# Arrowhead De, LLC

- Location (FDA's records): Collierville, TN
- FDA decisions: 3 (2017–2020): 3 510(k) clearances
- Product codes: KTT (3)
- 510(k) review time since 2016: median 214 days, against 184 for FDA's reviews in the same codes and years (0 of 3 faster)
- Predicates its devices cite: 13 (1 its own); citations of its devices by later devices: 4 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Stryker Corp.: 3 (https://510kreport.com/company/stryker)
- Smith & Nephew, Inc.: 1 (https://510kreport.com/company/smith-nephew)
- Smith & Nephew, Inc., Orthopaedic Div.: 1 (https://510kreport.com/company/smith-nephew-orthopaedic-div)
- Arrowhead Medical Device Technologies, LLC: 1 (https://510kreport.com/company/arrowhead-medical-device-technologies)
- Richards Medical Co., Inc.: 1 (https://510kreport.com/company/richards-medical)
- Smith & Nephew Richards, Inc.: 1 (https://510kreport.com/company/smith-nephew-richards)
- Wrightmedicaltechnologyinc: 1 (https://510kreport.com/company/wrightmedicaltechnologyinc)
- Apex Tools & Orthopedics Co.: 1 (https://510kreport.com/company/apex-tools-orthopedics)

## Firms that cite its devices most
- Paragon 28, Inc.: 1 (https://510kreport.com/company/paragon-28)
- Amdt Holdings, Inc.: 1 (https://510kreport.com/company/amdt-holdings)
- Disior, Ltd.: 1 (https://510kreport.com/company/disior)

## Its most-cited devices
- K190069: SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) (2019), cited by 3
- K162032: Arrowhead Mini-Rail Fixator (2017), cited by 1

## Recent decisions
- K200123: Accessories for the SixFix® Hexapod Fixator (Sep 22, 2020)
- K190069: SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) (May 14, 2019)
- K162032: Arrowhead Mini-Rail Fixator (Feb 21, 2017)

Source page: https://510kreport.com/company/arrowhead