(86 days)
The VerSys Beaded Hip Prosthesis is designed to achieve biologic fixation to bone and is indicated for:
- Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis, disability due to previous fusion, previously failed endoprotheses and/or total hip components in the affected extremity, and acute femoral neck fractures.
- Hemi-hip replacement for the following: fracture dislocation of the hip, elderly, debilitated patients when a total hip replacement is contraindicated, irreducible fractures in which adequate fixation cannot be obtained, certain high subcapital fractures and comminuted fractures, secondary avascular necrosis of the femoral head, pathological fractures of the femoral neck, and osteoarthritis in which the femoral head is primarily affected.
The VerSys Beaded Hip is a modular stem manufactured from Zimaloy® Cobalt-Chromium-Molybdenum Alloy and has a sintered Co-Cr-Mo alloy bead porous surface coating. The prosthesis features a 12/14 Morse-type taper to accommodate the attachment of modular Co-Cr-Mo alloy or zirconia ceramic femoral heads. Proximal body geometry of the VerSys Beaded Hip is trapezoidal and two body options (standard and large metaphysis) are offered in select sizes to meet patient anatomical requirements. The VerSys Beaded Hip Prosthesis is available in two porous coating length options, a midcoat option and a fullcoat option. The distal shaft of the midcoat stem has longitudinal splines. Flutes (grooves, channels) are featured on the distal anterior and posterior surfaces of the midcoat stem.
The provided text (Premarket Notification K973714 for the VerSys® Hip System Beaded Hip Prosthesis) does not contain information regarding acceptance criteria or a study that proves the device meets specific performance criteria.
This document is a 510(k) submission summary, which primarily focuses on demonstrating substantial equivalence to predicate devices already on the market, rather than proving the device meets specific quantitative performance acceptance criteria through a dedicated study with statistical endpoints.
Here's a breakdown of why the requested information cannot be extracted from this document, and what the document does convey:
- A table of acceptance criteria and the reported device performance: This document does not establish specific quantitative acceptance criteria (e.g., minimum tensile strength, maximum wear rate, specific clinical outcome scores). It rather identifies the device and lists its indications for use.
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set, sample size, or data provenance from a specific study are mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): This is not applicable as no "test set" with "ground truth" adjudicated by experts is referenced.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a hip prosthesis, not an AI diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a hip prosthesis, not an AI algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable. This document is not about a machine learning model.
- How the ground truth for the training set was established: Not applicable.
What the document does provide regarding device performance or safety:
- Substantial Equivalence: The primary "proof" in this 510(k) is the demonstration of substantial equivalence to predicate devices (Beta System, AML Total Hip System with Porocoat, Prodigy Hip Prosthesis). The argument is that since these predicates are safe and effective, and the new device is substantially equivalent in design, materials, and intended use, it is also safe and effective.
- Device Description: Details on material (Zimaloy® Cobalt-Chromium-Molybdenum Alloy, sintered Co-Cr-Mo alloy bead porous surface coating), features (12/14 Morse-type taper, trapezoidal body, midcoat/fullcoat options, longitudinal splines, flutes).
- Indications for Use: Extensive list for both total hip replacement and hemi-hip replacement.
- Clinical Data (Statement): The document states: "Many studies published in the literature report that satisfactory results have been obtained with the use of hip prostheses that are substantially equivalent to the VerSys Beaded Hip Prosthesis." This refers to existing literature on similar devices, not a new study conducted for this specific device.
In summary, this 510(k) submission relies on the concept of substantial equivalence, meaning it demonstrates that the VerSys® Hip System Beaded Hip Prosthesis is as safe and effective as legally marketed predicate devices, and therefore does not include a de novo study with specific acceptance criteria and performance data for the device itself.
§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. 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. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.