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Integra® Total Foot System"

Ascension Orthopedics, Inc. · Model FFMFOOTIMP · UDI-DI 10381780064633

HRS HWC Prescription

510(k) clearances

39,163

Adverse events (74 deaths)

287

Recalls

517

Facilities

Description

The Integra Total Foot System is a system containing bone plates and screws designed for use in the skeletally mature foot. The plates and screws are intended to be used for stabilization and fixation of fresh fractures, intra-articular and extra-articular fractures, joint depression and multi-fragmentary fractures. The subject devices can also be used in revision procedures, joint fusion, and in reconstructing the small bones of the feet. Implants are manufactured from Titanium Alloy. . The fore foot and mid foot plates include open wedge plates, universal forefoot plates, MPJ fusion plates, and tarsalis plates. Also included are 2.7mm locking screws.

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.