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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device sacroiliac joint fixation
Regulation Description Smooth or threaded metallic bone fixation fastener.
Definition sacroiliac joint fusion
Product CodeOUR
Regulation Number 888.3040
Device Class 2


Premarket Reviews
ManufacturerDecision
4WEB MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ADVANCED RESEARCH MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
AEGIS SPINE
  SUBSTANTIALLY EQUIVALENT 1
AEGIS SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 2
ALEVIO, LLC
  SUBSTANTIALLY EQUIVALENT 2
ANJALI INVESTMENTS L.L.C
  SUBSTANTIALLY EQUIVALENT 1
ASTURA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
AURORA SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
CAMBER SPINE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
CAMBER SPINE TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
CHOICE SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
CORELINK, LLC
  SUBSTANTIALLY EQUIVALENT 1
CTL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CURITEVA, INC.
  SUBSTANTIALLY EQUIVALENT 1
CUTTING EDGE SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 2
DELTACOR GMBH
  SUBSTANTIALLY EQUIVALENT 1
DIO MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
EMINENT SPINE
  SUBSTANTIALLY EQUIVALENT 1
EMINENT SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
FOUNDATION FUSION SOLUTIONS, LLC (DBA CORNERLOC)
  SUBSTANTIALLY EQUIVALENT 2
GENESYS SPINE
  SUBSTANTIALLY EQUIVALENT 1
HT MEDICAL D.B.A. XENIX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
HT MEDICAL, LLC DBA XENIX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
L&K BIOMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
LESSPINE INNOVATIONS
  SUBSTANTIALLY EQUIVALENT 1
LIFE SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 2
MCNICOLL SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC SOFAMOR DANEK USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEXXT SPINE
  SUBSTANTIALLY EQUIVALENT 1
OMNIA MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFUNDAMENTALS, LLC
  SUBSTANTIALLY EQUIVALENT 1
OSSEUS FUSION SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
OSTEOCENTRIC TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 2
PROMETHEAN RESTORATIVE, LLC
  SUBSTANTIALLY EQUIVALENT 2
SAIL FUSION, LLC
  SUBSTANTIALLY EQUIVALENT 1
SI SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
SI-BONE, INC.
  SUBSTANTIALLY EQUIVALENT 11
SI-TECHNOLOGY, LLC
  SUBSTANTIALLY EQUIVALENT 2
SIVANTAGE
  SUBSTANTIALLY EQUIVALENT 1
SPINAL SIMPLICITY, LLC
  SUBSTANTIALLY EQUIVALENT 3
SPINUS INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SURGENTEC
  SUBSTANTIALLY EQUIVALENT 1
SURGENTEC, LLC
  SUBSTANTIALLY EQUIVALENT 6
TENON MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
TENON MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
VGI MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
WENZEL SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 154 156
2022 23 23
2023 7 7
2024 15 15
2025 10 10
2026 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Malposition of Device 110 110
Adverse Event Without Identified Device or Use Problem 54 54
Loss of Osseointegration 29 29
Inadequacy of Device Shape and/or Size 16 16
Appropriate Device Problem Term/Code Not Available 4 4
Fracture 3 3
Improper or Incorrect Procedure or Method 3 3
Material Fragmentation 2 2
Insufficient Device Problem Information 2 2
No Apparent Adverse Event 2 2
Migration 2 2
Expiration Date Error 1 1
Material Integrity Problem 1 1
Patient Device Interaction Problem 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Difficult to Insert 1 1
Use of Device Problem 1 1
Component Missing 1 1
Failure to Osseointegrate 1 1
Solder Joint Fracture 1 1
Detachment of Device or Device Component 1 1
Osseointegration Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Arthralgia 83 85
Undesired Nerve Stimulation 72 72
No Clinical Signs, Symptoms or Conditions 10 10
Bone Fracture(s) 9 9
Hemorrhage/Blood Loss/Bleeding 7 7
Pain 7 7
Implant Pain 6 6
Cellulitis 6 6
Hematoma 5 5
Pseudoaneurysm 4 4
Nerve Damage 3 3
Insufficient Information 3 3
Hypersensitivity/Allergic reaction 2 2
Failure of Implant 2 4
Inadequate Osseointegration 2 2
Post Operative Wound Infection 2 2
Wound Infection 2 2
Foreign Body In Patient 2 2
Discomfort 2 2
Joint Laxity 2 2
Swelling/ Edema 2 2
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 2 2
Unspecified Infection 1 1
Vascular Dissection 1 1
Back pain 1 1
Extraskeletal ossification 1 1
Thrombosis/Thrombus 1 1
Osteomyelitis 1 1
Loss of Range of Motion 1 1
Numbness 1 1
Ambulation or Postural Difficulties 1 1
Nonunion/Delayed-union Bone Fracture 1 1
Limb Pain 1 1
Perforation of Vessels 1 1
Bacterial Infection 1 1
Deformity/ Disfigurement 1 1
Inadequate Pain Relief 1 3
Low Blood Pressure/ Hypotension 1 1
Joint Impingement 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Orthofix U.S. LLC III Dec-11-2025
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