← Back to catalogue

Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups

FDA 510(k)

Class II (US FDA 510(k))

510(k) K182705

by B-One Ortho, Corp.

Identifiers

510(k) Number
K182705 FDA 510(k)
FDA Product Code
LZO FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3353 FDA 510(k)
Regulation Number
888.3353 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups is a Prosthesis, Hip, Semi-constrained, Metal/Ceramic/Polymer, Cemented designed for total hip arthroplasty. It combines a femoral stem with primary acetabular cups to restore hip function in patients with severe joint degradation, including osteoarthritis, avascular necrosis, or degenerative joint disease. The system is constructed with metal, ceramic, and polymer components to ensure durability and biomechanical compatibility.

This device is supplied as a modular orthopedic implant system, intended for use in surgical settings by trained orthopedic surgeons. It is classified under FDA product code LZO and requires cement fixation for placement. The system is regulated under FDA 510(k) clearance (K182705) and is intended for primary hip replacement procedures in skeletally mature patients. Sterility and single-use or reusable status are not specified in the provided data.

Frequently asked questions

What types of hip joint issues is this system specifically designed to address in patients?

The Juveno Hip System is designed for total hip arthroplasty in patients with severe joint degradation, including osteoarthritis, avascular necrosis, or degenerative joint disease. It is intended to restore hip function by replacing damaged components with a modular metal, ceramic, and polymer implant system.

How is the Juveno Hip System secured in place during surgery?

This system requires cement fixation for placement, meaning bone cement is used to anchor the femoral stem and acetabular cups during surgery. This method ensures stable integration with the patient’s existing bone structure.

Is this system intended for use in pediatric or adult patients, and what does ‘skeletally mature’ mean in this context?

The Juveno Hip System is intended for skeletally mature patients only, meaning those whose growth plates have closed and bone development is complete. This typically refers to adults, as pediatric patients still undergoing skeletal growth are not considered candidates.

What materials are used in the construction of the Juveno Hip System, and why does that matter?

The system combines metal, ceramic, and polymer components, which provide durability, biocompatibility, and biomechanical compatibility to ensure long-term performance and reduce wear or friction in the hip joint.

How is this device regulated by the FDA, and what does the ‘510(k) clearance’ mean for clinicians?

The Juveno Hip System has received FDA 510(k) clearance (K182705), meaning the manufacturer has demonstrated that it is substantially equivalent to a legally marketed predicate device in terms of safety and effectiveness. Clinicians can rely on this clearance as evidence that the device meets regulatory standards for primary hip replacement procedures.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Juveno Hip System Femoral Stem, b-ONE Primary Acetabular System Cups ..., Juveno Hip System Femoral Stem, B-ONE Primary… - FDA.report, Hip - Novutech

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
B-One Ortho, Corp.

Sources (1)

  • FDA 510(k) K182705 24 fields · synced Oct 6, 2026