Companies / Grace Medical

Medical device company profile

Grace Medical

Memphis-based ENT device manufacturer offering middle-ear implants, ventilation tubes and surgical instrumentation, part of Innovia Medical.

Medical Device Manufacturer and DeveloperENT & Airway CareOtology

Headquarters🇺🇸Memphis, Tennessee, United States

Founded1995

Commercial statusCommercially availableCommercial ENT implants, ventilation tubes and surgical instrumentation; an Innovia Medical company.

Employees51–200 ^[13]LinkedIn company-size range · Checked 2026-11-04

Estimated revenueNot confirmed

Official websitewww.gracemedical.com ↗

Company overview

Grace Medical is a Memphis, Tennessee manufacturer of ear, nose and throat devices. Founded in 1995, the company became part of Innovia Medical through an acquisition announced in July 2025. Its business combines proprietary otology products with a broader ENT supply and distribution offering.

The company’s core products include ossicular replacement prostheses for middle-ear reconstruction, stapes prostheses, ventilation tubes and the DragonFly Surgical Drill System. Its implant range includes adjustable ALTO prostheses and nitinol-based designs intended to support implant positioning and coupling.

Grace also supplies specialist instruments and complementary ENT products. President and Chief Operating Officer Mike Crook continued with the business following the acquisition, with responsibility for the strategic direction of Innovia Medical’s ENT division.

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Leadership

2 people

Michael “Mike” CrookPresident & Chief Operating Officer ^[1]

Murray BeardChief Executive Officer ^[1]

Products & regulatory status How does MedTechIndex get this information?

Summary

Grace Medical has FDA 510(k) clearances for selected middle-ear implants, tympanostomy tubes and the DragonFly Surgical Drill System. These decisions apply to the devices and configurations named in the individual records. ^{[2][5][4][3][10]}

An open Class II recall concerns titanium/fluoroplastic stapes piston catalog 409-375, lot 122927. The label specified a 3.75 mm functional length, but the devices measured 4.00 mm. The recall was initiated April 3, 2026, and posted by FDA on June 4, 2026. Customers were instructed to stop use, quarantine affected stock and arrange its return through Grace Medical; this action is specific to the identified product and lot. ^[6]

Regulatory snapshot How to read this snapshot

U.S. FDA

4+
510(k) clearances: —
De Novo grants: —
PMA approvals: 1+
Recall events

Latest recorded source review: 2026-11-04.

Scope: selected product families.

View 1 documented open recall event

Documented open FDA recall events
Recalled product / record	Initiated	Source
Titanium/fluoroplastic stapes piston, catalog 409-375, lot 122927Z-2308-2026	April 3, 2026	^[6]

Commercial portfolio snapshot

Documented commercial product families.

Grace Medical ALTO NyteByte partial ossicular prosthesis — Image: Grace Medical

Ossicular replacement and stapes prostheses

Middle-ear reconstruction implants ↗

Implants used to reconstruct the middle-ear sound-conduction chain, including ALTO adjustable ossicular prostheses and stapes pistons. The image shows an ALTO NyteByte partial prosthesis. ^[10][2][5]

Commercially available