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


Premarket Reviews
ManufacturerDecision
4WEB MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ACUITY SURGICAL DEVICES, LLC
  SUBSTANTIALLY EQUIVALENT 3
ADCURA, INC.
  SUBSTANTIALLY EQUIVALENT 1
AEGIS SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 2
ALPHATEC SPINE
  SUBSTANTIALLY EQUIVALENT 2
ALPHATEC SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 10
AMPLIFY SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
ARTFX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ASTURA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ASTURA MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 2
ATLAS SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAAT MEDICAL PRODUCTS B.V.
  SUBSTANTIALLY EQUIVALENT 1
BAUI BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BENVENUE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BETHESDA MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 1
BIOGEND THERAPEUTICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CAMBER SPINE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 2
CAMBER SPINE TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
CARBOFIX ORTHOPEDICS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
CARBOFIX ORTHPEDICS , LTD.
  SUBSTANTIALLY EQUIVALENT 1
CARLSMED
  SUBSTANTIALLY EQUIVALENT 1
CARLSMED, INC.
  SUBSTANTIALLY EQUIVALENT 9
CG MEDTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CHANGZHOU GEASURE MEDICAL APPARATUS AND INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CHOICE SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
CLARIANCE
  SUBSTANTIALLY EQUIVALENT 2
CLARIANCE, SAS
  SUBSTANTIALLY EQUIVALENT 1
CORELINK, LLC
  SUBSTANTIALLY EQUIVALENT 1
CTL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
CURITEVA, INC.
  SUBSTANTIALLY EQUIVALENT 1
CUTTING EDGE SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 3
DEGEN MEDICAL
  SUBSTANTIALLY EQUIVALENT 5
DEGEN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
EIT EMERGING IMPLANT TECHNOLOGIES GMBH
  SUBSTANTIALLY EQUIVALENT 1
ELLIQUENCE, LLC
  SUBSTANTIALLY EQUIVALENT 1
EMINENT SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
ENZTEC LIMITED
  SUBSTANTIALLY EQUIVALENT 4
EXPANDING INNOVATIONS, INC.
  SUBSTANTIALLY EQUIVALENT 7
FLOSPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
GBS COMMONWEALTH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GENESYS SPINE
  SUBSTANTIALLY EQUIVALENT 1
GETSET SURGICAL, SA
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
GS MEDICAL CO. , LTD.
  SUBSTANTIALLY EQUIVALENT 2
ICOTEC AG
  SUBSTANTIALLY EQUIVALENT 1
INNOVASIS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTEGRITY IMPLANTS INC. DBA ACCELUS
  SUBSTANTIALLY EQUIVALENT 1
INTEGRITY IMPLANTS, INC.
  SUBSTANTIALLY EQUIVALENT 5
INTELIVATION, LLC
  SUBSTANTIALLY EQUIVALENT 1
JEIL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
JOIMAX GMBH
  SUBSTANTIALLY EQUIVALENT 1
K2M,INC.
  SUBSTANTIALLY EQUIVALENT 1
KALITEC MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
KYOCERA MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
L & K BIOMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
LIFE SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 15
MEDACTA INERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL S .A.
  SUBSTANTIALLY EQUIVALENT 3
MEDICREA INTERNATIONAL S.A.S. (MEDTRONIC)
  SUBSTANTIALLY EQUIVALENT 1
MEDICREA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL SARL
  SUBSTANTIALLY EQUIVALENT 2
MEDOS INTERNATIONAL SÀRL
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC SOFAMOR DANEK
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC SOFAMOR DANEK USA
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC SOFAMOR DANEK USA, INC.
  SUBSTANTIALLY EQUIVALENT 9
MEDYSSEY USA, INC.
  SUBSTANTIALLY EQUIVALENT 2
MET ONE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
MET ONE TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
MIRUS, LLC
  SUBSTANTIALLY EQUIVALENT 2
MOBARN MEDICAL DEVICES, LLC
  SUBSTANTIALLY EQUIVALENT 1
NANOHIVE MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
NANOVIS, LLC
  SUBSTANTIALLY EQUIVALENT 1
NEXT ORTHOSURGICAL
  SUBSTANTIALLY EQUIVALENT 1
NEXUS SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
NEXXT SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 3
NGMEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 2
NU VASIVE, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 9
NVISION BIOMEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
OC MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 1
OMNIA MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX US, LLC
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX, INC.
  SUBSTANTIALLY EQUIVALENT 2
PANTHEON SPINAL
  SUBSTANTIALLY EQUIVALENT 1
PARADIGM SPINE GMBH
  SUBSTANTIALLY EQUIVALENT 1
PRECISION SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
PRINTERPREZZ
  SUBSTANTIALLY EQUIVALENT 1
PRISM SURGICAL DESIGNS PTY, LTD.
  SUBSTANTIALLY EQUIVALENT 1
RAED M. ALI, M.D., INC.
  SUBSTANTIALLY EQUIVALENT 1
RESTOR3D
  SUBSTANTIALLY EQUIVALENT 2
RETROPSOAS TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
SEASPINE ORTHOPEDICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 14
SHANGHAI IATRICAL-TI TECHNOLOGIES CO , LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI REACH MEDICAL INSTRUMENT CO, LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI SANYOU MEDICAL CO, LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHENZHEN DAZHOU MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SIGNUS MEDIZINTECHNIK
  SUBSTANTIALLY EQUIVALENT 1
SIGNUS MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 1
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SOUTHERN MEDICAL (PTY) , LTD.
  SUBSTANTIALLY EQUIVALENT 1
SOUTHERN SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
SPECTRUM SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 2
SPECTRUM SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
SPINAL ELEMENTS
  SUBSTANTIALLY EQUIVALENT 1
SPINAL ELEMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 4
SPINAL STABILITY, LLC
  SUBSTANTIALLY EQUIVALENT 1
SPINE WAVE, INC.
  SUBSTANTIALLY EQUIVALENT 2
SPINEART SA
  SUBSTANTIALLY EQUIVALENT 1
SPINEEX, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINEFRONTIER, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINEOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINEVISION, S.A.S.
  SUBSTANTIALLY EQUIVALENT 2
SPINEWORXX AG
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TDM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VY SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 4
ZAVATION MEDICAL PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 6
ZHEJIANG DECANS MEDICAL DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZSFAB, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2020 640 640
2021 622 627
2022 618 630
2023 576 578
2024 729 731
2025 762 762

