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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 73 of 80

Device	Model / Reference	Registries	Class	Status
Cadence™	10206107	FDA UDI	Class I	Active
Integra® Proximal Humeral Fracture Plate System	HFP0930304LS	FDA UDI	Class II	Active
Titan™	CVR0920076L	FDA UDI	Class I	Active
Integra® Total Foot System	2832153	FDA UDI	Class II	Active
Integra®Ti6®	TC2530	FDA UDI	Class II	Active
Integra® Total Foot System	2830050	FDA UDI	Class II	Active
Titan™	HRA9005218WW	FDA UDI	Class II	Active
MemoFix® Super Elastic Nitinol Staple System	MS-2660	FDA UDI	Class I	Active
Universal 2™ Total Wrist System	263500LF	FDA UDI	Class II	Unknown
Integra® XT	LJU425T	FDA UDI	Class II	Active
KMI Instruments	600730KMI	FDA UDI	Class I	Active
Titan™	T92012012STD	FDA UDI	Class I	Active
Integra®Ti6®	TC4028	FDA UDI	Class II	Active
Universal 2™ Total Wrist System	264520	FDA UDI	Class II	Active
Integra™CMC Interpositional Sizer	CMCSTD	FDA UDI	Class I	Active
Titan™	LNR-0960-192-9R	FDA UDI	Class II	Active
Salto Talaris®	CSA-1030-0004	FDA UDI	Class I	Active
Salto Talaris®	LJU212T	FDA UDI	Class II	Active
MemoFix® Super Elastic Nitinol Staple System	MS-2620	FDA UDI	Class I	Active
Cadence™	10209331	FDA UDI	Class II	Active
Integra® Freedom Wrist Arthroplasty System	348045	FDA UDI	Class I	Active
Titan™	HDL-0926-001	FDA UDI	Class I	Active
Titan™	CSA092005	FDA UDI	Class I	Active
Integra® Total Wrist Fusion System	303314CS	FDA UDI	Class II	Active
Panta® 2	PAN-1010-1428NS	FDA UDI	Class II	Active
Construct ™	CSA-5010-004	FDA UDI	Class I	Unknown
Integra® Freedom Wrist Arthroplasty System	348001	FDA UDI	Class II	Active
Titan™	T92002012STD	FDA UDI	Class I	Active
Integra® Proximal Humeral Fracture Plate System	PSS3520LS	FDA UDI	Class II	Active
Cadence™	10209557	FDA UDI	Class II	Active
Integra® BioMotion® Cannulated Hemi System	HM2300	FDA UDI	Class II	Active
Titan™	TRL096008STD	FDA UDI	Class I	Active
Integra® Titanium Bone Wedge System	TBW-1006-SM8	FDA UDI	Class II	Unknown
Titan™ Reverse Shoulder System	LNR096009R	FDA UDI	Class II	Active
Titan™	CSA092010	FDA UDI	Class I	Active
Integra® BioMotion®	HM3023	FDA UDI	Class I	Active
Viper® Distal Volar Radius Plating System	28135010	FDA UDI	Class II	Unknown
Cadence™	10203007	FDA UDI	Class I	Active
Integra® MemoFix®	MS181414	FDA UDI	Class II	Active
Titan™	CSA-0923-06	FDA UDI	Class I	Active
Salto Talaris®	NBR004T	FDA UDI	Class I	Unknown
Titan™	DGB096008STD	FDA UDI	Class I	Active
Titan™	TRL-0923-010-4216E	FDA UDI	Class I	Active
Panta® 2	PAN-1010-1458NS	FDA UDI	Class II	Active
Titan™	BH0920048002	FDA UDI	Class I	Active
Katalyst™ Bipolar Radial Head System	KATALYSTWANDIMP	FDA UDI	Class II	Unknown
Integra® Total Foot System	2822118	FDA UDI	Class II	Active
BioMotion® Cannulated 1st MPJ Hemi System	HM 3010	FDA UDI	Class I	Active
Titan™	T9200104620C	FDA UDI	Class I	Active
Integra® Total Foot System	2802018	FDA UDI	Class II	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.