(56 days)
The PRIMA Glenoid System is indicated for primary, fracture or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy (disabled shoulder). The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.
The PRIMA Glenoid System components are intended for uncemented use with the addition of screw fixation.
The PRIMA TT Glenoid, that is part of the PRIMA Glenoid System, is a modular shoulder system intended to be used in combination with the previously cleared humeral components of the SMR Shoulder System (K220792) and PRIMA Humeral System (K212800).
The new system components include a monoblock glenoid baseplate, a modular glenoid baseplate and the related glenoid peg, a glenosphere connector with screw, central and peripheral bone screws and locking caps.
The baseplates are provided in different angulations, ranging between 10° and 20°, and in different offsets, up to +4mm lateralization. The glenosphere has articular diameter 36, 40 and 42mm and the connector with screw is available in low, medium and high lateralization. Central compressive screws are available in dia. 5 and 6.5mm and in length ranging between 25 and 50mm, while peripheral screws are available in dia. 5mm and in length ranging between 18 to 50mm.
Baseplates, peg, screws and locking cap are made of Ti6Al4V, the glenosphere is made of CoCrMo and the glenosphere connector with screw is made of Ti6Al4V and UHMWPE.
This document is a 510(k) Premarket Notification for the PRIMA TT Glenoid, a shoulder implant system. It primarily focuses on demonstrating substantial equivalence to predicate devices through non-clinical (mechanical) testing, and explicitly states that clinical testing was not necessary. Therefore, this document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria based on clinical performance data.
Specifically, the document states: "Clinical testing was not necessary to demonstrate substantial equivalence of PRIMA TT Glenoid to the predicate devices."
As a result, I cannot provide the detailed information requested in points 1-9 regarding a study that proves the device meets acceptance criteria through clinical performance. The provided text only discusses non-clinical mechanical testing for equivalence.
However, I can extract information related to the non-clinical testing performed:
Non-clinical Testing Information Provided:
- Type of Testing: Mechanical tests.
- Purpose: To demonstrate that device performance fulfilled the intended use and that the device is substantially equivalent to the predicate devices.
- Tests Performed:
- Evaluation of modular connection dissociation strength
- Fatigue fretting test on glenoid baseplates in reverse shoulder configuration
- Evaluation of modular connection dissociation strength post-fatigue
- Dynamic Evaluation of the Glenoid Loosening or Disassociation (ASTM F2028)
- Evaluation of range of motion for worst case devices
- Components Tested: Worst case components or constructs.
Since clinical performance data and associated acceptance criteria are not present in the provided text, the table for clinical acceptance criteria and the detailed study information cannot be generated from this document.
§ 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.”