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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® Total Foot System	2835012	FDA UDI	Class II	Active
Universal 2™ Total Wrist Implant System	268104	FDA UDI	Class I	Active
Titan™	CSA-0961-01	FDA UDI	Class I	Active
Integra® Total Foot System	2814004	FDA UDI	Class II	Active
Integra®Ti6®	TH3032	FDA UDI	Class II	Active
Integra® XT	LJV182T	FDA UDI	Class II	Active
MemoFix® Super Elastic Nitinol Staple System	MT-4000	FDA UDI	Class I	Active
KGTI™ Kinetik Great Toe Implant System	015110	FDA UDI	Class I	Unknown
Integra®	12227009	FDA UDI	Class I	Active
Titan™ Total Shoulder System	BOD-0923-021-08SML	FDA UDI	Class II	Active
CAPTURE™ High Torque Screw System	CSS50000025030T	FDA UDI	Class II	Active
Integra®	CDGTFS18	FDA UDI	Class I	Active
Integra®	CSA90002	FDA UDI	Class I	Active
Integra® Total Foot System	2802102	FDA UDI	Class II	Active
CAPTURE™ Screw System	AC3028	FDA UDI	Class II	Active
Integra®	CSA89501	FDA UDI	Class I	Active
Integra®	BRH30020	FDA UDI	Class I	Active
Capture™	AI-3050	FDA UDI	Class I	Active
Viper® Distal Volar Radius Plating System	27142738	FDA UDI	Class II	Unknown
Salto Talaris®	YRAL13T	FDA UDI	Class I	Unknown
Integra® External Fixation System	12224218	FDA UDI	Class II	Active
Integra®Ti6®	TC4012	FDA UDI	Class II	Active
Integra®	BRH30022	FDA UDI	Class I	Active
Integra®	CCR8950121	FDA UDI	Class I	Active
Capture™	AI-3020	FDA UDI	Class I	Active
Titan™	BDG096007401	FDA UDI	Class I	Active
Ascension®	PYROMCPINSTP	FDA UDI	Class II	Unknown
Titan™	T9200104419E	FDA UDI	Class I	Active
CAPTURE™ High Torque Screw System	CSS50000043034T	FDA UDI	Class II	Active
CAPTURE™ Screw System	AC2514	FDA UDI	Class II	Active
Integra®	TRL31024S	FDA UDI	Class II	Active
Integra® XT	MJV273T	FDA UDI	Class I	Active
Integra® NuGrip®	CSA44305	FDA UDI	Class I	Active
Integra®	CSA-1006-05	FDA UDI	Class I	Unknown
Titan™	TL092003000P	FDA UDI	Class I	Active
Titan™ Total Shoulder System	M9200105022C	FDA UDI	Class II	Active
Integra®	CSA00004	FDA UDI	Class I	Active
Integra®	TRL35220L	FDA UDI	Class II	Active
Cadence®	10204270	FDA UDI	Class I	Active
Panta® 2	PAN-1010-1685NS	FDA UDI	Class II	Active
Integra® Freedom Wrist Arthroplasty System	348103	FDA UDI	Class I	Active
Titan™	RR0920057002	FDA UDI	Class I	Active
Titan™	IMP096006601	FDA UDI	Class I	Active
Titan™	SET189D007	FDA UDI	Class I	Active
Capture™	CSA-5001-008	FDA UDI	Class I	Active
Integra® MOVEMENT® Great Toe System	MGT89010PPT	FDA UDI	U	Active
Integra® XT	CSA-1030-0007	FDA UDI	Class I	Active
Integra®	BRH5253P	FDA UDI	Class I	Active
Titan™	R95002514165	FDA UDI	Class I	Active
Titan™	DL0920056001	FDA UDI	Class I	Active

Related Companies

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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.