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Ascension Orthopedics, Inc.

Last updated September 17, 2026

What Ascension Orthopedics, Inc. makes

Ascension Orthopedics, Inc. manufactures orthopedic devices including non-bioabsorbable bone screws, fixed-bearing total ankle prostheses, and various reusable surgical instruments such as instrument trays, ankle prosthesis trials, surgical implant templates, positioning instruments, joint prosthesis implantation kits, and bone-resection orthopedic reamers. They also produce specific implant systems like the Integra MemoFix, Universal 2 Total Wrist Implant System, Salto Talaris, Titan Total Shoulder System, Titan Reverse Shoulder System, Panta 2, Ascension NuGrip, Cadence, Integra, and CAPTURE.

The company's portfolio is regulated under Class I, Class II, Class U, and Unclassified device classifications and is listed in the FDA UDI registry. Ascension Orthopedics, Inc. is based in the US.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What orthopedic devices does Ascension Orthopedics, Inc. manufacture?

Ascension Orthopedics, Inc. produces orthopedic devices including non-bioabsorbable bone screws, fixed-bearing total ankle prostheses, and various reusable surgical instruments such as instrument trays, ankle prosthesis trials, surgical implant templates, positioning instruments, joint prosthesis implantation kits, and bone-resection orthopedic reamers. They also offer specific implant systems like the Integra MemoFix, Universal 2 Total Wrist Implant System, Salto Talaris, Titan Total Shoulder System, Titan Reverse Shoulder System, Panta 2, Ascension NuGrip, Cadence, Integra, and CAPTURE.

Where is Ascension Orthopedics, Inc. based?

Ascension Orthopedics, Inc. is based in the United States. The company operates from a location within the US, where they design, manufacture, and distribute their orthopedic devices and surgical instruments to healthcare facilities and medical professionals.

Which regulatory registries list Ascension Orthopedics, Inc.'s devices?

Ascension Orthopedics, Inc.'s devices are listed in the FDA UDI (Unique Device Identification) registry. This registry tracks medical devices through their unique identifiers, ensuring proper identification and tracking throughout their lifecycle in the healthcare system.

How are Ascension Orthopedics, Inc.'s devices classified?

Ascension Orthopedics, Inc.'s devices are regulated under multiple classifications including Class I, Class II, Class U, and Unclassified. These classifications determine the level of regulatory control applied to each device, with Class I being the lowest risk and Class II requiring more stringent controls, while Class U and Unclassified devices have specific regulatory pathways based on their intended use and potential risks.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: 11101 Metric Blvd, Austin, TX, 78758
Website: —
LinkedIn: —
Facebook: —
Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3002788818
DUNS Number: —

Catalogue (4000)

