(29 days)
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.
The V40™ femoral head components are fabricated from cobalt chromium alloy conforming to ASTM F799. These devices have an outer diameter range from 22mm to 32mm with varying neck offsets. 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 the LFIT™ V40™ Femoral Head Components, which are hip joint prosthetic components. This document does NOT describe the acceptance criteria and a study that proves a device meets those criteria. Instead, it details:
- Device Identification: Proprietary name, common name, classification, product code.
- Contact Information: For the manufacturer's regulatory affairs.
- Purpose of Submission: To add V40™ femoral head components to an existing product series, asserting their substantial equivalence to predicate devices.
- Predicate Devices: Identification of previously cleared devices and their characteristics (materials, dimensions).
- Correspondence from FDA: An FDA letter confirming substantial equivalence and providing guidance on regulatory compliance.
- Intended Use Statement: Describes the application of the device as modular components in primary or revision total hip arthroplasty.
Given that the document is a 510(k) summary for a hip implant and not a study report, it does not contain the information required to answer your prompt. There are no performance metrics, study designs, sample sizes, expert qualifications, or ground truth details presented here. The submission is based on substantial equivalence to existing devices, meaning its safety and effectiveness are inferred from the predicate devices, rather than through a new, specific performance study with acceptance criteria.
§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A hip joint metal/polymer semi-constrained cemented 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 includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.