Dynesys Top-Loading Spinal System
by Zimmer Spine, Inc. 3 variants
510(k) K133164
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK133164 | Date16 Jan 2014 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- NQP
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3070
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Dynesys Top-Loading Spinal System is a posterior metal/polymer spinal fusion device designed for dynamic stabilization of the spine. It provides controlled motion to maintain spinal alignment while facilitating the biological fusion process, using non-rigid materials to preserve natural anatomical structures.
This system is intended for use in orthopedic surgical settings and is supplied as a reusable surgical implant. It is classified as a Class II device under FDA regulations (21 CFR 888.3070) and has received FDA 510(k) clearance (K133164). The system includes multiple component references for various spinal applications, with sterility and MRI safety considerations addressed in the accompanying instructions for use.
Other devices from Zimmer Spine, Inc.
Questions
AI-generated answers, 19 Sep 2026
What types of spinal procedures is the Dynesys Top-Loading Spinal System designed to support, and how does it differ from traditional fusion implants?
The Dynesys Top-Loading Spinal System is specifically designed for posterior dynamic stabilization of the spine, allowing controlled motion to maintain alignment while promoting biological fusion. Unlike traditional rigid fusion implants, it uses non-rigid materials to preserve natural spinal movement, making it suitable for cases where full immobilization isn’t required. It’s intended for orthopedic surgical settings and is classified under Posterior Metal/Polymer Spinal System, Fusion in FDA records.
Is the Dynesys Top-Loading Spinal System reusable or single-use, and what does that mean for surgical workflow?
The system is reusable, meaning it is intended for multiple surgical uses after proper cleaning and sterilization. This design reduces waste and cost per procedure, but it requires adherence to the manufacturer’s reprocessing protocols to ensure safety and sterility between cases. The accompanying Instructions for Use would outline the required sterilization and handling procedures.
What sizes or models are available for the Dynesys Top-Loading Spinal System, and how do I determine the right fit for a patient?
The system includes multiple component references tailored for various spinal applications, as indicated by the extensive list of FEI numbers in FDA records (e.g., 3005677016, 3020282716, etc.). These likely correspond to different sizes, lengths, or configurations for pedicle screws, rods, or connectors. The Instructions for Use would provide sizing guidelines based on anatomical landmarks, patient anatomy, and surgical goals—consulting these documents or a spinal specialist is recommended to select the appropriate model.
Can the Dynesys Top-Loading Spinal System be used with MRI, and how should it be stored to maintain integrity?
MRI safety is addressed in the Instructions for Use, though the data provided does not specify compatibility details. Generally, spinal implants may have restrictions, so verify compatibility with your MRI equipment before use. For storage, the system should be kept in a clean, dry environment away from direct sunlight or extreme temperatures to prevent degradation. Since it’s reusable, ensure proper packaging and sterilization between cases to maintain sterility and functionality.
How was the FDA clearance for the Dynesys Top-Loading Spinal System determined, and what does ‘Substantially Equivalent’ mean in this context?
The system received FDA 510(k) clearance (K133164) under the Traditional 510(k) Review pathway, with a decision labeled as ‘Substantially Equivalent’ (SESE). This means the FDA determined that the device is as safe and effective as a legally marketed predicate device (a previously cleared spinal stabilization system) and does not present new risks. The Orthopedic (OR) Advisory Committee reviewed it under product code NQP, confirming its classification as a Class II device for spinal fusion applications.