# Ascension Orthopedic

- Location (FDA's records): Austin, TX
- FDA decisions: 7 (2011–2014): 7 510(k) clearances
- Product codes: KWS (2), HRS (1), KTT (1), KYI (1), HWC (1), KXE (1)
- Predicates its devices cite: 14 (0 its own); citations of its devices by later devices: 7 (0 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ascension Orthopedics, Inc.: 4 (https://510kreport.com/company/ascension-orthopedics)
- Lima Corporate S.P.A.: 2 (https://510kreport.com/company/lima-corporate)
- Wrightmedicaltechnologyinc: 1 (https://510kreport.com/company/wrightmedicaltechnologyinc)
- Ebi, L.P.: 1 (https://510kreport.com/company/ebi)
- Instratek, Inc.: 1 (https://510kreport.com/company/instratek)
- Smith & Nephew, Inc.: 1 (https://510kreport.com/company/smith-nephew)
- Depuy France S.A.S.: 1 (https://510kreport.com/company/depuy-france)
- DePuy Orthopaedics, Inc.: 1 (https://510kreport.com/company/depuy-orthopaedics)

## Firms that cite its devices most
- Ascension Orthopedics, Inc.: 2 (https://510kreport.com/company/ascension-orthopedics)
- Additive Orthopaedics, LLC: 1 (https://510kreport.com/company/additive-orthopaedics)
- New Standard Device Dba Metalogix: 1 (https://510kreport.com/company/new-standard-device-dba-metalogix)
- Integra LifeSciences Corporation: 1 (https://510kreport.com/company/integra-lifesciences)
- Additive Device, Inc. (Adi) D/B/A Restor3D: 1 (https://510kreport.com/company/additive-device-adi-d-b-a-restor3d)
- Smith & Nephew, Inc.: 1 (https://510kreport.com/company/smith-nephew)

## Its most-cited devices
- K131360: Integra Titanium Bone Wedge (2013), cited by 2
- K112438: Titan Modular Total Shoulder System (2012), cited by 2
- K140463: Integra External Fixation System (2014), cited by 2
- K130050: Titan Reverse Shoulder System (2013), cited by 1

## Recent decisions
- K140463: Integra External Fixation System (Oct 10, 2014)
- K131360: Integra Titanium Bone Wedge (Aug 7, 2013)
- K130050: Titan Reverse Shoulder System (Jun 18, 2013)
- K112438: Titan Modular Total Shoulder System (Apr 11, 2012)
- K112481: First Choice Druj System, Partial Head Implant (Apr 9, 2012)
- K112278: Ascension Nugrip CMC Implant (Nov 4, 2011)
- K111799: Nugait (TM) Subtalar Implant System (Aug 19, 2011)

Source page: https://510kreport.com/company/ascension-orthopedic