Search Results
Found 1 results
510(k) Data Aggregation
(29 days)
36MM V40 FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT)
These devices are modular components of a total hip system. These femoral heads are intended for use with femoral stems and acetabular components in primary or revision total hip arthroplasty.
This Special 510(k) submission is intended to add 36mm V40™ femoral head components in -5mm, +0mm, +5mm and +10mm offsets to the LFIT™ and non-LFFTTM Femoral Bearing Series. The intended use, manufacturing methods, materials, packaging and sterilization of the subject device are identical to those of predicate devices. The V40™ femoral head components are fabricated from Cobalt Chromium Alloy conforming to ASTM F1537. Like the predicate devices, the subject devices are intended for use with femoral stems and acetabular components in primary or revision total hip arthroplasty.
The provided text is a 510(k) summary for a medical device (femoral head components) and does not describe a study involving acceptance criteria for an AI/algorithm-driven device. It is a regulatory submission for a physical hip implant component. Therefore, the requested information about acceptance criteria, study details, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, and training set information is not applicable to this document.
The document indicates that the 36mm V40™ Femoral Head Components are being added to existing product lines (LFIT™ and non-LFIT™ Series) and asserts that the "intended use, manufacturing methods, materials, packaging and sterilization of the subject device are identical to those of predicate devices." The regulatory process relies on demonstrating substantial equivalence to these predicate devices.
Summary of Device and Predicate:
| Attribute | Subject Device | Predicate Device |
|---|---|---|
| Proprietary Name: | 36mm V40™ Femoral Head Components (LFIT™ and Non-LFIT™) | 22mm-32mm V40™ Femoral Head Components (LFIT™ and Non-LFIT™) |
| Common Name: | Femoral Head Component | Femoral Head Component |
| Classification Name & Reference: | 21 CFR §888.3350 Hip Joint Metal/Polymer Semi-Restrained Cemented Prosthesis | 21 CFR §888.3350 Hip Joint Metal/Polymer Semi-Restrained Cemented Prosthesis |
| Proposed Regulatory Class: | II | II |
| Device Product Code: | (87) JDI, LWJ, KWY | (87) JDI, LWJ, KWY |
| Intended Use: | Modular components of a total hip system; intended for use with femoral stems and acetabular components in primary or revision total hip arthroplasty. | Modular components of a total hip system; intended for use with femoral stems and acetabular components in primary or revision total hip arthroplasty. (Implied, as subject device is "identical") |
| Materials: | Cobalt Chromium Alloy conforming to ASTM F1537 | Cobalt Chromium Alloy conforming to ASTM F1537 (Implied, as subject device is "identical") |
The core of this 510(k) submission is to demonstrate substantial equivalence to previously cleared predicate devices, by showing that the new 36mm size head, despite being larger, shares the same fundamental characteristics, materials, and intended use as the smaller cleared predicate devices. There is no performance study described in the context of acceptance criteria for an AI or algorithm.
Ask a specific question about this device
Page 1 of 1