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Integra® Total Foot System

Ascension Orthopedics, Inc. · Model 2832102 · UDI-DI 10381780119180

HRS HWC Prescription

510(k) clearances

39,163

Adverse events (74 deaths)

287

Recalls

517

Facilities

Description

The Integra Total Foot System open wedge plate is used for fixation for a variety of proximal metatarsal osteotomies. The stem is deepened and tapered for distraction of osteotomy during insertion and solid contact against cortical bone. It contains distal screw holes that are narrowed for an anatomic fit along the distal metatarsal and stems moved proximally on plate to minimize potential interference with proximal joint

Recalls

Date	Firm	Reason
2026-08-18	Wright Medical Technology, Inc.	Screws, intended for use with polyaxial compression plating system intended for foot osteotomies, was manufactured with missing threads on the screwheads, which if used would preve
2026-05-28	Acumed LLC	Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use.
2026-01-23	I.T.S. GmbH	Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
2026-01-23	I.T.S. GmbH	Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
2026-01-23	I.T.S. GmbH	Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
2026-01-23	I.T.S. GmbH	Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
2026-01-23	I.T.S. GmbH	Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
2026-01-23	I.T.S. GmbH	Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
2026-01-23	I.T.S. GmbH	Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
2026-01-23	I.T.S. GmbH	Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.