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StaXx IBL System

by Spine Wave, Inc. 2 variants

510(k) K132719

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK132719 Date4 Oct 2013ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

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, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The StaXx IBL System is an expandable interbody fusion device designed for spinal fusion procedures. It is classified as an intervertebral body fusion implant, providing controlled distraction in situ to facilitate bone graft integration and promote fusion within the intervertebral space.

This device is supplied as a low-profile, expandable implant made from PEEK, available in sizes starting at 9 mm with 1 mm increments. It is intended for use in skeletally mature patients with degenerative disc disease of the lumbar spine at one or two contiguous levels (L2–L5). The system is cleared by the FDA under 510(k) classification, with a special review designation, and is intended for single-use.

Other devices from Spine Wave, Inc.

See all devices from Spine Wave, Inc. →

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of patients is the StaXx IBL System designed for, and what spinal conditions does it address?

    The StaXx IBL System is designed for skeletally mature patients with degenerative disc disease specifically in the lumbar spine. It is intended for use at one or two contiguous levels between L2 and L5, providing controlled distraction to help facilitate bone graft integration and promote spinal fusion within the intervertebral space.

  • Is the StaXx IBL System reusable or intended for single-use, and what material is it made from?

    The StaXx IBL System is explicitly cleared for single-use only. It is constructed from PEEK (polyether ether ketone), a biocompatible polymer commonly used in spinal implants for its strength and radiolucency.

  • What size options are available for the StaXx IBL System, and how does the sizing work?

    The system is available in low-profile, expandable sizes starting at 9 mm, with increments of 1 mm up from there. The expandable design allows for controlled distraction in situ, accommodating varying intervertebral space dimensions during surgery.

  • How is the StaXx IBL System supplied, and are there any special handling requirements for sterility?

    The StaXx IBL System is supplied as a sterile, single-use device. Since it is intended for surgical implantation, it must be handled under sterile conditions to maintain its integrity and prevent contamination before use.

  • What regulatory pathway was followed for FDA clearance of the StaXx IBL System, and what does that mean for its use?

    The StaXx IBL System received FDA 510(k) clearance under a Special Review designation with a determination of Substantially Equivalent (SESE) to a predicate device. This means it has been evaluated by the FDA’s Orthopedic (OR) Advisory Committee and is legally marketed in the U.S. for its intended use in spinal fusion procedures.