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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)

Page 16 of 80

Device	Model / Reference	Registries	Class	Status
Titan™	HSP-0923-070-007	FDA UDI	Class I	Active
Titan™ Total Shoulder System	MHH09200104015C	FDA UDI	Class II	Unknown
Integra®	503 003545	FDA UDI	Class I	Unknown
Construct® Ankle Fusion Plate System	PSS4532LT	FDA UDI	Class II	Unknown
Integra® Total Foot System	RFOOTCUTIMP	FDA UDI	Class I	Unknown
Cadence™	10209327	FDA UDI	Class II	Active
Integra™Allograft Wedge System	395000	FDA UDI	Class I	Active
TiWedge™	TRL-1006-L09	FDA UDI	Class II	Unknown
Cadence™	10209357	FDA UDI	Class II	Active
Integra® First Choice®	TRL600H160	FDA UDI	Class II	Active
Titan™	T9200105220E	FDA UDI	Class I	Active
Universal 2™ Total Wrist System	263800RT	FDA UDI	Class II	Unknown
Titan™ Reverse Shoulder System	LNR096006R	FDA UDI	Class II	Active
Kompressor™ Compression Screw System	210324	FDA UDI	Class II	Unknown
CAPTURE™ High Torque Screw System	CSS50000034016T	FDA UDI	Class II	Active
Ascension® First Choice® DRUJ System	MUH600S55MWW	FDA UDI	Class II	Active
Salto Talaris®	YKAL14T	FDA UDI	Class I	Unknown
Salto Talaris®	MJU590T	FDA UDI	Class I	Active
Salto Talaris®	LJU265T	FDA UDI	Class II	Active
Construct® Ankle Fusion Plate System	AFPA09LT	FDA UDI	Class II	Unknown
Salto Talaris®	MJU344T	FDA UDI	Class I	Active
Integra® XT	LJU243T	FDA UDI	Class II	Active
Capture™	AI-1010	FDA UDI	Class I	Active
Construct® Ankle Fusion Plate System	PSS4514LT	FDA UDI	Class II	Unknown
Capture™	CSA-5001-004	FDA UDI	Class I	Active
Titan™	PUN-0940-043-000	FDA UDI	Class I	Unknown
Integra®Ti6®	TC4024	FDA UDI	Class II	Active
Salto Talaris®	MJU630T	FDA UDI	Class I	Active
Salto Talaris®	LJU811T	FDA UDI	Class II	Active
Titan™	RMR-0926-01C	FDA UDI	Class I	Active
Integra®Ti6®	FS1006	FDA UDI	Class I	Active
Integra® Ti6® Internal Fixation System	TS3030	FDA UDI	Class II	Active
Titan™	MON-0927-026-07	FDA UDI	Class I	Active
Cadence™	10206210	FDA UDI	Class I	Active
Titan™ Total Shoulder System	MHH-0923-010-4821C	FDA UDI	Class II	Active
Titan™ Total Shoulder System	M9200105022E	FDA UDI	Class II	Active
Titan™ Reverse Shoulder System	LNR096006S	FDA UDI	Class II	Active
KGTI™ Kinetik Great Toe Implant System	015116	FDA UDI	Class I	Unknown
K2™ Hemi Toe Implant System	203415	FDA UDI	Class I	Unknown
Universal 2™ Total Wrist Implant System	268136	FDA UDI	Class I	Active
Integra® External Fixation System	12224121	FDA UDI	Class II	Active
Titan™	LNR-0960-191-9S	FDA UDI	Class II	Active
Integra® XT	LJV171T	FDA UDI	Class II	Active
Integra® Freedom Wrist Arthroplasty System	348075	FDA UDI	Class I	Active
Integra® XT	LJV193T	FDA UDI	Class II	Active
Integra® Freedom Wrist Arthroplasty System	348131E	FDA UDI	Class II	Active
Ascension® First Choice® DRUJ System	MUH600S65LWW	FDA UDI	Class II	Active
Titan™	CSA-0926-05	FDA UDI	Class I	Active
Integra®	TMP-1006-00	FDA UDI	Class I	Unknown
Integra®	LMP-LIDT	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

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.