ON-X Prosthetic Heart Valve, Model ONXA

FDA PMAFDA UDIEUDAMED

Class III (US FDA PMA)

PMA P000037Ref ONXAE-21Ref ONXM-23Ref ONXAE-19Ref ONXAE-23Ref ONXACE-27/29Ref ONXACE-21Ref ONXANE-25Ref ONXACE-25Ref ONXM-31/33Ref ONXAE-27/29Ref ONXANE-21

by On-X Life Technologies, Inc.

Identity

Trade Name: On-X Prosthetic Heart Valve EUDAMED
ON-X (R) PROSTHETIC HEART VALVE, MODEL ONXA FDA PMA
On-X Aortic Heart Valve with Anatomic Sewing Ring and Extended Holder FDA UDI
On-X Aortic Heart Valve with Conform-X Sewing Ring FDA UDI
On-X Aortic Heart Valve with Standard Sewing Ring and Extended Holder FDA UDI
On-X Aortic Heart Valve with Conform-X Sewing Ring and Extended Holder FDA UDI
On-X Mitral Heart Valve with Standard Sewing Ring FDA UDI
Generic Name: HEART-VALVE, MECHANICAL FDA PMA
Aortic bi-leaflet mechanical heart valve prosthesis FDA UDI
Mitral bi-leaflet mechanical heart valve prosthesis FDA UDI
Device Name: On-X Prosthetic Heart Valve EUDAMED
The On-X® Prosthetic Heart Valve is a bileaflet mechanical heart valve, which consists of an orifice housing and two leaflets. The orifice inflow area has a flared inlet designed to reduce flow turbulence, and the outflow rim consists of leaflet guards designed to protect the leaflets while in the closed position. The leaflets rotate around tabs located within the inner circumference of the orifice ring. In the closed position, each leaflet forms a nominal angle of 40º relative to the plane of the orifice. In the open position, the plane of each leaflet forms a nominal angle of 90deg relative to the plane of the orifice. The leaflets have a travel arc of 50deg to the closed position. The orifice, or housing, is composed of a graphite substrate coated with On-X® Carbon, a pure unalloyed form of pyrolytic carbon. The leaflets consist of On-X® Carbon deposited on a graphite substrate, which is impregnated with 10 weight% tungsten to provide radiopacity. The sewing cuff is constructed of polytetrafluoroethylene (PTFE) fabric mounted on the orifice using titanium retaining rings and 5-0 suture material. This form of sewing cuff attachment to the orifice allows for rotation of the sewing cuff in situ during implantation. Orientation reference marks are provided on the sewing cuff for valve orientation. The On-X® Prosthetic Heart Valve is available in 3 aortic and 2 mitral sewing cuff configurations. Aortic configurations are available in sizes 19, 21, 23, 25, and 27/29 mm. The standard mitral cuff is available in sizes 23, 25, 27/29 and 31/33, while the Conform-X® mitral cuff is available in size 25/33 only. Further detail for the On-X prosthetic heart valve is described in the Summary of Safety and Effectiveness documents for the On-X heart valves: http://www.accessdata.fda.gov/cdrh_docs/pdf/P000037b.pdf (aortic), and http://www.accessdata.fda.gov/cdrh_docs/pdf/P000037S001b.pdf (mitral). FDA UDI
Model / Reference: ONXANE-25 EUDAMEDFDA UDI
ONXACE-27/29 EUDAMEDFDA UDI
ONXAE-23 EUDAMEDFDA UDI
ONXAE-21 EUDAMEDFDA UDI
ONXANE-21 EUDAMEDFDA UDI
ONXAE-27/29 EUDAMEDFDA UDI
ONXM-31/33 EUDAMEDFDA UDI
ONXACE-25 EUDAMEDFDA UDI
ONXAE-19 EUDAMEDFDA UDI
ONXACE-21 EUDAMEDFDA UDI
ONXM-23 EUDAMED
ONXACE-19 FDA UDI
ONXACE-23 FDA UDI
Description: The On-X® Prosthetic Heart Valve is a bileaflet mechanical heart valve, which consists of an orifice housing and two leaflets. The orifice inflow area has a flared inlet designed to reduce flow turbulence, and the outflow rim consists of leaflet guards designed to protect the leaflets while in the closed position. The leaflets rotate around tabs located within the inner circumference of the orifice ring. In the closed position, each leaflet forms a nominal angle of 40º relative to the plane of the orifice. In the open position, the plane of each leaflet forms a nominal angle of 90deg relative to the plane of the orifice. The leaflets have a travel arc of 50deg to the closed position. The orifice, or housing, is composed of a graphite substrate coated with On-X® Carbon, a pure unalloyed form of pyrolytic carbon. The leaflets consist of On-X® Carbon deposited on a graphite substrate, which is impregnated with 10 weight% tungsten to provide radiopacity. The sewing cuff is constructed of polytetrafluoroethylene (PTFE) fabric mounted on the orifice using titanium retaining rings and 5-0 suture material. This form of sewing cuff attachment to the orifice allows for rotation of the sewing cuff in situ during implantation. Orientation reference marks are provided on the sewing cuff for valve orientation. The On-X® Prosthetic Heart Valve is available in 3 aortic and 2 mitral sewing cuff configurations. Aortic configurations are available in sizes 19, 21, 23, 25, and 27/29 mm. The standard mitral cuff is available in sizes 23, 25, 27/29 and 31/33, while the Conform-X® mitral cuff is available in size 25/33 only. Further detail for the On-X prosthetic heart valve is described in the Summary of Safety and Effectiveness documents for the On-X heart valves: http://www.accessdata.fda.gov/cdrh_docs/pdf/P000037b.pdf (aortic), and http://www.accessdata.fda.gov/cdrh_docs/pdf/P000037S001b.pdf (mitral). FDA UDI

