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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 1 of 80| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Integra® MemoFix® | MS101513 | FDA UDI | Class II | Active |
| Universal 2™ Total Wrist Implant System | 268650 | FDA UDI | Class I | Active |
| Salto Talaris® | MJU350T | FDA UDI | Class I | Active |
| Titan™ Total Shoulder System | M9200104620C | FDA UDI | Class II | Active |
| KGTI™ Kinetik Great Toe Implant System | 015002 | FDA UDI | Class I | Unknown |
| Titan™ Reverse Shoulder System | LNR096000R | FDA UDI | Class II | Active |
| Panta® 2 | PAN-1010-10210 | FDA UDI | Class II | Active |
| Ascension® NuGrip® | NUG44320M | FDA UDI | Class II | Active |
| Cadence™ | 10204172 | FDA UDI | Class I | Active |
| Integra® | CGT-LIDT | FDA UDI | Class I | Active |
| Integra® | IMP30000 | FDA UDI | Class I | Active |
| Capture™ | TPS-5000-501-070 | FDA UDI | Class I | Active |
| Titan™ | HS0920069001 | FDA UDI | Class I | Active |
| Panta® 2 | PAN-1010-1424 | FDA UDI | Class II | Unknown |
| Titan™ | RGB096008STD | FDA UDI | Class I | Active |
| Salto Talaris® | YKAL54T | FDA UDI | Class I | Unknown |
| Integra® Titanium Bone Wedge System | TBW-1006-LG12 | FDA UDI | Class II | Unknown |
| Integra® XT | LJU282T | FDA UDI | Class II | Active |
| Integra® XT | LJU292T | FDA UDI | Class II | Active |
| Salto Talaris® | YRAL541T | FDA UDI | Class I | Unknown |
| Integra® Freedom Wrist Arthroplasty System | 348047 | FDA UDI | Class I | Active |
| Construct® Ankle Fusion Plate System | PSS4560LT | FDA UDI | Class II | Unknown |
| Integra® Proximal Humeral Fracture Plate System | PSS3535CS | FDA UDI | Class II | Active |
| CAPTURE™ High Torque Screw System | CSS50000017050T | FDA UDI | Class II | Active |
| Titan™ | RMR-0926-00N | FDA UDI | Class I | Active |
| Ascension® | CSA10006 | FDA UDI | Class I | Active |
| Integra® Total Foot System | 2830016 | FDA UDI | Class II | Active |
| Construct® Ankle Fusion Plate System | PSS4514CT | FDA UDI | Class II | Unknown |
| Panta® 2 | PAN-1010-0012 | FDA UDI | Class I | Active |
| Titan™ | SCW-0961-046-50 | FDA UDI | Class II | Active |
| Katalyst™ Bipolar Radial Head System | 224321 | FDA UDI | Class I | Active |
| Titan™ | CSA-0923-05 | FDA UDI | Class I | Active |
| Integra® Total Foot System | 2802100 | FDA UDI | Class II | Active |
| Integra®Ti6® | TC3012 | FDA UDI | Class II | Active |
| Cadence™ | 10207214 | FDA UDI | Class II | Active |
| Integra® | RTKTFS01 | FDA UDI | Class I | Active |
| Titan™ | GPG-0940-042-002 | FDA UDI | Class I | Unknown |
| Universal 2™ Total Wrist System | 264530S | FDA UDI | Class II | Active |
| Titan™ | T92012010SML | FDA UDI | Class I | Active |
| Integra® TruArch® | TA3012 | FDA UDI | Class I | Unknown |
| Cadence™ | 10209508 | FDA UDI | Class II | Active |
| Titan™ | CSA-0923-02 | FDA UDI | Class I | Active |
| Cadence™ | 10204117 | FDA UDI | Class I | Unknown |
| Titan™ | DG0920049002 | FDA UDI | Class I | Active |
| Cadence™ | 10206510 | FDA UDI | Class I | Active |
| Integra® Ti6® Internal Fixation System | DS2046 | FDA UDI | Class II | Active |
| NuGrip® CMC Implant System | CUT443M | FDA UDI | Class I | Active |
| Ti6® Internal Fixation System | DS3010 | FDA UDI | Class I | Active |
| EndoRelease™ Cubital Tunnel System | 096000 | FDA UDI | Class I | Active |
| Integra® PyroSphere® | TRL43520 | FDA UDI | Class II | 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. |