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Avitus Orthopaedics, Inc

Last updated September 17, 2026

Information

Device	Model / Reference	Registries	Class	Status
DragonWing	AD-5ch-5.2-120	FDA UDI	Class II	Active
Avitus Surgical Tray	ST-01	FDA UDI	Class I	Active
Avitus Bone Harvester	BH-220	FDA UDI	Class II	Active
Avitus Pilot Hole Creator, Disposable - 11mm	PC-100	FDA UDI	Class I	Active
Avitus ® Bone DebriderTM – Ø8mm, 255mm Shaft Length	BH-330	FDA UDI	Class II	Active
Avitus Bone Harvester	BH-210	FDA UDI	Class II	Active
Avitus Bone Harvester	FI-100	FDA UDI	Class II	Active
Avitus Bone Harvester	BH8	FDA UDI	Class II	Active
Avitus Pilot Hole Creator - 11mm	PH11	FDA UDI	Class I	Active
ArchiMIS	AD-1ch-4.0-120	FDA UDI	Class II	Active
Avitus Pilot Hole Creator, Disposable - 8mm	PC-200	FDA UDI	Class I	Active
Avitus Bone Harvester	BH-110	FDA UDI	Class II	Active
Avitus® Precision Autograft Delivery System	K230492	FDA 510(k)	Class II	Active
Avitus Bone Harvester with Filter Insert - 5mm, Avitus Bone Harvester - 5mm, Avitus Bone Harvester with Filter Insert - 8mm, Avitus Filter Insert - 8mm, Avitus Filter Insert - 5mm	K170539	FDA 510(k)	Class II	Active
Avitus(r) Bone Harvester	K210631	FDA 510(k)	Class II	Active
Avitus® DragonWing Large Volume Autograft Delivery System	K231456	FDA 510(k)	Class II	Active
Avitus Bone Harvester	K152474	FDA 510(k)	Class II	Active

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Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Feb 18, 2019	Z-1047-2019	—	terminated	Breach in the sterile barrier pouch may compromise sterility of the device.
Feb 18, 2019	Z-1046-2019	—	terminated	Breach in the sterile barrier pouch may compromise sterility of the device.