Device Problems MDRs with this Device Problem Events in those MDRs
Break 805 808
Migration 559 562
Adverse Event Without Identified Device or Use Problem 468 469
Fracture 360 369
Mechanical Problem 330 330
Device-Device Incompatibility 327 328
Compatibility Problem 136 136
Material Deformation 122 123
Insufficient Information 106 108
Mechanics Altered 104 104
Material Integrity Problem 91 91
Mechanical Jam 70 70
Migration or Expulsion of Device 66 66
Collapse 64 64
Use of Device Problem 63 63
Material Twisted/Bent 56 56
Appropriate Term/Code Not Available 54 54
Patient Device Interaction Problem 52 52
Detachment of Device or Device Component 44 44
Material Fragmentation 40 40
Device Dislodged or Dislocated 38 38
Malposition of Device 24 24
Loosening of Implant Not Related to Bone-Ingrowth 22 22
Difficult to Insert 21 22
Device Sensing Problem 21 21
Improper or Incorrect Procedure or Method 17 17
Physical Resistance/Sticking 17 17
No Apparent Adverse Event 17 17
Incorrect, Inadequate or Imprecise Result or Readings 16 16
Entrapment of Device 15 15
Crack 15 15
Device Slipped 12 12
Naturally Worn 12 12
Unintended Movement 11 11
Product Quality Problem 10 10
Manufacturing, Packaging or Shipping Problem 10 10
Positioning Problem 10 10
Device Damaged by Another Device 9 9
Difficult to Advance 9 9
Activation Failure 9 9
Difficult to Remove 8 8
Activation Problem 7 7
Osseointegration Problem 7 7
Difficult or Delayed Positioning 7 7
Expulsion 7 7
Activation, Positioning or Separation Problem 7 7
Device Handling Problem 7 7
Contamination /Decontamination Problem 6 6
Imprecision 6 7
Failure to Eject 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2180 2194
Pain 344 346
Insufficient Information 298 305
No Known Impact Or Consequence To Patient 176 176
Failure of Implant 134 134
No Consequences Or Impact To Patient 131 131
Unspecified Infection 100 100
Foreign Body In Patient 81 81
No Code Available 81 81
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 80 80
Nerve Damage 79 80
Device Embedded In Tissue or Plaque 76 76
Non-union Bone Fracture 68 68
Unspecified Tissue Injury 67 68
Osteolysis 55 55
Hematoma 46 46
Post Operative Wound Infection 42 42
Joint Laxity 38 38
Bone Fracture(s) 37 37
Neuropathy 32 32
Inadequate Osseointegration 32 32
Unspecified Nervous System Problem 29 29
Hemorrhage/Bleeding 28 28
Numbness 25 25
Cerebrospinal Fluid Leakage 25 25
Laceration(s) 23 23
Spinal Cord Injury 21 21
Vertebral Fracture 19 19
Perforation of Vessels 18 18
Stenosis 17 17
Intervertebral Disc Compression or Protrusion 17 17
Ambulation Difficulties 16 16
Injury 16 16
Unspecified Musculoskeletal problem 15 15
Fall 14 14
Spinal Column Injury 14 14
Paralysis 13 13
Muscle Weakness 13 13
Hypersensitivity/Allergic reaction 13 13
Wound Dehiscence 13 13
Discomfort 11 11
Pulmonary Embolism 11 12
Cyst(s) 11 11
Arthritis 11 11
Dysphagia/ Odynophagia 10 10
No Patient Involvement 10 10
Weakness 9 9
Impaired Healing 9 9
Tissue Damage 9 9
Sepsis 8 8

Recalls
Manufacturer Recall Class Date Posted
1 Advanced Research Medical, LLC II Apr-29-2024
2 Alphatec Spine, Inc. II Jan-30-2025
3 CTL Medical Corporation II Jul-04-2020
4 CoreLink LLC II Jan-12-2023
5 DePuy Spine, Inc. II Jul-01-2022
6 Globus Medical, Inc. II Aug-22-2020
7 Innovasis, Inc II Sep-17-2024
8 K2M, Inc II Jun-01-2021
9 Medicrea International II Aug-24-2023
10 Medicrea International II Feb-12-2020
11 Medtronic Sofamor Danek USA, Inc II Apr-20-2021
12 Orthofix U.S. LLC II Sep-11-2025
13 Orthofix U.S. LLC II Mar-21-2025
14 SEASPINE ORTHOPEDICS CORPORATION II Sep-11-2025
15 Stryker Spine II Apr-20-2021
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