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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device intervertebral fusion device with bone graft, cervical
Regulation Description Intervertebral body fusion device.
Definition Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
Product CodeODP
Regulation Number 888.3080
Device Class 2


Premarket Reviews
ManufacturerDecision
4WEB MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ACRO COMPOSITES, LLC
  SUBSTANTIALLY EQUIVALENT 1
ACUITY SURGICAL DEVICES, LLC
  SUBSTANTIALLY EQUIVALENT 1
ALPHATEC SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 2
ARTFX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
AURORA SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
BLUSTONE SYNERGY, LLC
  SUBSTANTIALLY EQUIVALENT 1
CARBOFIX ORTHPEDICS , LTD.
  SUBSTANTIALLY EQUIVALENT 1
CARLSMED, INC.
  SUBSTANTIALLY EQUIVALENT 2
CORELINK, LLC
  SUBSTANTIALLY EQUIVALENT 1
CTL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
CURITEVA, INC.
  SUBSTANTIALLY EQUIVALENT 3
CUTTING EDGE SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
DEGEN MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
DEPUY SPINE
  SUBSTANTIALLY EQUIVALENT 1
EFFORTMED, LLC
  SUBSTANTIALLY EQUIVALENT 1
EMINENT SPINE
  SUBSTANTIALLY EQUIVALENT 1
FLOSPINE
  SUBSTANTIALLY EQUIVALENT 1
G SURGICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
GBS COMMONWEALTH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 7
GLOBUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
GS MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HAPPE SPINE
  SUBSTANTIALLY EQUIVALENT 1
HC BIOLOGICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
HT MEDICAL D.B.A. XENIX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
IMPLANET, S.A.
  SUBSTANTIALLY EQUIVALENT 1
INNOVASIS, INC.
  SUBSTANTIALLY EQUIVALENT 3
INTEGRITY SPINE
  SUBSTANTIALLY EQUIVALENT 1
INTELIVATION TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
JEIL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
JMT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
K&J CONSULTING
  SUBSTANTIALLY EQUIVALENT 1
K&J CONSULTING CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
KAHTNU SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
KEOS
  SUBSTANTIALLY EQUIVALENT 1
L&K BIOMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
LINCOTEK MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
LNTELIVATION, LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDYNUS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MET ONE TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
MIKRON MAKINA SANAYI VE TIC. LTD. STI.
  SUBSTANTIALLY EQUIVALENT 1
NANOHIVE MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
NANOVIS, LLC
  SUBSTANTIALLY EQUIVALENT 1
NEXUS SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
NGMEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 4
NU VASIVE, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
NUVASIVE, INC.
  SUBSTANTIALLY EQUIVALENT 1
NVISION BIOMEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX, INC.
  SUBSTANTIALLY EQUIVALENT 2
ORTHOMOD, LLC
  SUBSTANTIALLY EQUIVALENT 1
OSTEOMNI, INC.
  SUBSTANTIALLY EQUIVALENT 1
PAONAN BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PARADIGM SPINE
  SUBSTANTIALLY EQUIVALENT 1
PRECISION SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
RELIANCE MEDICAL SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
SAPPHIRE MEDICAL GROUP
  SUBSTANTIALLY EQUIVALENT 1
SEASPINE ORTHOPEDICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SOUTHERN MEDICAL (PTY) , LTD.
