Vitality Hip System Model#420
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K070050 FDA 510(k)
- FDA Product Code
- LPH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3358 FDA 510(k)
- Regulation Number
- 888.3358 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Vitality Hip System Model#420 is a modular hip prosthesis system consisting of stems, cups, liners, and heads designed for total hip replacement or hemi-arthroplasty procedures. It is classified as a Class 2 orthopedic device with product code LPH.
The device is implanted by orthopedic surgeons in clinical or hospital settings. It received FDA 510(k) clearance (K070050) through the traditional pathway on May 23, 2007, following a 139-day review, and is substantially equivalent to a predicate device.
Frequently asked questions
What is the Vitality Hip System Model#420 used for?
The Vitality Hip System Model#420 is designed for total hip replacement or hemi-arthroplasty procedures, providing modular components including stems, cups, liners, and heads that are implanted by orthopedic surgeons in clinical or hospital settings to restore hip joint function.
How is the Vitality Hip System Model#420 supplied and is it sterile?
The device data does not specify whether the Vitality Hip System Model#420 is supplied sterile or non-sterile, or details about its packaging and sterilization method; this information must be obtained from the manufacturer's labeling or instructions for use.
Is the Vitality Hip System Model#420 intended for single use or reuse?
As an implantable prosthesis, the Vitality Hip System Model#420 is intended for single-patient use and permanent implantation; it is not designed to be removed, reprocessed, or reused in another patient after explantation.
What sizes or models are available for the Vitality Hip System Model#420?
The device data provided does not list specific sizes, dimensions, or available configurations (such as stem lengths, cup diameters, or head sizes) for the Vitality Hip System Model#420; these details are typically found in the manufacturer's product catalog or surgical technique guide.
What regulatory pathway was used for the Vitality Hip System Model#420?
The Vitality Hip System Model#420 received FDA 510(k) clearance (K070050) through the traditional pathway on May 23, 2007, following a 139-day review, and was determined to be substantially equivalent to a predicate device.
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: K070050 - VITALITY HIP SYSTEM MODEL#420 | FDA 510 (k), VITALITY HIP SYSTEM MODEL#420 (K070050) — FDA 510(k) | Innolitics, VITALITY HIP SYSTEM MODEL#420 by ENCORE MEDICAL, L.P. | FDA 510 (k) Summary
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K070050 | Class II | Active |
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Manufacturer
- Manufacturer
- Encore Medical L.P.
Sources (1)
- FDA 510(k) K070050 24 fields · synced Sep 21, 2026