Avanti Orthopaedics Ulnar Shortening System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K211592 FDA 510(k)
- FDA Product Code
- HRS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3030 FDA 510(k)
- Regulation Number
- 888.3030 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Avanti Orthopaedics Ulnar Shortening System is designed for ulnar shortening osteotomy to address clinical problems resulting in ulnar-sided wrist pain. It contains components to surgically shorten the ulna, a bone in the forearm, to alleviate conditions such as ulnar impaction syndrome. The system typically includes plates and screws to stabilize the bone after shortening, helping to reduce wrist pain and improve range of motion.
This system is intended for surgical use in patients with specific wrist pathologies requiring ulnar shortening. It is supplied as a sterile, single-use device and should be stored according to manufacturer instructions. The Avanti Orthopaedics Ulnar Shortening System has FDA 510(k) clearance with product code HRS and is regulated under the traditional clearance pathway.
Frequently asked questions
What is the Avanti Orthopaedics Ulnar Shortening System used for?
The system is designed for ulnar shortening osteotomy to address clinical problems resulting in ulnar-sided wrist pain, specifically for conditions such as ulnar impaction syndrome. It helps reduce wrist pain and improve range of motion by surgically shortening the ulna bone in the forearm.
How is the Avanti Orthopaedics Ulnar Shortening System supplied?
The system is supplied as a sterile, single-use device and should be stored according to the manufacturer's instructions. It includes components such as plates and screws to stabilize the bone after the ulna has been shortened during surgery.
What is the regulatory status of the Avanti Orthopaedics Ulnar Shortening System?
The Avanti Orthopaedics Ulnar Shortening System has FDA 510(k) clearance with product code HRS and is regulated under the traditional clearance pathway. It was received by the FDA on May 24, 2021, and cleared on July 16, 2021.
Is the Avanti Orthopaedics Ulnar Shortening System reusable?
No, the system is supplied as a sterile, single-use device and should not be reused. Each component is designed for one surgical procedure only to ensure patient safety and device integrity.
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: Ulnar Shortening System - Avanti, Avanti Orthopaedics Ulnar Shortening System - Avanti Orthopaedics | FDA ..., Avanti Orthopaedics Ulnar Shortening System (K211592) — FDA 510 (k ..., K211592 FDA 510(k) - Avanti Orthopaedics Ulnar Shortening System
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K211592 | Class II | Active |
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Manufacturer
- Manufacturer
- Avanti Orthopaedics, Inc.
Sources (1)
- FDA 510(k) K211592 24 fields · synced Sep 22, 2026