# Orthofix, Inc.

- Location (FDA's records): Lewisville, TX
- FDA decisions: 100 (1986–2026): 98 510(k) clearances and 2 original PMA approvals
- Names in FDA's records: Orthofix, Inc. (59); Orthofix Srl (38); Orthofix (3)
- Product codes: HSB (14), KTT (11), ODP (10), NKB (9), HRS (7), MAX (7), NKG (7), KWQ (5), OUR (5), OBT (4), LOF (2), OLO (2)
- 510(k) review time since 2016: median 86 days, against 107 for FDA's reviews in the same codes and years (30 of 53 faster)
- Predicates its devices cite: 218 (84 its own); citations of its devices by later devices: 203 (84 its own)
- Recalls linked to its devices: 57 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Blackstone Medical, Inc.: 30 (https://510kreport.com/company/blackstone-medical)
- Synthes (Usa): 10 (https://510kreport.com/company/synthes-usa)
- Medtronic Sofamor Danek USA, Inc.: 5 (https://510kreport.com/company/medtronic-sofamor-danek-usa)
- OrthoPediatrics Corp.: 4 (https://510kreport.com/company/orthopediatrics)
- Nuvasive, Inc.: 3 (https://510kreport.com/company/nuvasive)
- Smith & Nephew, Inc.: 3 (https://510kreport.com/company/smith-nephew)
- Stryker Corp.: 3 (https://510kreport.com/company/stryker)
- Additive Implants, Inc.: 3 (https://510kreport.com/company/additive-implants)

## Firms that cite its devices most
- Life Spine, Inc.: 6 (https://510kreport.com/company/life-spine)
- Zavation Medical Products, LLC: 5 (https://510kreport.com/company/zavation-medical-products)
- Wishbone Medical, Inc.: 5 (https://510kreport.com/company/wishbone-medical)
- Vilex, LLC: 4 (https://510kreport.com/company/vilex)
- Orthofix US, LLC: 3 (https://510kreport.com/company/orthofix-us)
- Spinecraft, LLC: 3 (https://510kreport.com/company/spinecraft)
- SeaSpine Orthopedics Corporation: 3 (https://510kreport.com/company/seaspine-orthopedics)
- Corelink, LLC: 3 (https://510kreport.com/company/corelink)

## Its most-cited devices
- K955848: Orthofix Modulsystem (1996), cited by 14
- K180179: Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird® NXG Spinal Fixation System; Phoenix® Minimally Invasive Spinal Fixation System; Phoenix® CDX™ Minimally Invasive Spinal Fixation System; JANUS® Midline Fixation Screw; JANUS® Fenestrated Screw (2018), cited by 12
- K152475: FORZA PTC Spacer System (2016), cited by 10
- K142152: Construx Mini Peek; Spacer System, TI Spacer System, Cervical Stand Alone System (2015), cited by 6
- K122901: Firebird Spinal Fixation System, Phoenix Mis Spinal Fixation System (2012), cited by 6
- K171082: Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline Fixation Screw, Phoenix CDX MIS Spinal Fixation System, Firebird NXG Spinal Fixation System (2017), cited by 6

## Recent decisions
- K260146: Fitbone® Transport and Lengthening System (May 19, 2026)
- K253991: Fitbone™ Trochanteric,  FITBONE® Transport and Lengthening System,  FITBONE® TAA (May 8, 2026)
- K250112: FitboneTM Trochanteric (Apr 10, 2025)
- K242270: OrthoNext Platform System (Dec 19, 2024)
- K242861: TrueLok Elevate (Dec 3, 2024)
- K233867: Fitbone Trochanteric (Jun 18, 2024)
- K240749: PILLAR SA Ti Spacer System (82-XXX) (May 28, 2024)
- K232648: RODEO Telescopic Nail (May 3, 2024)

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