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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® TruArch®	TA1200	FDA UDI	Class II	Unknown
Titan™	TL092003001P	FDA UDI	Class I	Active
Construct® Ankle Fusion Plate System	PSS6565CT	FDA UDI	Class II	Unknown
Integra™CMC Interpositional Sizer	322110	FDA UDI	Class I	Unknown
Construct® Ankle Fusion Plate System	PSS4540CT	FDA UDI	Class II	Unknown
Integra® Total Foot System	2815002	FDA UDI	Class II	Active
Kompressor™ Compression Screw System	210420	FDA UDI	Class II	Unknown
Construct® Ankle Fusion Plate System	PSS4518LT	FDA UDI	Class II	Unknown
Salto Talaris®	LJU222T	FDA UDI	Class II	Active
Titan™	CSA-0923-08	FDA UDI	Class I	Active
Construct® Ankle Fusion Plate System	PSS6555LT	FDA UDI	Class II	Unknown
Universal 2™ Total Wrist System	262302	FDA UDI	Class II	Active
Titan™	T92002010LRG	FDA UDI	Class I	Active
Viper® Distal Volar Radius Plating System	28006602	FDA UDI	Class II	Unknown
Viper® Distal Volar Radius Plating System	28006601	FDA UDI	Class II	Unknown
Titan™ Total Shoulder System	SEM092002514	FDA UDI	Class II	Active
Integra® Proximal Humeral Fracture Plate System	PSS3515LS	FDA UDI	Class II	Active
Salto Talaris®	MJU353T	FDA UDI	Class I	Active
Kompressor™ Compression Screw System	210416	FDA UDI	Class II	Unknown
Titan™	T95002510165	FDA UDI	Class I	Active
Titan™	CSA092022	FDA UDI	Class I	Active
Ascension Ankle Fusion Plate System	K100176	FDA 510(k)	Class II	Active
Ascension Total Plate System	K100502	FDA 510(k)	Class II	Active
Integra Salto Total Ankle System	K182878	FDA 510(k)	Class II	Active
Ascension Pyrocarbon Lunate	K080997	FDA 510(k)	Class II	Active
Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation System	K162153	FDA 510(k)	Class II	Active
Ascension, Models Cmc-400, 13, Cmc-400-20, Cmc-400-30, Cmc-400-40	K061451	FDA 510(k)	Class II	Active
The Ascension Movement Great Toe System Total Arthroplasty	K102549	FDA 510(k)	U	Active
Integra DigiFuse Cannulated Intramedullary Fusion System	K152527	FDA 510(k)	Class II	Active
Ascension Ankle Fusion Nail System	K100925	FDA 510(k)	Class II	Active
Ascension Silicone Pip	K082231	FDA 510(k)	Class II	Active
Ascension Muh	K052137	FDA 510(k)	Class II	Active
Ascension Atlas Humeral Plating System	K110700	FDA 510(k)	Class II	Active
Integra External Fixation System	K160830	FDA 510(k)	Class II	Active
Integra Total Ankle Replacement System	K151459	FDA 510(k)	Class II	Active
Integra Proximal Humeral Plate System	K121826	FDA 510(k)	Class II	Active
Ascension Sillicone Mcp	K022892	FDA 510(k)	Class II	Active
Ascension Pyrosphere (pcs)	K042690	FDA 510(k)	Class II	Active
Ascension Silicone MCP; Ascension Silicone PIP	K233670	FDA 510(k)	Class II	Active
Ascension Cannulated Screw System	K092440	FDA 510(k)	Class II	Active
Ascension Pyrohemisphere, Models Phs-440-10, Phs-440-20, Phs-440-30, Phs-440-40, Phs-440-50	K041451	FDA 510(k)	Class II	Active
Ascension Metal Great Toe System	K092047	FDA 510(k)	Class II	Active
Ascension Humeral Resurfacing Arthroplasty System	K062861	FDA 510(k)	Class II	Active
Freedom Wrist Arthroplasty System	K233674	FDA 510(k)	Class II	Active
INTEGRA TITAN Modular Total Shoulder System Fin-Lock Glenoid	K152047	FDA 510(k)	Class II	Active
Ascension Humeral Resurfacing Arthoplasty (hra) System Tps/Ha	K071064	FDA 510(k)	Class II	Active
Ascension Pyrosphere Cmc/Tmt	K060560	FDA 510(k)	Class II	Active
TITAN Modular Total Shoulder System	K142413	FDA 510(k)	Class II	Active
Ascension Modular Radial Head	K032686	FDA 510(k)	Class II	Active
Ascension Modular Total Shoulder System	K100448	FDA 510(k)	Class II	Active

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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.