenerative arthritis, rheumatoid arthritis, or post-traumatic arthritis.
- Proximal humeral fractures and/or dislocation.
- Clinical management problems where arthodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
- Pathological conditions or age considerations which indicate a more conservative glenoid procedure and avoidance of the use of bone cement in the glenoid.
For use as a Total Shoulder Replacement:
- Aseptic necrosis of the humeral head
- Painful, disabling joint disease of the shoulder resulting from: degenerative arthritis, rheumatoid arthritis, or post-traumatic arthritis.
- Proximal humeral fractures and/or dislocation.
- Clinical management problems where arthodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
- Revision of previous unsuccessful total shoulder replacement, resurfacing or other procedure.
This submission is a line extension to the Solar® ReUnion™ Fracture Stem for fracture humeral stem with no CP Ti plasma spray. Fracture humeral stems will be based on the Solar® ReUnion™ Fracture Stem.
This document is a 510(k) premarket notification for the ReUnion™ HA Fracture Stem, a shoulder prosthesis. The purpose of this notification is to demonstrate substantial equivalence to a legally marketed predicate device, rather than to establish safety and effectiveness through clinical studies with acceptance criteria.
Therefore, the requested information regarding acceptance criteria and a study proving device conformance is not applicable in this context.
Here's why and what the document does provide:
- Substantial Equivalence: The document states, "The ReUnion™ HA Fracture Stem is substantially equivalent to the Solar® ReUnion™ Fracture Stem in regards to intended use, design, materials, and operational principles as humeral components. The engineering analysis demonstrates that the subject components are substantially equivalent in strength to the predicate components."
- Engineering Analysis: The document mentions "engineering analysis" to demonstrate equivalence in strength. This implies non-clinical testing (e.g., mechanical or bench testing) rather than a clinical study with human subjects, ground truth, or expert review. However, no specific details about this engineering analysis (e.g., methods, sample sizes, specific criteria, or results) are provided in the summary.
- Predicate Device: The core of a 510(k) submission is to show that a new device is "substantially equivalent" to a device already on the market (the predicate). This avoids the need for extensive new clinical trials if the risks and performance are considered similar.
In summary, this document does not contain information about:
- Acceptance Criteria and Reported Device Performance: No such table is presented, as clinical performance criteria are typically not required for 510(k) submissions where substantial equivalence is demonstrated through other means (like design and material comparison, and bench testing).
- Sample Size and Data Provenance (for test set): Not applicable, as there's no clinical test set described.
- Number and Qualifications of Experts for Ground Truth: Not applicable.
- Adjudication Method: Not applicable.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable.
- Standalone (Algorithm Only) Performance: Not applicable, as this is a physical medical device, not an AI algorithm.
- Type of Ground Truth Used: Not applicable.
- Sample Size for Training Set: Not applicable.
- How Ground Truth for Training Set was Established: Not applicable.
§ 888.3690 Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.
(a)
Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement (§ 888.3027). This device is not intended for biological fixation.(b)
Classification. Class II.