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Shp Hip System-Femoral Components/Acetabular Components/Modular Heads/Centraliz…

FDA 510(k)

Class II (US FDA 510(k))

510(k) K960984

by Biomet, Inc.

Identifiers

510(k) Number
K960984 FDA 510(k)
FDA Product Code
JDI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3350 FDA 510(k)
Regulation Number
888.3350 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The SHP Hip System comprises modular hip arthroplasty components, including femoral stems, acetabular cups, modular heads, and centralizers. Designed as a cemented hip prosthesis, it features an anatomic cobalt-chromium alloy femoral stem with a proximally roughened surface for improved cement adherence. The acetabular component is constructed from all-polyethylene, with pegs to ensure a uniform cement mantle. Modular heads allow for customization of head size and neck length, enhancing surgical flexibility.

This system is intended for use in total hip arthroplasty procedures, supplied sterile for single-use. Components are engineered with Numerical Shape Optimization (NSO) based on 300 cadaver femurs to optimize fit and function. The femoral stem includes PMMA spacers to aid placement, and all components are designed for MRI-unsafe use. The device holds an FDA 510(k) clearance under product code JDI, with a traditional review pathway and orthopedic advisory committee oversight.

Frequently asked questions

What is the SHP Hip System used for?

The SHP Hip System is designed specifically for total hip arthroplasty procedures, serving as a cemented hip prosthesis. Its modular components—including femoral stems, acetabular cups, modular heads, and centralizers—allow surgeons to customize fit and alignment, improving outcomes for patients requiring hip replacement surgery.

How is the SHP Hip System supplied, and is it reusable?

The SHP Hip System is supplied sterile and intended for single-use only. This ensures patient safety by preventing cross-contamination and maintaining sterility throughout the surgical procedure. Reuse is not recommended or supported by the manufacturer.

What materials are used in the SHP Hip System, and are they MRI-safe?

The femoral stem is made from cobalt-chromium alloy with a proximally roughened surface for better cement adherence, while the acetabular component is constructed from all-polyethylene with pegs for uniform cement distribution. These materials are not MRI-safe, so patients with this system should avoid MRI scans.

How does the modularity of the SHP Hip System enhance surgical flexibility?

The modular heads and centralizers in the SHP Hip System allow surgeons to adjust head size and neck length intraoperatively, tailoring the prosthesis to the patient’s anatomy. This customization helps optimize joint mechanics, reduce stress on surrounding tissues, and improve long-term stability.

What regulatory pathway was followed for the SHP Hip System’s FDA clearance?

The SHP Hip System received FDA 510(k) clearance under product code JDI through a traditional review pathway, with oversight from the Orthopedic (OR) Advisory Committee. The submission was deemed substantially equivalent to a predicate device, ensuring compliance with regulatory standards for hip arthroplasty implants.

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: Shp Hip System-femoral Components/Acetabular Components/Modular Heads ..., PDF K960984 Shp Hip System-femoral Components/Acetabular Components/Modular ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Biomet, Inc.

Sources (1)

  • FDA 510(k) K960984 24 fields · synced Oct 1, 2026