(168 days)
The SEVIIN Surface Replacement Shoulder is indicated for hemi or total shoulder replacement in patients where the humeral head and neck are of sufficient bone stock and there is an intact or reconstructable rotator cuff.
Hemi or total shoulder replacement is indicated to relieve severe pain or significant disability caused by:
- Rheumatoid arthritis .
- Non-inflammatory degenerative joint disease (osteoarthritis and avascular necrosis) .
- Correction of functional deformity .
- Humeral head fractures . ●
- Traumatic arthritis .
The SEVIIN Resurfacing Humeral Heads are intended for cemented and uncemented applications. The glenoid components, when used, are intended for cemented use only.
The SEVIIN Surface Replacement Shoulder is a hemi or total shoulder prosthesis designed for use in patients where the humeral head and neck are of sufficient bone stock and there is an intact or reconstructable rotator cuff. The design requires minimal bone resection, thus giving the patient an alternative to other total shoulder designs where more bone is removed. Additionally, the SEVIIN Surface Replacement Shoulder can be revised to a longer stemmed total shoulder if necessary.
The Resurfacing Humeral Heads are manufactured from Co-Cr-Mo alloy conforming to ASTM F799 and have a polished spherical surface for atticulation. The inner surface of the humeral heads is coated with titanium plasma spray. Three sizes of humeral heads are available: 42mm, 48mm and 52mm diameter with a stem that is tapered and fluted to provide stability in the humerus.
The Surface Replacement humeral heads are compatible with the previously cleared SEVIIN Total Shoulder Glenoids (K043346) for total shoulder replacement.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices | The SEVIIN Surface Replacement Shoulder was determined to be substantially equivalent to the predicate devices (Copeland MB Resurfacing Humeral Heads, K010657, and Tornier Aequalis Resurfacing Head, K062661) based on intended use, indications, materials, size ranges, and design intent. |
| Adequate Fixation | Non-clinical torsional testing of the Resurfacing Humeral Head fixation indicated that all components are adequate for their intended use. |
2. Sample Size Used for the Test Set and Data Provenance
No specific test set or clinical data was used for this 510(k) submission. The device's substantial equivalence was demonstrated through non-clinical testing and comparison to predicate devices, not through a separate clinical test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. No clinical test set requiring expert ground truth was utilized. The determination of substantial equivalence was made by the FDA's Office of Device Evaluation based on the provided documentation and comparison to predicate devices.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set requiring adjudication was performed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC comparative effectiveness study was not conducted as part of this 510(k) submission.
6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study
Not applicable. The SEVIIN Surface Replacement Shoulder is a physical medical device (implant), not a software algorithm, and therefore, a standalone algorithm performance study is not relevant.
7. Type of Ground Truth Used
The "ground truth" for demonstrating substantial equivalence was established through a comparison to legally marketed predicate devices, specifically their established safety and effectiveness profiles, as well as the results of non-clinical (mechanical/torsional) testing of the device itself.
8. Sample Size for the Training Set
Not applicable. This is not a study involving a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set was Established
Not applicable. There was no training set for an AI/ML algorithm.
§ 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.