Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device sacroiliac joint fixation
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 2
CAMBER SPINE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 2
CAMBER SPINE TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
CHOICESPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
COORSTEK MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
CORELINK, LLC
  SUBSTANTIALLY EQUIVALENT 2
CTL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CURITEVA, INC.
  SUBSTANTIALLY EQUIVALENT 1
CUTTING EDGE SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 3
DELTACOR GMBH
  SUBSTANTIALLY EQUIVALENT 1
DIO MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
FOLSOM METAL PRODUCTS, INC. DBA FRONTIER DEVICES
  SUBSTANTIALLY EQUIVALENT 1
FOUNDATION FUSION SOLUTIONS, LLC (DBA CORNERLOC)
  SUBSTANTIALLY EQUIVALENT 2
GENESYS SPINE
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
HT MEDICAL D.B.A. XENIX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
HT MEDICAL LLC DBA XENIX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
HUVEXEL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
ILION MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
L & K BIOMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
L&K BIOMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
LESSPINE INNOVATIONS
  SUBSTANTIALLY EQUIVALENT 1
LIFE SPINE INC.
  SUBSTANTIALLY EQUIVALENT 2
LIFE SPINE, INC
  SUBSTANTIALLY EQUIVALENT 1
LIFE SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 3
MEDTRONIC SOFAMOR DANEK
  SUBSTANTIALLY EQUIVALENT 2
ORTHOFIX INC.
  SUBSTANTIALLY EQUIVALENT 5
ORTHOFUNDAMENTALS, LLC
  SUBSTANTIALLY EQUIVALENT 1
OSSEUS FUSION SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
OSTEOCENTRIC TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 2
SAIL FUSION, LLC
  SUBSTANTIALLY EQUIVALENT 1
SI-BONE, INC
  SUBSTANTIALLY EQUIVALENT 1
SI-BONE, INC.
  SUBSTANTIALLY EQUIVALENT 21
SI-TECHNOLOGY, LLC
  SUBSTANTIALLY EQUIVALENT 1
SICAGE LLC
  SUBSTANTIALLY EQUIVALENT 1
SIJ SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
SPINAL SIMPLICITY LLC
  SUBSTANTIALLY EQUIVALENT 2
SPINEFRONTIER, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINUS INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SURGENTEC
  SUBSTANTIALLY EQUIVALENT 1
SURGENTEC, LLC
  SUBSTANTIALLY EQUIVALENT 3
TENON MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
VGI MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
X-SPINE SYSTEMS, INC
  SUBSTANTIALLY EQUIVALENT 1
X-SPINE SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZAVATION MEDICAL PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ZYGA TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 6

MDR Year MDR Reports MDR Events
2014 146 146
2015 119 119
2016 122 122
2017 157 157
2018 137 137
2019 175 175
2020 148 148
2021 154 154
2022 23 23
2023 7 7
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Malposition of Device 611 611
Adverse Event Without Identified Device or Use Problem 296 296
Loss of Osseointegration 99 99
Inadequacy of Device Shape and/or Size 66 66
Insufficient Information 56 56
Failure to Osseointegrate 25 25
Positioning Problem 21 21
Appropriate Term/Code Not Available 16 16
Device Operates Differently Than Expected 15 15
Difficult to Remove 14 14
Break 12 12
Improper or Incorrect Procedure or Method 9 9
Migration or Expulsion of Device 8 8
Device Handling Problem 7 7
Device Dislodged or Dislocated 6 6
Patient-Device Incompatibility 5 5
Loose or Intermittent Connection 5 5
Device Slipped 5 5
Use of Device Problem 4 4
Entrapment of Device 4 4
Fracture 4 4
Device Damaged by Another Device 4 4
Loosening of Implant Not Related to Bone-Ingrowth 3 3
Migration 3 3
Patient Device Interaction Problem 2 2
Difficult to Advance 2 2
Material Fragmentation 2 2
Contamination 2 2
Detachment of Device or Device Component 2 2
Fitting Problem 2 2
Component Missing 1 1
Solder Joint Fracture 1 1
Cut In Material 1 1
Structural Problem 1 1
Failure to Advance 1 1
Device Markings/Labelling Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
Human-Device Interface Problem 1 1
Material Integrity Problem 1 1
Material Protrusion/Extrusion 1 1
Failure To Adhere Or Bond 1 1
Bent 1 1
Difficult to Insert 1 1
Unexpected Therapeutic Results 1 1
Unstable 1 1
Packaging Problem 1 1
Protective Measures Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Unintended Movement 1 1
No Apparent Adverse Event 1 1
Incomplete or Inadequate Connection 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Arthralgia 437 437
Undesired Nerve Stimulation 417 417
Pain 319 319
Joint Disorder 82 82
Nerve Proximity Nos (Not Otherwise Specified) 72 72
No Code Available 27 27
Bone Fracture(s) 26 26
Hematoma 16 16
Hemorrhage/Bleeding 15 15
No Known Impact Or Consequence To Patient 15 15
Physical Entrapment 15 15
Fall 13 13
Bacterial Infection 11 11
Unspecified Infection 10 10
Inadequate Pain Relief 9 9
Numbness 9 9
No Information 8 8
Cellulitis 8 8
Hypersensitivity/Allergic reaction 6 6
Patient Problem/Medical Problem 6 6
Failure of Implant 5 5
Pulmonary Embolism 4 4
Device Embedded In Tissue or Plaque 4 4
No Clinical Signs, Symptoms or Conditions 4 4
Insufficient Information 3 3
Implant Pain 3 3
Pseudoaneurysm 3 3
Therapeutic Response, Decreased 3 3
Osteopenia/ Osteoporosis 3 3
Disc Impingement 3 3
Foreign Body In Patient 3 3
Ambulation Difficulties 3 3
Burning Sensation 3 3
Tingling 3 3
Cardiac Arrest 3 3
Dyspnea 3 3
Irritation 3 3
Perforation of Vessels 3 3
Thrombosis 2 2
Respiratory Distress 2 2
Chest Pain 2 2
Death 2 2
No Consequences Or Impact To Patient 2 2
Discomfort 2 2
Complaint, Ill-Defined 2 2
Post Operative Wound Infection 2 2
Blood Loss 2 2
Test Result 2 2
Joint Laxity 2 2
Malunion of Bone 1 1
Missing Value Reason 1 1
Thrombosis/Thrombus 1 1
Swelling/ Edema 1 1
Vascular Dissection 1 1
Needle Stick/Puncture 1 1
Irregular Pulse 1 1
Cognitive Changes 1 1
Toxicity 1 1
Injury 1 1
Discharge 1 1
Neck Pain 1 1
Reaction 1 1
Osteolysis 1 1
Impaired Healing 1 1
Non-union Bone Fracture 1 1
Disability 1 1
Ossification 1 1
Abscess 1 1
Atrial Fibrillation 1 1
Bruise/Contusion 1 1
Fever 1 1
Low Blood Pressure/ Hypotension 1 1
Septic Shock 1 1
Skin Discoloration 1 1
Swelling 1 1
Thrombus 1 1
Tissue Damage 1 1
Weakness 1 1
Nerve Damage 1 1
Inflammation 1 1
Pneumonia 1 1
Rash 1 1
Occlusion 1 1

-
-