Identifiers
- 510(k) Number
- K041583 FDA 510(k)
- FDA Product Code
- JDK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.3300 FDA 510(k)
- Regulation Number
- 878.3300 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESU FDA 510(k)
The PEEK Cement Restrictor X-Box is a Class II medical device classified as a hip prosthesis cement restrictor, intended for use in orthopedic surgeries involving the femoral canal and tibial canal during hip stem and total knee replacement procedures. It is designed to restrict the flow of bone cement within the medullary canal to improve fixation and containment.
The device is manufactured by Innovasis, Inc. and is supplied as a single-use, sterile implantable device. It is constructed from PEEK-OPTIMA material and is intended for use in a surgical setting under sterile conditions. The device has received FDA 510(k) clearance under K041583 and is regulated under product code JDK and regulation number 878.3300.
Frequently asked questions
What surgical procedures is the PEEK Cement Restrictor X-Box intended for?
It is designed for orthopedic surgeries that involve the femoral canal and tibial canal, specifically hip stem implantation and total knee replacement. By restricting cement flow, it helps achieve better fixation of the prosthetic components.
How is the device supplied and what are its sterility requirements?
The restrictor is provided as a single‑use, sterile implantable unit. It must be opened only in a sterile surgical environment and used once per patient to maintain the required aseptic conditions.
What material is the restrictor made from and why is it chosen?
It is constructed from PEEK‑OPTIMA, a high‑performance polymer known for its biocompatibility, radiolucency, and mechanical strength. These properties allow the device to withstand surgical handling while not interfering with imaging.
Under which regulatory pathway was the device cleared?
The PEEK Cement Restrictor X-Box received FDA 510(k) clearance (K041583) through the traditional clearance type, classified as a Class II hip prosthesis cement restrictor under product code JDK and regulation 878.3300.
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: PEEK CEMENT RESTRICTOR X-BOX (K041583) — FDA 510(k) | Innolitics, PDF U JU L 2 22004 - Food and Drug Administration, PDF K041583 - Peek Cement Restrictor X-box, Innovasis, K041583 - Prosthesis, Hip, Cement Restrictor FDA 510 (k) APPLICATION ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K041583 | Class II | Active |
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Manufacturer
- Manufacturer
- Innovasis, Inc.
Sources (1)
- FDA 510(k) K041583 24 fields · synced Oct 1, 2026