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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
CAMBER SPINE/MEDICAL TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
CUTTING EDGE SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
GENESYS SPINE
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS
  SUBSTANTIALLY EQUIVALENT 1
L&K BIOMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
LIFE SPINE
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC SOFAMOR DANEK
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX
  SUBSTANTIALLY EQUIVALENT 2
ORTHOFIX INC.
  SUBSTANTIALLY EQUIVALENT 2
SI-BONE, INC.
  SUBSTANTIALLY EQUIVALENT 8
SI-TECHNOLOGY, LLC
  SUBSTANTIALLY EQUIVALENT 1
SPINEFRONTIER INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINEFRONTIER, INC.
  SUBSTANTIALLY EQUIVALENT 1
SURGICAL INSTRUMENT MANUFACTURERS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ZYGA TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Malposition of Device 374
Adverse Event Without Identified Device or Use Problem 224
Loss of Osseointegration 52
Failure to Osseointegrate 25
Inadequacy of Device Shape and/or Size 24
Insufficient Information 8
Device Handling Problem 7
Break 4
Device Damaged by Another Device 4
Difficult to Remove 4
Use of Device Problem 3
Migration or Expulsion of Device 2
Patient Device Interaction Problem 2
Loosening of Implant Not Related to Bone-Ingrowth 1
Difficult to Advance 1
Tip 1
Fracture 1
Improper or Incorrect Procedure or Method 1
Difficult to Insert 1
Total Device Problems 739


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