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Sign in to claim this brandAscension Orthopedics, Inc.
US
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
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- Phone
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- 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 70 of 80| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Titan™ | GU0920058001 | FDA UDI | Class I | Active |
| Integra® Total Foot System | 2822010 | FDA UDI | Class II | Active |
| Titan™ | CVR0920077S | FDA UDI | Class I | Active |
| Integra® | G207153 | FDA UDI | Class I | Active |
| CAPTURE™ High Torque Screw System | CSS50000052522T | FDA UDI | Class II | Active |
| Integra® Ti6® Internal Fixation System | TS4050 | FDA UDI | Class II | Active |
| CAPTURE™ High Torque Screw System | CSS50000034026T | FDA UDI | Class II | Active |
| Titan™ | T9200104821E | FDA UDI | Class I | Active |
| Integra® | CSA85001 | FDA UDI | Class I | Active |
| Integra® | 5010001 | FDA UDI | Class I | Active |
| Integra® Total Foot System | 2801224 | FDA UDI | Class II | Active |
| Integra® Total Wrist Fusion System | 303214 | FDA UDI | Class II | Active |
| Titan™ | HSP0920070003 | FDA UDI | Class I | Active |
| CAPTURE™ High Torque Screw System | CSS50000017090PT | FDA UDI | Class II | Active |
| Universal 2™ Total Wrist Implant System | 268114 | FDA UDI | Class I | Active |
| Construct® Ankle Fusion Plate System | PSS6565LT | FDA UDI | Class II | Unknown |
| Titan™ | LNR-0960-191-6S | FDA UDI | Class II | Active |
| Ascension PIP | PIP-200-40P-WW | FDA UDI | Unclassified | Active |
| Universal 2™ Total Wrist Implant System | 268340 | FDA UDI | Class I | Active |
| Titan™ Total Shoulder System | SEM095002508 | FDA UDI | Class II | Active |
| Integra® Freedom Wrist Arthroplasty System | 348044 | FDA UDI | Class I | Active |
| Capture™ | TRC-5000-507-070 | FDA UDI | Class I | Active |
| Cadence™ | 10209320 | FDA UDI | Class II | Active |
| Titan™ Total Shoulder System | GLN092003003P | FDA UDI | Class II | Active |
| Integra® | SZT71504S | FDA UDI | Class I | Active |
| Titan™ | RMR096004701 | FDA UDI | Class I | Active |
| Cadence™ | 10209552 | FDA UDI | Class II | Active |
| Ascension® | SILMCPINSTP | FDA UDI | Class II | Unknown |
| Salto Talaris® | LJU221T | FDA UDI | Class II | Active |
| CAPTURE™ High Torque Screw System | CSS500000170115PT | FDA UDI | Class II | Active |
| Salto Talaris® | LJU269T | FDA UDI | Class II | Active |
| Cadence™ | 10209340 | FDA UDI | Class II | Active |
| Integra® Spider™ Limted Wrist Fusion System | 062810 | FDA UDI | Class II | Active |
| Integra® | SZR9004418 | FDA UDI | Class I | Active |
| Salto Talaris® | MJV502T | FDA UDI | Class I | Active |
| Integra® | CSA20002 | FDA UDI | Class I | Active |
| Integra® MemoFix® | STAPLEIMP | FDA UDI | Class II | Unknown |
| Integra® Total Wrist Fusion System | 303328 | FDA UDI | Class II | Active |
| Construct® Ankle Fusion Plate System | AFPIMP | FDA UDI | Class II | Unknown |
| Cadence™ | CSA-1020-0013 | FDA UDI | Class I | Unknown |
| Integra® External Fixation System | XFIX3INSTP | FDA UDI | Class I | Unknown |
| Capture™ | AW1111 | FDA UDI | Class I | Active |
| Cadence® | 10204286 | FDA UDI | Class I | Active |
| Capture™ | CND-5000-510-040 | FDA UDI | Class I | Active |
| Titan™ | T9200105220C | FDA UDI | Class I | Active |
| Integra®Ti6® | TC4040 | FDA UDI | Class II | Active |
| Salto Talaris® | MJU373T | FDA UDI | Class I | Active |
| Integra® XT | MJV111T | FDA UDI | Class I | Unknown |
| Titan™ | T95012008SML | FDA UDI | Class II | Active |
| Integra® Proximal Humeral Fracture Plate System | PSS3565PS | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
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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. |