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StaXx XD System

by Spine Wave, Inc. 3 variants

510(k) K142996

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 · Traditional NumberK142996 Date19 Feb 2015ClearedStatusActive

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  • Withdrawn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)

Full name
StaXx(R) XD System
510(k) Number
FDA Product Code
MQP
Device Class
Class II
Regulation
21 CFR Part 888.3060
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 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 XD System is an expandable PEEK spacer designed for controlled in situ distraction in 1 mm increments. It features a low-profile, expandable design that allows for a significantly smaller working channel compared to standard monolithic implants, potentially reducing bone removal and nerve retraction.

The device is easily expanded in situ with the squeeze of a surgical gun trigger, providing optimal distraction and precise implant fit. It is supplied as a single-use device and is intended for use in lumbar interbody distraction and vertebral body replacement. The system has received FDA 510(k) clearance with K number K142996.

Other devices from Spine Wave, Inc.

See all devices from Spine Wave, Inc. →

Questions

AI-generated answers, 6 Oct 2026

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

  • What is the StaXx XD System used for?

    The StaXx XD System is an expandable PEEK spacer designed for controlled in situ distraction in 1mm increments, intended for use in lumbar interbody distraction and vertebral body replacement procedures.

  • How is the StaXx XD System expanded during surgery?

    The device features a low-profile, expandable design that can be easily expanded in situ with the squeeze of a surgical gun trigger, providing optimal distraction and precise implant fit.

  • Is the StaXx XD System reusable or single-use?

    The StaXx XD System is supplied as a single-use device and should not be reused on multiple patients to ensure safety and performance.

  • What regulatory approval has the StaXx XD System received?

    The system has received FDA 510(k) clearance with K number K142996, classified as substantially equivalent to predicate devices in the orthopedic product code category MQP.