Makoplasty Total Hip Allpication, Rio Standard System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K141989 FDA 510(k)
- FDA Product Code
- OLO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.4560 FDA 510(k)
- Regulation Number
- 882.4560 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Makoplasty Total Hip Application, Rio Standard System is an orthopedic stereotaxic instrument designed for total hip arthroplasty procedures. It provides stereotactic guidance to assist in precise positioning and alignment of hip implants during surgery.
This device is supplied as a single-use system and is intended for use in orthopedic surgeries. It is not sterilized by the manufacturer and must be sterilized prior to use. The system is regulated under FDA 510(k) clearance and is classified as an orthopedic stereotaxic instrument.
Frequently asked questions
What is the Makoplasty Total Hip Rio Standard System used for?
This system is an orthopedic stereotaxic instrument designed to provide stereotactic guidance. It assists surgeons in the precise positioning and alignment of hip implants during total hip arthroplasty procedures.
Is the system sterile when supplied?
No, the system is not sterilized by the manufacturer. It must be sterilized prior to use in the operating room.
How is the system supplied?
The Makoplasty Total Hip Rio Standard System is supplied as a single-use system intended for use in orthopedic surgeries.
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: Makoplasty Total Hip Allpication, Rio Standard System (K141989) — Fda ..., MAKOPLASTY TOTAL HIP ALLPICATION, RIO STANDARD… - FDA.report, Makoplasty Total Hip Application, Rio Standard System (K121064) — Fda ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K141989 | Class II | Active |
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Manufacturer
- Manufacturer
- MAKO Surgical Corp.
- FDA Applicant
- Mako Surgical Corporation
Sources (1)
- FDA 510(k) K141989 24 fields · synced Sep 26, 2026