Identifiers
- 510(k) Number
- K173967 FDA 510(k)
- FDA Product Code
- KWL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3360 FDA 510(k)
- Regulation Number
- 888.3360 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Remedy Acetabular Cup is a prosthesis, hip, hemi-, femoral, metal device intended for temporary use as a joint replacement. It is made of fully formed polymethylmethacrylate (PMMA), which is radio-opaque and contains antibiotic. The device is designed for use in two-stage infection revision arthroplasty procedures.
The Remedy Acetabular Cup is a sterile, single-use device supplied for temporary implantation with a maximum duration of 180 days. It is used in combination with the Remedy® Modular Head Small 46mm and is indicated for hip joint applications. The device has received FDA 510(k) clearance under K173967 and is classified as a Class II medical device.
Frequently asked questions
What is the Remedy Acetabular Cup used for?
The Remedy Acetabular Cup is intended for temporary use as a joint replacement in hip joint applications, specifically designed for two-stage infection revision arthroplasty procedures. It is used in combination with the Remedy® Modular Head Small 46mm to provide antibiotic-loaded, radio-opaque support during the interim phase of treatment.
Is the Remedy Acetabular Cup sterile and single-use?
Yes, the Remedy Acetabular Cup is supplied as a sterile, single-use device. It is designed for temporary implantation with a maximum duration of 180 days and must not be reused after removal to prevent infection risk and ensure device integrity.
What material is the Remedy Acetabular Cup made of and what are its key properties?
The device is made of fully formed polymethylmethacrylate (PMMA), which is radio-opaque and contains antibiotic. This composition allows for radiographic visibility and localized antibiotic delivery to help manage infection during the temporary implantation period.
What regulatory clearance does the Remedy Acetabular Cup have?
The Remedy Acetabular Cup has received FDA 510(k) clearance under submission number K173967 and is classified as a Class II medical device. It was determined to be substantially equivalent to a predicate device through a traditional 510(k) pathway.
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: Remedy Cup System - Osteo Remedies - Home of REMEDY® HIP, REMEDY® KNEE ..., Osteoremedies - Home of REMEDY® HIP, REMEDY® KNEE, UNITE® AB BONE CEMENT, PDF OsteoRemedies, LLC ℅ Hollace Saas Rhodes Vice President, Orthopedic ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K173967 | Class II | Active |
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Manufacturer
- Manufacturer
- Osteoremedies, Llc
Sources (1)
- FDA 510(k) K173967 24 fields · synced Sep 28, 2026