CONSTRUX Mini Ti Spacer System

by Orthofix, Inc.

510(k) K203342

CONSTRUX Mini Ti Spacer System is a Class II device made by Orthofix, Inc., cleared under FDA 510(k) K203342 on 18 Mar 2021, active as of 22 Oct 2026. One FDA recall is linked to it.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

This device is named in the recall

Documents

510(k) K203342↗

FDA record

Trust

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK203342	Date18 Mar 2021Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K203342

Recalls

1 recall · 1 ongoing · FDA

- Ongoing Z-0896-2026 FDA Class III initiated 3 Nov 2025
Labeling contains claims that are not consistently present.

Timeline

2 dated events

18 Mar 2021 Cleared FDA 510(k) K203342
3 Nov 2025 Recall initiated FDA recalls Z-0896-2026

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K203342
FDA product code: ODP

Device class: Class II
Regulation: 21 CFR Part 888.3080
Advisory committee: Orthopedic
FDA decision: SESE Substantially Equivalent

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