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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
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
BIOFUSION MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
CAMBER SPINE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
CAMBER SPINE TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
CHOICESPINE, 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, LLC
  SUBSTANTIALLY EQUIVALENT 1
FOUNDATION FUSION SOLUTIONS, LLC (DBA CORNERLOC)
  SUBSTANTIALLY EQUIVALENT 2
HT MEDICAL D.B.A. XENIX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
HT MEDICAL LLC DBA XENIX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ILION MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
L & K BIOMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
L&K BIOMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
LESSPINE INNOVATIONS
  SUBSTANTIALLY EQUIVALENT 1
LIFE SPINE INC.
  SUBSTANTIALLY EQUIVALENT 1
LIFE SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1
NEXXT SPINE
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX INC.
  SUBSTANTIALLY EQUIVALENT 4
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-BONE INC.
  SUBSTANTIALLY EQUIVALENT 2
SI-BONE, INC
  SUBSTANTIALLY EQUIVALENT 1
SI-BONE, INC.
  SUBSTANTIALLY EQUIVALENT 7
SI-TECHNOLOGY, LLC
  SUBSTANTIALLY EQUIVALENT 1
SPINAL SIMPLICITY LLC
  SUBSTANTIALLY EQUIVALENT 2
SPINUS INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SURGENTEC
  SUBSTANTIALLY EQUIVALENT 1
SURGENTEC LLC
  SUBSTANTIALLY EQUIVALENT 2
SURGENTEC, LLC
  SUBSTANTIALLY EQUIVALENT 4
TENON MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
TENON MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
VGI MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 148 148
2021 154 154
2022 23 23
2023 7 7
2024 16 16
2025 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Malposition of Device 217 217
Adverse Event Without Identified Device or Use Problem 69 69
Loss of Osseointegration 53 53
Inadequacy of Device Shape and/or Size 34 34
Appropriate Term/Code Not Available 7 7
Break 3 3
Insufficient Information 3 3
Material Fragmentation 3 3
Migration 3 3
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Improper or Incorrect Procedure or Method 2 2
Incomplete or Inadequate Connection 1 1
Device Markings/Labelling Problem 1 1
Patient-Device Incompatibility 1 1
Therapeutic or Diagnostic Output Failure 1 1
Difficult to Remove 1 1
Patient Device Interaction Problem 1 1
Use of Device Problem 1 1
Component Missing 1 1
Structural Problem 1 1
Solder Joint Fracture 1 1
Packaging Problem 1 1
No Apparent Adverse Event 1 1
Fracture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Undesired Nerve Stimulation 155 155
Arthralgia 132 132
Bone Fracture(s) 13 13
Pain 8 8
Hemorrhage/Bleeding 8 8
Cellulitis 7 7
No Clinical Signs, Symptoms or Conditions 6 6
Hematoma 6 6
No Known Impact Or Consequence To Patient 5 5
Insufficient Information 4 4
Implant Pain 3 3
Pseudoaneurysm 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Hypersensitivity/Allergic reaction 2 2
Failure of Implant 2 2
Post Operative Wound Infection 2 2
Post Traumatic Wound Infection 2 2
Joint Laxity 2 2
Bacterial Infection 2 2
Inadequate Pain Relief 2 2
Unspecified Infection 1 1
Death 1 1
Vascular Dissection 1 1
Blood Loss 1 1
Ossification 1 1
Foreign Body In Patient 1 1
Thrombosis/Thrombus 1 1
Osteomyelitis 1 1
Discomfort 1 1
Malunion of Bone 1 1
Non-union Bone Fracture 1 1
Swelling/ Edema 1 1
Low Blood Pressure/ Hypotension 1 1
Device Embedded In Tissue or Plaque 1 1

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