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Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200 +1 more model

FDA 510(k)

Class III (US FDA 510(k))

510(k) K092331

by Encore Medical L.P.

Identifiers

510(k) Number
K092331 FDA 510(k)
FDA Product Code
KWA FDA 510(k)
Models / Variants
Djo Surgical Revision Femoral Hip System, Model 428-14/24-140/200 FDA 510(k)
428-00-050/110 FDA 510(k)

Classification

Device Class
Class III FDA 510(k)
Legislation / Framework
21 CFR Part 888.3330 FDA 510(k)
Regulation Number
888.3330 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component), designed for revision hip arthroplasty. It provides a metal, uncemented acetabular component intended to restore hip joint function in patients requiring surgical revision due to implant failure, loosening, or other complications.

The Revision Femoral Hip System is supplied sterile and intended for single-use in orthopedic surgical settings. Components are MRI-unsafe and must be handled with sterile technique. Models include specific reference codes for femoral and acetabular revisions, with sizes tailored for adult anatomy. Authorized under FDA 510(k) clearance (K092331), compliance with regulation 888.3330 applies.

Frequently asked questions

What types of patients is this revision hip system designed for, and why is it considered a semi-constrained design?

This system is specifically designed for patients requiring surgical revision of the hip due to complications like implant failure or loosening. The semi-constrained design provides a balance between stability and flexibility, allowing for better joint motion while reducing the risk of dislocation compared to fully constrained implants. It is intended for uncemented use, meaning it relies on bone ingrowth for stability rather than adhesive fixation.

How is the DJO Surgical Revision Femoral Hip System supplied, and what precautions should be taken during handling?

The system is supplied sterile and intended for single-use in orthopedic surgical settings. Since it is MRI-unsafe, it must be handled with sterile technique to prevent contamination. Preoperative planning should account for its non-magnetic properties, as MRI scans cannot be performed post-implantation.

Are there multiple sizes available, and how are they tailored to adult anatomy?

Yes, the system includes multiple models with specific reference codes (e.g., 428-14/24-140/200; 428-00-050/110) that correspond to different acetabular and femoral components. These sizes are designed to accommodate the anatomical variations of adult patients undergoing revision hip arthroplasty, ensuring a proper fit for optimal function and stability.

What regulatory pathway was followed for FDA clearance, and what does this imply for its safety and effectiveness?

The device was cleared through the FDA’s 510(k) pathway, specifically under the Traditional review process with a determination of Substantially Equivalent (SESE) to a predicate device. This implies that Encore Medical demonstrated the device’s safety and performance met regulatory standards by comparing it to an already-approved, similar product. The clearance type and advisory committee (Orthopedic) indicate it underwent thorough review by experts in the field.

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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Encore Medical L.P.

Sources (1)

  • FDA 510(k) K092331 24 fields · synced Oct 6, 2026