(52 days)
The PRIMA Humeral System is intended for partial or total, primary or revision, shoulder joint replacement in skeletally mature 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 Short Stem and PRIMA Short Stem Plus are intended for use in cementless and cemented applications, at the discretion of the surgeon.
The PRIMA Anatomic implant is indicated for partial or total, primary or revision shoulder joint replacement, in patients suffering from pain and disability due to:
- . Non-inflammatory degenerative joint disease (i.e. osteoarthritis),
- Inflammatory arthritis of the glenohumeral join including rheumatoid arthritis, .
- Avascular necrosis of the humeral head, ●
- . Traumatic/post-traumatic arthritis,
- Fractures of the humeral head where adequate fixation can be achieved and adequate bone . stock remains,
- . Post-fracture deformity with intact rotator cuff, where adequate fixation can be achieved and adequate bone stock remains,
- . Cuff tear arthropathy (CTA Heads only).
The PRIMA Reverse implant is indicated for primary reverse total shoulder replacement or for revision when converting an anatomic PRIMA arthroplasty to a reverse total shoulder arthroplasty (i.e. in case of cuff tear arthropathy or in a grossly rotator cuff deficiency joint with severe arthropathy).
Revision surgery with retention of the PRIMA Short Stem and PRIMA Short Stem Plus are intended as conversion surgery from anatomic to reverse, where the stem is stable, well positioned and tissue integrated. Other revisions of the humeral prosthesis part should be treated with traditional shoulder prostheses.
The PRIMA reverse implant is indicated for patients suffering from pain and disability due to:
- Rotator cuff tear arthropathy,
- Osteoarthritis with rotator cuff tear,
- Rheumatoid arthritis with rotator cuff tear,
- Massive irreparable rotator cuff tear,
- Avascular necrosis of the humeral head,
- Correction of functional deformity, where adequate fixation can be achieved and adequate bone stock remains,
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.
This 510(k) submission aims at introducing new components to the previously cleared PRIMA Humeral (K212800) and Glenoid (K222427) systems.
The PRIMA Short Stem Plus is introduced as part of the PRIMA Humeral System. As the already cleared PRIMA Short Stem, the PRIMA Short Stem Plus is a convertible short stem component with proximal (metaphyseal) fixation with Trabecular Titanium to be used in both anatomic and reverse configurations. Depending on the configuration, the stem component can be coupled with an Adaptor for the humeral heads for the anatomic configuration and with a Reverse Tray and Reverse Insert in reverse configuration.
The PRIMA Short Stem Plus is intended for use in cementless and cemented applications.
The PRIMA Short Stem Plus is made of Ti6A14V (ISO 5832-3) and is available in two different lengths: 86 mm and 96 mm. Each length is available in seven different sizes, varying from 28mm to 40mm in the proximal diameter.
The PRIMA TT Glenoid Central Compressive Cortical and Cancellous Screws in length 20mm are introduced as part of the PRIMA Glenoid System, as an additional option to the already available sizes (length 25 to 50mm), cleared via K222427. The PRIMA TT Glenoid Central Compressive Cortical and Cancellous Screws are intended to be inserted in the central hole of the glenoid baseplate and are used to fix the PRIMA TT Glenoid baseplates to the glenoid bone.
As for the already cleared central compressive screws of PRIMA TT Glenoid, the PRIMA TT Glenoid Central Compressive Cortical and Cancellous Screws in length 20 mm are manufactured from Ti6A14V (ASTM F1472, ISO 5832-3) and have respectively diameter 5mm (cortical) and 6.5mm (cancellous).
The provided document is a 510(k) Premarket Notification from the FDA, which assesses the substantial equivalence of medical devices to legally marketed predicate devices. It does not contain information about acceptance criteria or a study proving that a device meets specific performance criteria related to AI or diagnostic accuracy.
The document describes the PRIMA Humeral System and PRIMA TT Glenoid devices, which are shoulder joint replacement prostheses. The review focuses on their substantial equivalence in terms of intended use, design, materials, and mechanical non-clinical testing to previously cleared devices.
Therefore, I cannot provide an answer based on the given prompt about acceptance criteria and a study proving device performance in the context of diagnostic accuracy or AI assistance, as this information is not present in the provided text.
Specifically, the document states:
- "Clinical testing was not necessary to demonstrate substantial equivalence of PRIMA Humeral System and PRIMA TT Glenoid to the predicate devices." (Page 8)
This confirms that no clinical study for performance (like diagnostic accuracy, AI assistance, or human reader improvement) was conducted or needed for this particular 510(k) clearance.
§ 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.”