Impulse Interbody Fusion System
510(k) K201287
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK201287 | Date22 Dec 2020 | 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- Withdrawn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
- MAX
- Device class
- Class II
- Regulation
- 21 CFR Part 888.3080
- Advisory committee
- Orthopedic
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Impulse Interbody Fusion System is an interbody fusion device designed for spinal fusion procedures. It is intended for use in skeletally mature patients with degenerative disc disease of the lumbar spine, including up to Grade 1 spondylolisthesis at one or two contiguous levels from L2 to S1. The system includes additively manufactured titanium interbody spacers with varying lengths, widths, heights, and endplate curvatures, including neutral, lordotic, and anatomic shapes. This device is classified under the FDA’s orthopedic category and is intended for posterior and transforaminal lumbar fusion approaches.
The Impulse Interbody Fusion System is supplied as a sterile, single-use device and is regulated under the FDA’s 510(k) clearance process (K201287). It is intended for surgical use in controlled hospital or clinical settings, where it is implanted to stabilize and promote fusion between vertebrae. The system’s titanium construction and customizable geometries are tailored to match anatomical requirements. Storage and handling must comply with sterile medical device protocols to ensure integrity prior to use.
Other devices from Degen Medical
Questions
AI-generated answers, 1 Oct 2026
What is the Impulse Interbody Fusion System used for?
The Impulse Interbody Fusion System is designed for spinal fusion in skeletally mature patients with degenerative disc disease in the lumbar spine, including cases with up to Grade 1 spondylolisthesis at one or two contiguous levels from L2 to S1. It is intended to stabilize vertebrae and promote fusion through posterior or transforaminal lumbar approaches.
How is the Impulse Interbody Fusion System supplied and prepared for use?
The system is supplied as a sterile, single-use device, ensuring it meets surgical-grade cleanliness standards. It must be handled and stored according to sterile medical device protocols to maintain its integrity before implantation in a controlled hospital or clinical setting.
What materials and customization options are available in the Impulse Interbody Fusion System?
The system features additively manufactured titanium interbody spacers with varying lengths, widths, and heights. It also includes multiple endplate curvatures—neutral, lordotic, and anatomic—to match specific anatomical requirements, enhancing fit and fusion outcomes.
Is the Impulse Interbody Fusion System reusable or intended for single-use?
The Impulse Interbody Fusion System is explicitly designed for single-use only. Reuse is not recommended or supported, as it could compromise sterility and structural integrity, potentially leading to adverse clinical outcomes.
Where and how should the Impulse Interbody Fusion System be stored?
The device must be stored in its original packaging to preserve sterility and prevent contamination. Storage should comply with standard sterile medical device protocols, typically in a clean, dry environment away from direct sunlight or extreme temperatures until ready for surgical use.