DePuy Actis DuoFix Hip Prosthesis
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K160907 FDA 510(k)
- FDA Product Code
- MEH 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 DePuy Actis DuoFix Hip Prosthesis is a femoral hip stem used in total hip arthroplasty or hemi-arthroplasty. It is a line extension adding a smaller size (Size 0) to the existing product line.
The device is implanted by an orthopedic surgeon to replace the femoral head/neck or the entire hip. It received FDA 510(k) clearance under K160907 and is classified under product code MEH.
Frequently asked questions
What is the DePuy Actis DuoFix Hip Prosthesis used for?
The DePuy Actis DuoFix Hip Prosthesis is a femoral hip stem implanted by an orthopedic surgeon to replace the femoral head/neck or the entire hip joint in total hip arthroplasty or hemi-arthroplasty procedures.
How is the DePuy Actis DuoFix Hip Prosthesis supplied and what sizes are available?
The device is supplied as a femoral hip stem and includes a Size 0 extension to the existing product line, offering a smaller size option for patients requiring reduced prosthesis dimensions.
Is the DePuy Actis DuoFix Hip Prosthesis sterile and intended for single use?
Yes, the DePuy Actis DuoFix Hip Prosthesis is provided sterile and is intended for single-use implantation during hip arthroplasty surgery, as is standard for permanent orthopedic implants.
What regulatory pathway was used for the DePuy Actis DuoFix Hip Prosthesis?
The DePuy Actis DuoFix Hip Prosthesis received FDA 510(k) clearance under submission number K160907, demonstrating substantial equivalence to a legally marketed 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: ACTIS Total Hip Solutions | Products | DePuy Synthes, Browse All Depuy Synthes Products | DePuy Synthes, DePuy Actis DuoFix Hip Prosthesis (K160907) — FDA 510(k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K160907 | Class II | Active |
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Manufacturer
- Manufacturer
- Depuy (ireland)
- FDA Applicant
- Depuy(Ireland)
Sources (1)
- FDA 510(k) K160907 24 fields · synced Sep 23, 2026