Identifiers

Primary DI / UDI-DI: 00851788001679 EUDAMEDFDA UDI
00851788001402 EUDAMEDFDA UDI
00851788001396 EUDAMEDFDA UDI
00851788001440 EUDAMEDFDA UDI
00851788001655 EUDAMEDFDA UDI
00851788001426 EUDAMEDFDA UDI
00851788001297 EUDAMEDFDA UDI
00851788001471 EUDAMEDFDA UDI
00851788001389 EUDAMEDFDA UDI
00851788001464 EUDAMEDFDA UDI
00851788001266 EUDAMED
00851788001488 FDA UDI
00851788001457 FDA UDI
Basic UDI-DI: B-00851788001396 EUDAMED
B-00851788001266 EUDAMED
B-00851788001389 EUDAMED
B-00851788001402 EUDAMED
B-00851788001471 EUDAMED
B-00851788001440 EUDAMED
B-00851788001679 EUDAMED
B-00851788001464 EUDAMED
B-00851788001297 EUDAMED
B-00851788001426 EUDAMED
B-00851788001655 EUDAMED
PMA Number: P000037 FDA PMAFDA UDI
FDA Product Code: LWQ FDA PMAFDA UDI
EMDN Code: P0703020301 BILEAFLET MECHANICAL AORTIC VALVES EUDAMED
P0703020302 BILEAFLET MECHANICAL MITRAL VALVES EUDAMED
GMDN Term: Aortic bi-leaflet mechanical heart valve prosthesis FDA UDI
Mitral bi-leaflet mechanical heart valve prosthesis FDA UDI

Classification

Device Class: Class III EUDAMEDFDA PMAFDA UDI
Market of Registration: Germany EUDAMED
Finland EUDAMED
Advisory Committee: Cardiovascular FDA PMA
FDA Decision: APPR Approved FDA PMA
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 25 Millimeter FDA UDI
Outer Diameter — 29 Millimeter FDA UDI
Outer Diameter — 23 Millimeter FDA UDI
Outer Diameter — 21 Millimeter FDA UDI
Outer Diameter — 19 Millimeter FDA UDI
Outer Diameter — 33 Millimeter FDA UDI

The ON-X Prosthetic Heart Valve, Model ONXA, is a mechanical heart valve designed for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic position. It is manufactured by On-X Life Technologies, Inc. and is intended for use in adult patients requiring valve replacement.

This device is supplied in sizes 19, 21, 23, 25, and 27/29 mm. It is a Class III medical device and is regulated under the FDA PMA (P000037) and MDD authorizations. The valve is intended for single-use and must be implanted by a qualified surgeon in a clinical setting. It is not MRI conditional and should not be used in patients who require MRI.

Frequently asked questions

What is the ON-X Prosthetic Heart Valve used for?

The ON-X Prosthetic Heart Valve, Model ONXA, is used for the replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic position. It is indicated for adult patients who require a mechanical valve replacement.

