Identifiers
- 510(k) Number
- K111553 FDA 510(k)
- FDA Product Code
- MAX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3080 FDA 510(k)
- Regulation Number
- 888.3080 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Lumbar IBF System is an intervertebral body fusion cage designed for lumbar spinal fusion, classified under the Intervertebral Fusion Device With Bone Graft, Lumbar category. These devices are implanted during surgery to stabilize the spine and promote fusion in patients with degenerative disc disease, providing structural support to the lumbar vertebrae.
Implanted in an operating room setting, the system consists of cages manufactured from PEEK Optima LT1, featuring raised surface contours to minimize migration risk. Available in multiple dimensions, the cages are intended for use alongside supplemental spinal fixation systems cleared for lumbar applications. The device holds an FDA 510(k) clearance under the K111553 classification, adhering to Class II special controls for spinal implants.
Frequently asked questions
What is the Lumbar IBF System used for?
The Lumbar IBF System is designed for lumbar spinal fusion surgery. It provides structural support to the lumbar vertebrae and promotes bone fusion in patients with degenerative disc disease. The device is implanted during surgery to stabilize the spine and is intended to be used alongside supplemental spinal fixation systems cleared for lumbar applications.
What material is the Lumbar IBF System made from?
The Lumbar IBF System cages are manufactured from PEEK Optima LT1, a biocompatible polymer chosen for its strength, radiolucency, and resistance to corrosion. This material helps reduce the risk of migration due to its raised surface contours, which improve integration with the surrounding bone.
Is the Lumbar IBF System single-use or reusable?
The Lumbar IBF System is intended for single-use only. Once implanted in a patient, the device becomes part of the body’s internal structure and is not designed for removal or reuse. Single-use devices minimize infection risks and ensure patient safety by preventing cross-contamination between procedures.
What sizes or dimensions are available for the Lumbar IBF System?
The Lumbar IBF System is available in multiple dimensions to accommodate different anatomical requirements. Exact sizes should be referenced in the manufacturer’s technical documentation or surgical guides, as they are tailored to specific lumbar interbody fusion procedures. These variations allow for precise placement and optimal stabilization.
How is sterility maintained for the Lumbar IBF System?
The Lumbar IBF System is supplied in a sterile packaging to ensure safety for surgical use. Sterility is maintained through validated manufacturing processes, including terminal sterilization methods such as gamma irradiation, which are documented in the device’s packaging instructions. Always follow the manufacturer’s guidelines for handling and opening the sterile packaging to prevent contamination.
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: SPINEFRONTIER LUMBAR IBF SYSTEM (K111553) — FDA 510 (k) | Innolitics, K111553 FDA 510 (k) - SPINEFRONTIER LUMBAR IBF SYSTEM, SpineFrontier Lumbar Interbody Fusion Device System
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K111553 | Class II | Active |
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Manufacturer
- Manufacturer
- Spinefrontier, Inc.
Sources (1)
- FDA 510(k) K111553 24 fields · synced Oct 1, 2026