  SUBSTANTIALLY EQUIVALENT 1
SPECTRUM SPINE
  SUBSTANTIALLY EQUIVALENT 1
SPECTRUM SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINAL ELEMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINEART SA
  SUBSTANTIALLY EQUIVALENT 1
SPINECRAFT
  SUBSTANTIALLY EQUIVALENT 1
SPINECRAFT, LLC
  SUBSTANTIALLY EQUIVALENT 1
SPINEPOINT, LLC
  SUBSTANTIALLY EQUIVALENT 1
STRYKER SPINE
  SUBSTANTIALLY EQUIVALENT 1
SYNC SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
ULRICH MEDICAL USA
  SUBSTANTIALLY EQUIVALENT 1
ULRICH MEDICAL USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
VY SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 5
WENZEL SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
XENCO MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
ZAVATION MEDICAL PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG DECANS MEDICAL DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZSFAB
  SUBSTANTIALLY EQUIVALENT 1
ZSFAB, INC.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2021 161 161
2022 50 50
2023 36 36
2024 55 55
2025 57 57
2026 18 18

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 179 179
Migration 48 48
Fracture 24 24
Patient Device Interaction Problem 21 21
Break 19 19
No Apparent Adverse Event 12 12
Corroded 8 8
Insufficient Information 7 7
Device-Device Incompatibility 6 6
Migration or Expulsion of Device 6 6
Device Slipped 5 5
Appropriate Term/Code Not Available 5 5
Malposition of Device 5 5
Material Deformation 5 5
Patient-Device Incompatibility 5 5
Material Fragmentation 5 5
Detachment of Device or Device Component 4 4
Loosening of Implant Not Related to Bone-Ingrowth 4 4
Material Integrity Problem 4 4
Physical Resistance/Sticking 3 3
Mechanical Problem 3 3
Device Dislodged or Dislocated 3 3
Unintended System Motion 3 3
Device Appears to Trigger Rejection 3 3
Loss of or Failure to Bond 3 3
Contamination /Decontamination Problem 2 2
Unintended Movement 2 2
Use of Device Problem 2 2
Solder Joint Fracture 2 2
Illegible Information 2 2
Expulsion 2 2
Flaked 2 2
Manufacturing, Packaging or Shipping Problem 1 1
Expiration Date Error 1 1
Material Twisted/Bent 1 1
Mechanics Altered 1 1
Collapse 1 1
Device Markings/Labelling Problem 1 1
Device Handling Problem 1 1
Peeled/Delaminated 1 1
Compatibility Problem 1 1
Human-Device Interface Problem 1 1
Inaccurate Information 1 1
Premature Separation 1 1
Activation, Positioning or Separation Problem 1 1
Loose or Intermittent Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 96 96
Pain 83 83
Dysphagia/ Odynophagia 56 56
Non-union Bone Fracture 27 27
Insufficient Information 26 26
Neck Pain 24 24
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 22 22
Failure of Implant 21 21
Nerve Damage 21 21
Numbness 17 17
Inadequate Pain Relief 17 17
Unspecified Infection 12 12
Hematoma 12 12
Physical Asymmetry 12 12
Swelling/ Edema 12 12
Unspecified Tissue Injury 12 12
Post Operative Wound Infection 11 11
Osteolysis 10 10
Bone Fracture(s) 10 10
Fatigue 9 9
Fall 8 8
Intervertebral Disc Compression or Protrusion 7 7
Muscular Rigidity 7 7
Fluid Discharge 6 6
Vertebral Fracture 6 6
Spinal Cord Injury 5 5
Implant Pain 5 5
Thrombosis/Thrombus 5 5
Hypersensitivity/Allergic reaction 4 4
Metal Related Pathology 4 4
Inflammation 4 4
Muscle Weakness 4 4
Perforation of Vessels 4 4
Cerebrospinal Fluid Leakage 4 4
Paresthesia 4 4
Discomfort 3 3
Limb Fracture 3 3
Stenosis 3 3
Cramp(s) /Muscle Spasm(s) 3 3
No Consequences Or Impact To Patient 3 3
Nervous System Injury 3 3
Decreased Sensitivity 3 3
Pulmonary Embolism 3 3
Impaired Healing 3 3
Ambulation Difficulties 3 3
Joint Laxity 2 2
Neck Stiffness 2 2
Arthritis 2 2
Low Blood Pressure/ Hypotension 2 2
Quadriplegia 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Medicrea International II Aug-24-2023
2 Orthofix U.S. LLC III Dec-11-2025
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