Instinct Java System
FDA 510(k)Class II (US FDA 510(k))
by Zimmer Spine
Identifiers
- 510(k) Number
- K122592 FDA 510(k)
- FDA Product Code
- MNH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3070 FDA 510(k)
- Regulation Number
- 888.3070 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Instinct Java System is a pedicle screw system designed to treat multiple pathologies in a proven design. The screw fixation utilizes a combination of asymmetrical and dual threads to improve cortical and cancellous bone fixation and resistance to screw pull-out.
The system is designed to treat a wide variety of spinal pathologies with intuitive solutions, offering versatile options to surgeons. It provides low profile implants with high biomechanical strength and is based on optimized design principles. The system is supplied as a sterile device and is intended for single use.
Frequently asked questions
What is the Instinct Java System designed to treat?
The Instinct Java System is designed to treat a wide variety of spinal pathologies with intuitive solutions, offering versatile options to surgeons while providing low profile implants with high biomechanical strength.
How is the Instinct Java System supplied and is it reusable?
The system is supplied as a sterile device and is intended for single use only, ensuring optimal safety and performance for each patient procedure.
What are the key features of the Instinct Java System screws?
The screw fixation utilizes a combination of asymmetrical and dual threads to improve cortical and cancellous bone fixation and resistance to screw pull-out, based on optimized design principles.
What is the regulatory status of the Instinct Java System?
The Instinct Java System has received FDA 510(k) clearance with the K number K122592, determined to be substantially equivalent to predicate devices for spinal fixation.
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: PDF Instinct Java Ins - tehransutures.com, PDF Instinct Java Ins - tehransutures.com, Instinct Java System Surgical Technique - Your everyday spinal fixation ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K122592 | Class II | Active |
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Manufacturer
- Manufacturer
- Zimmer Spine
Sources (1)
- FDA 510(k) K122592 24 fields · synced Sep 22, 2026