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Ascension Orthopedics, Inc.

US

Last updated September 17, 2026

Information

Country
US
Address
11101 Metric Blvd, Austin, TX, 78758
Website
—
LinkedIn
—
Facebook
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Email
—
Phone
—
PRRC Contact
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EUDAMED SRN
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FDA FEI Number
3002788818
DUNS Number
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Catalogue (4000)

Page 80 of 80
DeviceModel / ReferenceRegistriesClassStatus
Integra® TruArch® TA1200
FDA UDI
Class IIUnknown
Titan™ TL092003001P
FDA UDI
Class IActive
Construct® Ankle Fusion Plate System PSS6565CT
FDA UDI
Class IIUnknown
Integra™CMC Interpositional Sizer 322110
FDA UDI
Class IUnknown
Construct® Ankle Fusion Plate System PSS4540CT
FDA UDI
Class IIUnknown
Integra® Total Foot System 2815002
FDA UDI
Class IIActive
Kompressor™ Compression Screw System 210420
FDA UDI
Class IIUnknown
Construct® Ankle Fusion Plate System PSS4518LT
FDA UDI
Class IIUnknown
Salto Talaris® LJU222T
FDA UDI
Class IIActive
Titan™ CSA-0923-08
FDA UDI
Class IActive
Construct® Ankle Fusion Plate System PSS6555LT
FDA UDI
Class IIUnknown
Universal 2™ Total Wrist System 262302
FDA UDI
Class IIActive
Titan™ T92002010LRG
FDA UDI
Class IActive
Viper® Distal Volar Radius Plating System 28006602
FDA UDI
Class IIUnknown
Viper® Distal Volar Radius Plating System 28006601
FDA UDI
Class IIUnknown
Titan™ Total Shoulder System SEM092002514
FDA UDI
Class IIActive
Integra® Proximal Humeral Fracture Plate System PSS3515LS
FDA UDI
Class IIActive
Salto Talaris® MJU353T
FDA UDI
Class IActive
Kompressor™ Compression Screw System 210416
FDA UDI
Class IIUnknown
Titan™ T95002510165
FDA UDI
Class IActive
Titan™ CSA092022
FDA UDI
Class IActive
Ascension Ankle Fusion Plate System K100176
FDA 510(k)
Class IIActive
Ascension Total Plate System K100502
FDA 510(k)
Class IIActive
Integra Salto Total Ankle System K182878
FDA 510(k)
Class IIActive
Ascension Pyrocarbon Lunate K080997
FDA 510(k)
Class IIActive
Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation System K162153
FDA 510(k)
Class IIActive
Ascension, Models Cmc-400, 13, Cmc-400-20, Cmc-400-30, Cmc-400-40 K061451
FDA 510(k)
Class IIActive
The Ascension Movement Great Toe System Total Arthroplasty K102549
FDA 510(k)
UActive
Integra DigiFuse Cannulated Intramedullary Fusion System K152527
FDA 510(k)
Class IIActive
Ascension Ankle Fusion Nail System K100925
FDA 510(k)
Class IIActive
Ascension Silicone Pip K082231
FDA 510(k)
Class IIActive
Ascension Muh K052137
FDA 510(k)
Class IIActive
Ascension Atlas Humeral Plating System K110700
FDA 510(k)
Class IIActive
Integra External Fixation System K160830
FDA 510(k)
Class IIActive
Integra Total Ankle Replacement System K151459
FDA 510(k)
Class IIActive
Integra Proximal Humeral Plate System K121826
FDA 510(k)
Class IIActive
Ascension Sillicone Mcp K022892
FDA 510(k)
Class IIActive
Ascension Pyrosphere (pcs) K042690
FDA 510(k)
Class IIActive
Ascension Silicone MCP; Ascension Silicone PIP K233670
FDA 510(k)
Class IIActive
Ascension Cannulated Screw System K092440
FDA 510(k)
Class IIActive
Ascension Pyrohemisphere, Models Phs-440-10, Phs-440-20, Phs-440-30, Phs-440-40, Phs-440-50 K041451
FDA 510(k)
Class IIActive
Ascension Metal Great Toe System K092047
FDA 510(k)
Class IIActive
Ascension Humeral Resurfacing Arthroplasty System K062861
FDA 510(k)
Class IIActive
Freedom Wrist Arthroplasty System K233674
FDA 510(k)
Class IIActive
INTEGRA TITAN Modular Total Shoulder System Fin-Lock Glenoid K152047
FDA 510(k)
Class IIActive
Ascension Humeral Resurfacing Arthoplasty (hra) System Tps/Ha K071064
FDA 510(k)
Class IIActive
Ascension Pyrosphere Cmc/Tmt K060560
FDA 510(k)
Class IIActive
TITAN Modular Total Shoulder System K142413
FDA 510(k)
Class IIActive
Ascension Modular Radial Head K032686
FDA 510(k)
Class IIActive
Ascension Modular Total Shoulder System K100448
FDA 510(k)
Class IIActive

Related Companies

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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.

DateRecall No.ClassStatusReason
Nov 16, 2018Z-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, 2011Z-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, 2010Z-0438-2011—terminated

Two different product lots were found to be incorrectly labeled and placed into the incorrect box.

Jul 12, 2010Z-0437-2011—terminated

Two different product lots were found to be incorrectly labeled and placed into the incorrect box.

Jun 17, 2009Z-1524-2010—terminated

Trial product was larger than actual implant. Trial product was re-designed to more closely match the implant.

Apr 14, 2009Z-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, 2003Z-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, 2002Z-0549-03—terminated

Brochures approved for international distribution only were distributed domestically.

Oct 31, 2002Z-0550-03—terminated

Literature approved for international distribution only was distributed domestically.