OsteoRemedies Hip Spacer System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K253675 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 OsteoRemedies Hip Spacer System is a Prosthesis, Hip, Hemi-, Femoral, Metal, designed for temporary implantation in two-stage revision arthroplasty procedures. It serves as an antibiotic-eluting spacer to manage and treat chronic joint infections, providing joint stability while preventing bacterial colonization during the interim period before definitive reconstruction.
Intended for temporary use only (180 days or less), the system is supplied as a modular set for orthopedic surgeons performing revision hip surgeries. Components are non-sterile and must be sterilized prior to use, with explantation required after the designated period. The device is classified under FDA 510(k) clearance (K253675) and adheres to regulatory standards for orthopedic implants, including MRI safety considerations as outlined in its specifications.
Frequently asked questions
What is the OsteoRemedies Hip Spacer System designed for and how long can it be used temporarily?
The OsteoRemedies Hip Spacer System is designed for temporary implantation during two-stage revision arthroplasty procedures to manage and treat chronic joint infections. It acts as an antibiotic-eluting spacer to prevent bacterial colonization while providing joint stability. It is intended for temporary use only, with a maximum duration of 180 days or less before explantation is required.
Is the OsteoRemedies Hip Spacer System supplied sterile, and what sterilization process is required before use?
The OsteoRemedies Hip Spacer System is supplied as a non-sterile modular set. Since it is not pre-sterilized, the components must be sterilized by the facility prior to use, following appropriate sterilization protocols for orthopedic implants.
What types of sizes or models are available for the OsteoRemedies Hip Spacer System?
The OsteoRemedies Hip Spacer System is available in multiple sizes and models, as indicated by the extensive list of FEI numbers (e.g., 3004748528, 3005913274, etc.) in the regulatory records. These correspond to different configurations or dimensions to accommodate various patient anatomies during revision hip surgeries. Exact sizing details should be referenced in the manufacturer’s technical documentation.
How should the OsteoRemedies Hip Spacer System be stored before use?
Since the system is non-sterile and requires sterilization prior to use, storage should follow standard orthopedic implant protocols. Components should be kept in a clean, dry environment, protected from contamination, and stored according to the manufacturer’s instructions to maintain integrity until sterilization.
What regulatory pathway was followed for FDA clearance of the OsteoRemedies Hip Spacer System?
The OsteoRemedies Hip Spacer System received FDA clearance through a 510(k) submission (K253675) under the Orthopedic (OR) Advisory Committee, with a decision classified as *Substantially Equivalent (SESE)*. The device adheres to FDA standards for orthopedic implants, including MRI safety considerations, as outlined in its specifications.
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 Hip System - Osteo Remedies - Home of REMEDY® HIP, REMEDY® KNEE ..., Osteoremedies - Home of REMEDY® HIP, REMEDY® KNEE, UNITE® AB BONE CEMENT, OsteoRemedies Hip Spacer System (K192995) — 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 | K253675 | Class II | Active |
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Manufacturer
- Manufacturer
- Osteoremedies, Llc
Sources (1)
- FDA 510(k) K253675 24 fields · synced Sep 19, 2026