Chrysalis Intelligence · Sponsors · Orthofix, Inc.

Orthofix, Inc.

Lewisville, TX, US · 14 510(k) clearances · 3 PMAs

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Total clearances
14
2020-04-02 → 2024-05-28
Last 12 months
0
Product codes
5
Most recent
2024-05-28
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
ODP Intervertebral Fusion Device With Bone Graft, Cervical Class II Orthopedic 5 2021-08-31
OUR Sacroiliac Joint Fixation Class II Orthopedic 4 2021-03-25
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Class II Orthopedic 2 2024-05-28
NKG Posterior Cervical Screw System Class II Orthopedic 2 2021-07-30
FMF — — — 1 2020-05-01
Class III

PMA approvals (3)

Total PMA records
3
Originals + supplements
Distinct product codes
1
First decision
2020-03-27
Most recent
2022-06-14
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2022-06-14 P850007-S046 PhysioStim®, SpinalStim® Real-Time Process LOF Stimulator, Bone Growth, Non-Invasive Orthopedic
2022-06-14 P030034-S017 CervicalStim® Real-Time Process LOF Stimulator, Bone Growth, Non-Invasive Orthopedic
2020-03-27 P850007-S044 SpinalStim 30-Day Notice LOF Stimulator, Bone Growth, Non-Invasive Orthopedic
Filings

All 510(k) clearances (14)

Date K-number Device Code Class Specialty
2024-05-28 K240749 PILLAR SA Ti Spacer System (82-XXX) MAX Class II Orthopedic
2021-08-31 K211704 CONSTRUX Mini PEEK Spacer System/CONSTRUX Mini PEEK VBR System, CONSTRUX Mini PTC Spacer System, CONSTRUX Mini Ti Spacer System, FORZA PEEK Spacer System, FORZA PTC Spacer System, FORZA Ti Spacer System, FORZA XP Expandable Spacer System, Lonestar Cervical Standalone System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, PILLAR SA PTC Spacer System, SKYHAWK Lateral Interbody Fusion System ODP Class II Orthopedic
2021-07-30 K211710 Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal Fixation Systems: (Firebird Deformity Spinal Fixation System, Phoenix MIS Spinal Fixation System, Phoenix CDX MIS Spinal Fixation System, JANUS Midline Fixation Screws, Firebird NXG Spinal Fixation System, JANUS Fenestrated Screws), Connector System, FIREBIRD SI Fusion System NKG Class II Orthopedic
2021-03-25 K210667 FIREBIRD SI Fusion System OUR Class II Orthopedic
2021-03-18 K203342 CONSTRUX Mini Ti Spacer System ODP Class II Orthopedic
2021-03-03 K203576 FORZA Ti Spacer System MAX Class II Orthopedic
2020-11-18 K203138 FIREBIRD SI Fusion System OUR Class II Orthopedic
2020-10-29 K202949 CONSTRUX Mini PEEK Spacer System ODP Class II Orthopedic
2020-10-14 K202666 CONSTRUX Mini PTC Spacer System ODP Class II Orthopedic
2020-09-15 K201664 FIREBIRD SI Fusion System OUR Class II Orthopedic
2020-06-15 K201481 Centurion POCT System NKG Class II Orthopedic
2020-05-01 K200606 O-Genesis Graft Delivery System FMF — —
2020-04-09 K200052 CONSTRUX Mini PTC Spacer System, FORZA PTC Spacer System, PILLAR SA PTC Spacer System ODP Class II Orthopedic
2020-04-02 K200696 FIREBIRD SI Fusion System OUR Class II Orthopedic
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence