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TirboLOX-L Lumbar IBFD

FDA 510(k)

Class II (US FDA 510(k))

510(k) K180990

by Captiva Spine, Inc.

Identifiers

510(k) Number
K180990 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 TirboLOX-L Lumbar IBFD is an Intervertebral Fusion Device With Bone Graft, Lumbar, designed for spinal stabilization. It is a titanium lordotic lumbar cage intended to facilitate fusion at one or two contiguous lumbar levels (L2–S1) in skeletally mature patients with degenerative disc disease.

This device is supplied as a single-use, sterile titanium cage measuring 9.5 mm (W) × 25 mm (L) × 8 mm (H). It is classified under FDA product code MAX and has received FDA 510(k) clearance under the Traditional pathway, with a decision date of August 13, 2018. Storage and handling must comply with sterile medical device protocols.

Frequently asked questions

What is the primary purpose of the TirboLOX-L Lumbar IBFD in spinal surgery?

The TirboLOX-L Lumbar IBFD is designed specifically for spinal stabilization at one or two adjacent lumbar levels (ranging from L2 to S1) in skeletally mature patients suffering from degenerative disc disease. It acts as a titanium cage to facilitate intervertebral fusion, helping restore structural integrity to the spine while promoting bone growth between vertebrae.

Is the TirboLOX-L Lumbar IBFD intended for single-use or can it be reused?

The TirboLOX-L Lumbar IBFD is explicitly supplied as a single-use device. This is a standard practice for sterile titanium implants to ensure patient safety and prevent cross-contamination, so it should not be reused after initial implantation.

What dimensions does the TirboLOX-L Lumbar IBFD have, and how does this affect its application?

The device measures 9.5 mm in width, 25 mm in length, and 8 mm in height, making it a compact titanium cage tailored for lumbar fusion procedures. These dimensions are optimized for placement between contiguous lumbar vertebrae (L2–S1) to provide lordotic support while maintaining compatibility with standard surgical approaches.

How should the TirboLOX-L Lumbar IBFD be stored, and why is this important?

The device must be stored and handled according to sterile medical device protocols, as it is supplied in a sterile condition. Proper storage ensures sterility is maintained until use, reducing the risk of infection and preserving the integrity of the titanium cage for safe implantation during surgery.

What regulatory pathway was followed for FDA clearance of the TirboLOX-L Lumbar IBFD, and what does this mean for clinicians?

The TirboLOX-L Lumbar IBFD received FDA clearance through the Traditional 510(k) pathway, determined to be *substantially equivalent* to a predicate device. This means the FDA reviewed it against existing spinal fusion technologies and confirmed its safety and effectiveness for the specified lumbar application (L2–S1) in degenerative disc disease cases, providing assurance of its regulatory compliance.

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: TirboLOX-L Lumbar IBFD (K180990) — FDA 510 (k) | Innolitics, K180990 - TirboLOX-L Lumbar IBFD | FDA 510 (k), AccessGUDID - DEVICE: TirboLOX-L Lumbar IBFD (M7391916925080), AccessGUDID - DEVICE: TirboLOX-L Lumbar IBFD (M7391930932140)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Captiva Spine, Inc.

Sources (1)

  • FDA 510(k) K180990 24 fields · synced Sep 19, 2026