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Device	Model / Reference	Registries	Class	Status
Integra®	BRH90003	FDA UDI	Class I	Active
Titan™	TL092003003P	FDA UDI	Class I	Active
Integra®Ti6®	TC4018	FDA UDI	Class II	Active
Integra® XT	MJV210T	FDA UDI	Class I	Active
Ascension®	BRH10010P	FDA UDI	Class I	Active
CAPTURE™ High Torque Screw System	CSS50000043028T	FDA UDI	Class II	Active
Titan™	HRA9004415WW	FDA UDI	Class II	Active
K2™ Hemi Toe Implant System	203010	FDA UDI	Class I	Unknown
Capture™	AW1103	FDA UDI	Class I	Active
CAPTURE™ High Torque Screw System	CSS50000025024T	FDA UDI	Class II	Active
Integra® Proximal Humeral Fracture Plate System	PSS2710LS	FDA UDI	Class II	Active
Integra®Ti6®	TC4016	FDA UDI	Class II	Active
Titan™	RGB096008SML	FDA UDI	Class I	Active
K2™ Hemi Toe Implant System	203300	FDA UDI	Class I	Unknown
Integra®Ti6®	TC2508	FDA UDI	Class II	Active
Universal 2™ Total Wrist Implant System	268610	FDA UDI	Class I	Active
Titan™	RMR-0926-00BN	FDA UDI	Class I	Active
Integra®	RET90001	FDA UDI	Class I	Active
Ti6® Internal Fixation System	TT-5000L	FDA UDI	Class I	Active
Integra® Freedom Wrist Arthroplasty System	348131	FDA UDI	Class II	Active
Titan™	MON-0927-026-08	FDA UDI	Class I	Active
Cadence™	10205101	FDA UDI	Class I	Active
Cadence®	CSA-1020-0017	FDA UDI	Class II	Active
Ti6® Internal Fixation System	FS2050	FDA UDI	Class I	Active
Cadence™	10209352	FDA UDI	Class II	Active
Integra® Spider™ Limted Wrist Fusion System	062818	FDA UDI	Class II	Active
Panta® 2	PAN-1010-1645NS	FDA UDI	Class II	Active
Kompressor™ Compression Screw System	217422	FDA UDI	Class I	Unknown
Integra® Total Wrist Fusion System	303452	FDA UDI	Class I	Active
NuGrip® CMC Implant System	CMC-DIS-HAL	FDA UDI	Class I	Active
MBA™ Titanium Subtalar Implant System	050109	FDA UDI	Class II	Active
Cadence™	10203003	FDA UDI	Class I	Active
Panta® 2	PAN-1010-13240	FDA UDI	Class II	Active
Panta® 2	PAN-1010-1710	FDA UDI	Class II	Unknown
Cadence™	10204187	FDA UDI	Class I	Active
Cadence®	CADENCERESECT	FDA UDI	Class I	Unknown
Integra® Total Foot System"	TFSREARFTIMP	FDA UDI	Class II	Unknown
TiWedge™	TRL-1006-L08	FDA UDI	Class II	Unknown
Kompressor™ Compression Screw System	210428	FDA UDI	Class II	Unknown
Integra® XT	LJV315T	FDA UDI	Class II	Active
Integra® Ti6® Internal Fixation System	TS3022	FDA UDI	Class II	Active
Salto Talaris®	MJU012T	FDA UDI	Class I	Active
Integra® XT	MJV311T	FDA UDI	Class I	Active
Cadence™	10209142	FDA UDI	Class II	Active
Titan™	TRL-0923-021-08SML	FDA UDI	Class I	Active
Salto Talaris®	MJU331T	FDA UDI	Class I	Active
Integra® Total Foot System	2830032	FDA UDI	Class II	Active
Titan™	SR0920066001	FDA UDI	Class I	Active
Salto Talaris®	LJU261T	FDA UDI	Class II	Active
Integra®	IMP35001	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

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Importers

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Notified Bodies

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Authorities

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FDA Recalls (9)

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

Ascension Orthopedics, Inc. has 9 recall records, with the earliest initiated on 2002-10-31 and the most recent on 2018-11-16. All recorded recalls have been terminated. The reasons given include incorrectly labeled product lots, cracks in instrument trays, mismatched trial and implant sizes, unreported modifications to the First Choice System, incorrect Instructions for Use packaging, domestic distribution of internationally approved literature, and non-conforming screwdrivers.

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Nov 16, 2018	Z-0794-2019	—	terminated	The product was packaged with the Instructions for Use for a different product (Ascension First Choice DRUJ System Partial Ulnar Head Implant).
Dec 3, 2011	Z-1060-2012	—	terminated	A recent review conducted by Ascension Orthopedics revealed that certain modifications were made to the First Choice System and should have been preceded by a submission of a filing with the FDA.
Jul 12, 2010	Z-0438-2011	—	terminated	Two different product lots were found to be incorrectly labeled and placed into the incorrect box.
Jul 12, 2010	Z-0437-2011	—	terminated	Two different product lots were found to be incorrectly labeled and placed into the incorrect box.
Jun 17, 2009	Z-1524-2010	—	terminated	Trial product was larger than actual implant. Trial product was re-designed to more closely match the implant.
Apr 14, 2009	Z-1524-2009	—	terminated	Screwdriver used with the Ascension Total Foot System not manufactured to specification, resulting in the driver not properly engaging and/or stripping the screws making it difficult to properly seat the screws during surgery.
Oct 2, 2003	Z-1025-04	—	terminated	Cracks in the tray due to excessive use can cause perforations in the outer wrap used to maintain instrument tray sterility.
Oct 31, 2002	Z-0549-03	—	terminated	Brochures approved for international distribution only were distributed domestically.
Oct 31, 2002	Z-0550-03	—	terminated	Literature approved for international distribution only was distributed domestically.