(36 days)
The Ascension® HRA® device is intended for resurfacing of the humeral head due to:
- . Patients disabled by either non-inflammatory or inflammatory arthritis (i.e. rheumatoid arthritis, osteoarthritis and avascular necrosis).
- . Mild or moderate humeral head deformity and / or limited motion.
- . Post-traumatic arthritis.
- . Malunions of the humeral head.
- . Acute fractures of the humeral head
- . Patients with an intact or reparable rotator cuff.
The Ascension® HRA® System includes an anatomically designed, semi-constrained, monolithic device designed for resurfacing of the humeral head (hemi-shoulder). The system is designed for non-cemented (i.e. press-fit) fixation. Each device is boxed individually and delivered sterile for single use. The system incorporates eight anatomically designed head geometries with appropriately sized stems. Head sizes are identified using width and height (in millimeters). The Ascension® HRA® device incorporates design features for replacing the damaged humeral head bearing surface and restoring normal anatomy with minimal bone resection. The stem is tapered and fluted to provide rotational as well as axial stability of the seated implant. System instrumentation, including a range of implant trials, is designed to offer precise implant preparation. The HRA device is made from Cobalt Chrome (ASTM F-1537 wrought or ASTM F-75 cast) and features a highly polished bearing surface with a CP Titanium plasma spray under-surface and stem coating to enhance osseointegration. No new materials are introduced with this device. Ascension HRA® System components will be manufactured by contract manufacturers per Ascension Orthopedics, Inc., specifications.
This document, a 510(k) summary for the Ascension® HRA® (Humeral Resurfacing Arthroplasty) device, does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.
Instead, this document focuses on demonstrating substantial equivalence to predicate devices, which is the basis for 510(k) clearance. Substantial equivalence means the new device is as safe and effective as a legally marketed device (predicate device) and does not raise new questions of safety or effectiveness.
Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, expert involvement, or ground truth.
The document primarily provides:
- Device description: Anatomically designed, semi-constrained, monolithic device for humeral head resurfacing. Made from Cobalt Chrome with a CP Titanium plasma spray coating.
- Intended Use: Resurfacing of the humeral head due to various types of arthritis, deformity, fractures, and malunions, specifically for patients with an intact or reparable rotator cuff.
- Contraindications: Infection, osteoporosis, metabolic disorders, osteomalacia, rapid joint destruction, and failed revision procedures.
- Basis of Substantial Equivalence: A detailed comparison table between the Ascension® HRA® device and two predicate devices (Biomet Copeland Humeral Resurfacing Head and DePuy Global C.A.P.) across various specifications and characteristics (e.g., materials, use, implantation duration, constraint, sizes, fixation methods).
- FDA Clearance Letter: Confirmation of 510(k) clearance (K062861) based on substantial equivalence.
The core of the "proof" in this document is the claim of substantial equivalence to already cleared devices, not a study demonstrating a new device's direct performance against predefined acceptance criteria.
§ 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.