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Sign in to claim this brandAscension Orthopedics, Inc.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 11101 Metric Blvd, Austin, TX, 78758
- Website
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- —
- —
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- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3002788818
- DUNS Number
- —
Catalogue (4000)
Page 3 of 80| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ascension® Silicone MCP | SMCP50010WW | FDA UDI | Class II | Active |
| CAPTURE™ High Torque Screw System | CSS50000025032T | FDA UDI | Class II | Active |
| Cadence™ | 10203012 | FDA UDI | Class I | Active |
| Titan™ Total Shoulder System | MHH-0923-010-5019C | FDA UDI | Class II | Active |
| Integra®Ti6® | TH3026 | FDA UDI | Class II | Active |
| Integra® XT | MJV253T | FDA UDI | Class I | Active |
| CAPTURE™ High Torque Screw System | CSS500000170115T | FDA UDI | Class II | Active |
| Integra™Allograft Wedge System | 390010 | FDA UDI | Class I | Active |
| Integra® PyroCarbon | PYROSADINSTP | FDA UDI | Class I | Unknown |
| Cadence™ | 10209559 | FDA UDI | Class II | Active |
| Ascension® NuGrip® | NUG44330S | FDA UDI | Class II | Active |
| Cadence® | 10204274 | FDA UDI | Class I | Active |
| Cadence™ | 10209241 | FDA UDI | Class II | Active |
| CAPTURE™ Screw System | AC4022 | FDA UDI | Class II | Active |
| Salto Talaris® | MJU085T | FDA UDI | Class I | Active |
| Integra®Ti6® | TC3018 | FDA UDI | Class II | Active |
| Movement® | TRL89040PPH | FDA UDI | Class II | Active |
| Integra® | 12224506 | FDA UDI | Class I | Active |
| Integra®Ti6® | TH3030 | FDA UDI | Class II | Active |
| Titan™ Reverse Shoulder System | BBS096021SML | FDA UDI | Class II | Active |
| Ascension® PyroSphere | PCS43030WW | FDA UDI | Class II | Active |
| Universal 2™ Total Wrist System | 263300RT | FDA UDI | Class II | Active |
| Ascension® First Choice® DRUJ System | DRUJ6101955WW | FDA UDI | Class II | Active |
| CAPTURE™ High Torque Screw System | CSS50000017090T | FDA UDI | Class II | Active |
| Cadence™ | 10204202 | FDA UDI | Class I | Active |
| NuGrip® CMC Implant System | CUT443L | FDA UDI | Class I | Active |
| Construct® Ankle Fusion Plate System | PSS6580LT | FDA UDI | Class II | Unknown |
| Titan™ | HSP-0923-070-001E | FDA UDI | Class I | Active |
| Cadence® | 10204278 | FDA UDI | Class I | Active |
| KGTI™ Kinetik Great Toe Implant System | 015004 | FDA UDI | Class I | Unknown |
| Ascension® | TRL10120P | FDA UDI | Class II | Active |
| Cadence™ | 10206209 | FDA UDI | Class I | Active |
| Salto Talaris® | YKAL06T | FDA UDI | Class I | Unknown |
| Cadence® | 10208113 | FDA UDI | Class II | Active |
| Integra® External Fixation System | 12224252 | FDA UDI | Class II | Active |
| CAPTURE™ High Torque Screw System | CSS50000034030T | FDA UDI | Class II | Active |
| Integra® Total Wrist Fusion System | 303412 | FDA UDI | Class I | Active |
| Titan™ | SP0920068001 | FDA UDI | Class I | Active |
| Cadence™ | 10209117 | FDA UDI | Class II | Active |
| Salto Talaris® | LJV525T | FDA UDI | Class II | Active |
| KGTI™ Kinetik Great Toe Implant System | 012012 | FDA UDI | U | Unknown |
| Cadence™ | 10205005 | FDA UDI | Class I | Active |
| Salto Talaris® | MJV501T | FDA UDI | Class I | Active |
| Construct® | gS 86-1002 | FDA UDI | Class I | Unknown |
| Capture™ | AI-3010 | FDA UDI | Class I | Active |
| CAPTURE™ High Torque Screw System | CSS50000043010T | FDA UDI | Class II | Active |
| Integra® Ti6® Internal Fixation System | DS2038 | FDA UDI | Class II | Active |
| Integra® Proximal Humeral Fracture Plate System | PSS2720LS | FDA UDI | Class II | Active |
| Titan™ Reverse Shoulder System | SCW096005545 | FDA UDI | Class II | Active |
| Cadence™ | 10203006 | 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.
| 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. |