Data / Medical devices / United States / On-X Life Technologies Inc.

On-X Life Technologies Inc.: FDA-registered device maker in Austin, TX, United States, 1 510(k) clearance and 1 PMA approval

Name: On-X Life Technologies Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

On-X Life Technologies Inc. is registered with the FDA (registration 1649833) in Austin, TX, United States. It lists 14 device types. The FDA files 1 510(k) clearance and 1 PMA approval under its listings, the newest dated June 6, 2014. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 1649833
FEI number: 3001584317
Address: 1300 East anderson Lane Building B, Austin, TX, United States, 78752
Owner or operator: On-X Life Technologies, Inc (10022596)
Roles: Contract manufacturer, Manufacturer, Manufacturer for export, Specification developer
First device listed: October 5, 2007
Registered through: 2026
Brand names listed: Ascension MCP, Ascension NuGrip CMC Implant; Integra, Ascension PIP, Ascension Pyrocarbon Lunate; Integra, Ascension Pyrosphere; Integra, Carbon Modular Radial Head, Chord-X Pre-measured Loops for Mitral Chordal Replacement, Chordal Sizer and more

Devices it lists

Device	Product code	Class	Role	Source
Cardiovascular Surgical Instruments Tray	OFA	1	Manufacturer	accessdata.fda.gov
Finger Semi-Constrained Pyrolytic Carbon Uncemented Prosthesis	NEG	3	Contract manufacturer	accessdata.fda.gov
Heart-Valve, Mechanical	LWQ	3	Manufacturer	accessdata.fda.gov
High Demand, Revision, Semi-Constrained, Pyrolytic Carbon, Uncemented Finger Prosthesis	OMX	f	Contract manufacturer	accessdata.fda.gov
Holder, Heart-Valve, Prosthesis	DTJ	1	Manufacturer	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	1	Manufacturer	accessdata.fda.gov
Instruments, Surgical, Cardiovascular	DWS	1	Manufacturer	accessdata.fda.gov
Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement	PAW	2	Specification developer	accessdata.fda.gov
Probe, Test, Heart-Valve	LXN	1	Manufacturer	accessdata.fda.gov
Prosthesis, Elbow, Hemi-, Radial, Polymer	KWI	2	Manufacturer for export	accessdata.fda.gov
Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented	HSD	2	Manufacturer for export	accessdata.fda.gov
Prosthesis, Wrist, Carpal Lunate	KWN	2	Contract manufacturer	accessdata.fda.gov
Prosthesis, Wrist, Carpal Trapezium	KYI	2	Contract manufacturer	accessdata.fda.gov
Sizer, Heart-Valve, Prosthesis	DTI	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
June 6, 2014	K141060	CHORD-X PRE-MEASURED LOOPS FOR MITRAL CHORDAL REPLACEMENT	PAW	Substantially Equivalent	On-X Life Technologies, Inc.	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
May 30, 2001	P000037	ON-X (R) PROSTHETIC HEART VALVE, MODEL ONXA	LWQ	65	August 4, 2026	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
February 1, 2026	98548	Class II	Ongoing	On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33	Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.	accessdata.fda.gov
December 13, 2016	75951	Class II	Terminated	Chord-X Chordal Sizer is designed to assist in determining the proper length of chordal replacement prostheses to repair the mitral valve and help the surgeon select a preconfigured prosthesis, or configure the correct s	Four issues were uncovered by the recalling firm's CAPA: 1) Burrs were found to be present on Left Housing, Right Housing and Barrel components, 2) Loose plastic particulate was found within sealed primary packages, 3) Loose hair was discovered within four sealed primary packages and 4) Assembly error, wherein Left and Right Housing components were acceptabl	accessdata.fda.gov

Compare with other makers

Updated August 4, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.