# Ascension Orthopedics, Inc.

- Location (FDA's records): Austin, TX
- FDA decisions: 29 (2002–2024): 29 510(k) clearances
- Names in FDA's records: Ascension Orthopedics, Inc. (22); Ascension Orthopedics (7)
- Product codes: HRS (4), KYI (3), KYJ (3), KWS (3), HWC (3), HSD (2), HSN (2), KWD (2), LZJ (1), KXE (1), KWI (1), KWN (1)
- 510(k) review time since 2016: median 150 days, against 135 for FDA's reviews in the same codes and years (2 of 4 faster)
- Predicates its devices cite: 59 (10 its own); citations of its devices by later devices: 44 (10 its own)
- Recalls linked to its devices: 19 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Wrightmedicaltechnologyinc: 6 (https://510kreport.com/company/wrightmedicaltechnologyinc)
- Synthes (Usa): 4 (https://510kreport.com/company/synthes-usa)
- DePuy Orthopaedics, Inc.: 3 (https://510kreport.com/company/depuy-orthopaedics)
- Depuy, Inc.: 3 (https://510kreport.com/company/depuy)
- Kinetikos Medical, Inc.: 2 (https://510kreport.com/company/kinetikos-medical)
- Biomet Manufacturing Corp: 2 (https://510kreport.com/company/biomet-manufacturing)
- Biomet, Inc.: 2 (https://510kreport.com/company/biomet)
- Dow Corning Wright: 2 (https://510kreport.com/company/dow-corning-wright)

## Firms that cite its devices most
- Smith & Nephew, Inc.: 6 (https://510kreport.com/company/smith-nephew)
- Ascension Orthopedic: 4 (https://510kreport.com/company/ascension-orthopedic)
- Integra LifeSciences Corporation: 4 (https://510kreport.com/company/integra-lifesciences)
- Wrightmedicaltechnologyinc: 2 (https://510kreport.com/company/wrightmedicaltechnologyinc)
- Ensemble Orthopedics, LLC: 2 (https://510kreport.com/company/ensemble-orthopedics)
- Brm Extremities: 2 (https://510kreport.com/company/brm-extremities)
- Extremity Medical, LLC: 2 (https://510kreport.com/company/extremity-medical)
- Biopro, Inc.: 1 (https://510kreport.com/company/biopro)

## Its most-cited devices
- K151459: Integra Total Ankle Replacement System (2015), cited by 4
- K061451: Ascension, Models CMC-400,13,CMC-400-20,CMC-400-30,CMC-400-40 (2006), cited by 4
- K041451: Ascension Pyrohemisphere, Models PHS-440-10, PHS-440-20, PHS-440-30, PHS-440-40, PHS-440-50 (2004), cited by 3
- K042690: Ascension Pyrosphere (PCS) (2004), cited by 3
- K032686: Ascension Modular Radial Head (2003), cited by 3
- K022892: Ascension Sillicone MCP (2002), cited by 3

## Recent decisions
- K233674: Freedom Wrist Arthroplasty System (May 30, 2024)
- K233670: Ascension Silicone MCP; Ascension Silicone PIP (Dec 14, 2023)
- K182878: Integra Salto Total Ankle System (Dec 18, 2018)
- K162153: Integra® CAPTURE™ Screw System & Integra® Ti6® Internal Fixation System (Jul 14, 2017)
- K160830: Integra External Fixation System (Jul 6, 2016)
- K152047: INTEGRA TITAN Modular Total Shoulder System Fin-Lock Glenoid (Dec 23, 2015)
- K152527: Integra DigiFuse Cannulated Intramedullary Fusion System (Oct 29, 2015)
- K151459: Integra Total Ankle Replacement System (Aug 31, 2015)

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