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Crossfuse II Coronal Taper, Crossfuse II Hyperlordotic

by Pioneer Surgical Technology, Inc.

510(k) K133455

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK133455 Date27 Mar 2014ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1916-2015 FDA Class II initiated 21 May 2015

    Three lots of the Bullet -Tip VBR 13mm x 32 mm implants are mislabeled with a light green colored label, used for 16 mm trial instead of a lime green label, used for a 13 mm trial.

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  • Withdrawn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, 1 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 Crossfuse II Coronal Taper and Crossfuse II Hyperlordotic are intervertebral fusion devices with bone graft for lumbar use. These devices are designed to facilitate spinal fusion in the lumbar region.

The devices are supplied by Pioneer Surgical Technology, Inc. and are classified under product code MAX. They received FDA 510(k) clearance on March 27, 2014, with a decision of substantially equivalent. The devices are regulated under 21 CFR 888.3080 for prosthetic devices.

Other devices from Pioneer Surgical Technology, Inc.

See all devices from Pioneer Surgical Technology, Inc. →

Questions

AI-generated answers, 1 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 are the Crossfuse II Coronal Taper and Hyperlordotic devices used for?

    These are intervertebral fusion devices with bone graft designed specifically for lumbar spinal fusion procedures. They facilitate the fusion process in the lumbar region of the spine.

  • How are the Crossfuse II devices supplied?

    The Crossfuse II Coronal Taper and Crossfuse II Hyperlordotic devices are supplied by Pioneer Surgical Technology, Inc. They are classified under product code MAX and are designed for single-use in lumbar fusion procedures.

  • What regulatory status do these devices have?

    The Crossfuse II devices received FDA 510(k) clearance on March 27, 2014, with a determination of substantially equivalent. They are regulated under 21 CFR 888.3080 for prosthetic devices.

  • Are there different models of the Crossfuse II device available?

    Yes, there are two models: the Crossfuse II Coronal Taper and the Crossfuse II Hyperlordotic. Both are intervertebral fusion devices with bone graft for lumbar use, but they have different designs to accommodate various surgical needs.