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Tritanium PL Cage

by Stryker

510(k) K152304

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 NumberK152304 Date19 Nov 2015ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0605-2019 FDA Class II initiated 28 Nov 2018

    The surgical technique is being updated to caution against misuse due to reports of cage fractures occurring intra-operatively and post-operatively.

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  • Withdrawn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, 27 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 Tritanium PL Cage is a hollow, rectangular implant designed for posterior lumbar interbody procedures. It features a configuration of both solid and porous structures created using additive manufacturing technology.

This device is available in a variety of widths, lengths, heights, and lordotic angles to accommodate different patient anatomies. It has received FDA 510k clearance.

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