# Orthofix US, LLC

- Location (FDA's records): Lewisville, TX
- FDA decisions: 5 (2022–2025): 4 510(k) clearances and 1 original PMA approval
- Product codes: LLZ (1), MAX (1), KWQ (1), OLO (1), LOF (1)
- 510(k) review time since 2016: median 180 days, against 107 for FDA's reviews in the same codes and years (1 of 4 faster)
- Predicates its devices cite: 11 (0 its own); citations of its devices by later devices: 3 (0 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
- Blackstone Medical, Inc.: 5 (https://510kreport.com/company/blackstone-medical)
- Orthofix, Inc.: 3 (https://510kreport.com/company/orthofix)
- Nemaris, Inc.: 1 (https://510kreport.com/company/nemaris)
- SeaSpine Orthopedics Corporation: 1 (https://510kreport.com/company/seaspine-orthopedics)
- Medtronic Navigation, Inc.: 1 (https://510kreport.com/company/medtronic-navigation)

## Firms that cite its devices most
- Orthofix Medical, Inc.: 1 (https://510kreport.com/company/orthofix-medical)
- Elliquence, LLC: 1 (https://510kreport.com/company/elliquence)
- Life Spine, Inc.: 1 (https://510kreport.com/company/life-spine)

## Its most-cited devices
- K213951: FORZA XP Expandable Spacer System (2022), cited by 2
- K252088: Firebird SI Navigation System (2025), cited by 1

## Recent decisions
- K252088: Firebird SI Navigation System (Oct 31, 2025)
- K230252: OFIX MIS App (Sep 26, 2023)
- P210035: AccelStimTM Bone Growth Stimulator (May 3, 2022)
- K211712: 3° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity Lumbosacral Fixation System, Hallmark Anterior Plate System, NewBridge Laminoplasty Fixation System, CETRA Anterior Cervical Plate System (Feb 11, 2022)
- K213951: FORZA XP Expandable Spacer System (Jan 5, 2022)

Source page: https://510kreport.com/company/orthofix-us