What sizes are available for the ON-X Prosthetic Heart Valve?

The ON-X Prosthetic Heart Valve, Model ONXA, is available in sizes 19, 21, 23, 25, and 27/29 mm. These sizes are designed to accommodate different patient anatomies and ensure proper fit during implantation.

Is the ON-X Prosthetic Heart Valve MRI safe?

No, the ON-X Prosthetic Heart Valve, Model ONXA, is not MRI conditional. It is not intended for use in patients who require magnetic resonance imaging (MRI) due to the presence of metallic components that may pose a risk in MRI environments.

What regulatory approvals does the ON-X Prosthetic Heart Valve have?

The ON-X Prosthetic Heart Valve, Model ONXA, has received FDA PMA (P000037) and MDD (Medical Device Directive) authorizations. These approvals indicate that the device has met the necessary safety and efficacy standards for use in the United States and other regions under MDD regulations.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: On-X® Aortic Heart Valve - Artivion, On-X Heart Valve Story - - On-X Life Technologies, Inc., This site is Exclusively Sponsored by BRACCO - MRI Safety, On-X prosthetic heart valve design and features. (1) Pure..., On-X® Mitral Heart Valve - Artivion

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_PMA

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDD	—	Class III	Active
FDA PMA	United States	FDA_PMA	P000037	Class III	Active

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: On-X Life Technologies, Inc.

Sources (24)

FDA PMA P000037 24 fields · synced Sep 18, 2026
FDA UDI 66f89c2c-fd67-46b4-88de-3ee514786278 35 fields · synced May 24, 2026
FDA UDI 93f2cb65-75d8-4cda-95e5-a350e60ba29f 35 fields · synced May 29, 2026
FDA UDI ffa6dd1a-8604-4db7-b28e-5394a4680f6d 35 fields · synced May 29, 2026
FDA UDI a1ed2d77-54a1-4b72-bff8-17cf4a7c078e 35 fields · synced May 29, 2026
FDA UDI 5f256471-9715-4362-b234-800b276ce373 35 fields · synced May 30, 2026
FDA UDI e7f9bf0f-11e6-44fb-9933-c9e58379f0bd 35 fields · synced May 30, 2026
FDA UDI d4d79f7e-b23c-4c0c-abc9-6b1ce8e1cf71 35 fields · synced May 30, 2026
FDA UDI 3a3409b4-e74e-4b46-ba1d-d8dc10433ab6 35 fields · synced May 30, 2026
FDA UDI df01c67a-59c8-441d-bf66-628535e03e6e 35 fields · synced May 30, 2026
FDA UDI faf194c1-452a-4b09-9cfb-8de7f2d4e29d 35 fields · synced May 30, 2026
FDA UDI 3a25704b-192f-4980-8aa1-b446ef490115 35 fields · synced May 30, 2026
FDA UDI 108b1d83-306c-4491-b867-fcf0978afe86 35 fields · synced May 30, 2026
EUDAMED 10f967d6-47df-4856-acb0-81f0e324244c 61 fields · synced Jul 9, 2026
EUDAMED b5e5fa23-1166-496d-a0fa-b6097605ec81 61 fields · synced Jul 10, 2026
EUDAMED b9e9ba02-905e-4157-92a3-13ccadc38a26 61 fields · synced Jul 17, 2026
EUDAMED bf73afb4-6d4a-46a2-844c-8fc634abc6c0 61 fields · synced Jul 18, 2026
EUDAMED 58e3c90b-6b80-4b0d-af6b-3fe4b4c1fcc2 61 fields · synced Jul 20, 2026
EUDAMED a1bf5b4b-23bf-4183-8866-773dbc793040 61 fields · synced Jul 21, 2026
EUDAMED 15057ce2-5ba3-43eb-a16d-ebdba26a9e57 61 fields · synced Jul 21, 2026
EUDAMED e04f0321-502c-4806-b69c-00208f67dbcf 61 fields · synced Jul 25, 2026
EUDAMED f5691564-2a3e-47ee-8190-90dacb4e991e 61 fields · synced Jul 26, 2026
EUDAMED c6d5e62d-caf4-40f4-bc2b-2ec725d5c6d0 61 fields · synced Jul 30, 2026
EUDAMED 3d1d7f45-6427-4eb4-a471-5a6ed458ccdb 61 fields · synced Sep 17, 2026