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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 9
AMPLIFY SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
ARTFX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ASTURA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ASTURA MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
ATLAS SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAAT MEDICAL PRODUCTS B.V.
  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 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
CORELINK, LLC
  SUBSTANTIALLY EQUIVALENT 1
CTL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
CURITEVA, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEGEN MEDICAL
  SUBSTANTIALLY EQUIVALENT 4
DEGEN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ELLIQUENCE, LLC
  SUBSTANTIALLY EQUIVALENT 1
EMINENT SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
ENZTEC LIMITED
  SUBSTANTIALLY EQUIVALENT 4
EXPANDING INNOVATIONS, INC.
  SUBSTANTIALLY EQUIVALENT 6
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
IMPLANET
  SUBSTANTIALLY EQUIVALENT 1
INTEGRITY IMPLANTS INC. DBA ACCELUS
  SUBSTANTIALLY EQUIVALENT 1
INTEGRITY IMPLANTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
INTELIVATION, LLC
  SUBSTANTIALLY EQUIVALENT 1
JEIL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
JOIMAX GMBH
  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 12
MEDACTA INERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 2
MEDICREA INTERNATIONAL S.A.S. (MEDTRONIC)
  SUBSTANTIALLY EQUIVALENT 2
MEDOS INTERNATIONAL SARL
  SUBSTANTIALLY EQUIVALENT 2
MEDOS INTERNATIONAL SÀRL
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC SOFAMOR DANEK USA
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC SOFAMOR DANEK USA, INC.
  SUBSTANTIALLY EQUIVALENT 7
MEDYSSEY USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
MET ONE TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
MIRUS, LLC
  SUBSTANTIALLY EQUIVALENT 1
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
NGMEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 3
NU VASIVE, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 5
NVISION BIOMEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
OC MEDICAL DEVICES
  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
PRECISION SPINE, INC.
  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 9
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
SPINE INNOVATION, LLC
  SUBSTANTIALLY EQUIVALENT 1
SPINE WAVE, INC.
  SUBSTANTIALLY EQUIVALENT 2
SPINEART SA
  SUBSTANTIALLY EQUIVALENT 1
SPINEOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINEVISION, S.A.S.
  SUBSTANTIALLY EQUIVALENT 2
SPINEWORXX AG
  SUBSTANTIALLY EQUIVALENT 1
TDM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VY SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 4
XENIX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ZAVATION MEDICAL PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 4
ZHEJIANG DECANS MEDICAL DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZSFAB, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2021 622 627
2022 618 630
2023 576 578
2024 729 731
2025 827 827
2026 240 240

Device Problems MDRs with this Device Problem Events in those MDRs
Break 696 699
Migration 510 513
Adverse Event Without Identified Device or Use Problem 386 387
Fracture 366 375
Mechanical Problem 364 364
Device-Device Incompatibility 276 277
Compatibility Problem 121 121
Material Deformation 121 122
Mechanics Altered 105 105
Insufficient Information 103 105
Collapse 75 75
Material Integrity Problem 74 74
Mechanical Jam 71 71
Use of Device Problem 63 63
Migration or Expulsion of Device 53 53
Patient Device Interaction Problem 51 51
Appropriate Term/Code Not Available 49 49
Detachment of Device or Device Component 38 38
Material Twisted/Bent 36 36
Device Dislodged or Dislocated 35 35
Material Fragmentation 32 32
Device Sensing Problem 22 22
Difficult to Insert 19 20
Incorrect, Inadequate or Imprecise Result or Readings 18 18
Malposition of Device 18 18
Improper or Incorrect Procedure or Method 17 17
Entrapment of Device 16 16
Loosening of Implant Not Related to Bone-Ingrowth 15 15
No Apparent Adverse Event 13 13
Naturally Worn 12 12
Unintended Movement 11 11
Crack 10 10
Product Quality Problem 9 9
Manufacturing, Packaging or Shipping Problem 9 9
Difficult to Advance 9 9
Activation Failure 9 9
Physical Resistance/Sticking 9 9
Activation, Positioning or Separation Problem 8 8
Difficult to Remove 8 8
Device Slipped 8 8
Difficult or Delayed Positioning 7 7
Expulsion 7 7
Activation Problem 7 7
Positioning Problem 7 7
Osseointegration Problem 7 7
Device Handling Problem 6 6
Failure to Eject 6 6
Human-Device Interface Problem 6 6
Device Damaged by Another Device 6 6
Contamination /Decontamination Problem 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2319 2333
Insufficient Information 302 309
Pain 275 277
Failure of Implant 114 114
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 82 82
Unspecified Infection 81 81
Nerve Damage 77 78
Foreign Body In Patient 72 72
Non-union Bone Fracture 69 69
Device Embedded In Tissue or Plaque 63 63
Unspecified Tissue Injury 62 63
Osteolysis 56 56
Hematoma 39 39
Post Operative Wound Infection 38 38
Joint Laxity 38 38
Unspecified Nervous System Problem 32 32
Bone Fracture(s) 32 32
Inadequate Osseointegration 30 30
Neuropathy 25 25
Hemorrhage/Bleeding 25 25
Numbness 23 23
Laceration(s) 22 22
Vertebral Fracture 20 20
Spinal Cord Injury 19 19
Intervertebral Disc Compression or Protrusion 19 19
Perforation of Vessels 18 18
Cerebrospinal Fluid Leakage 17 17
Unspecified Musculoskeletal problem 16 16
Paralysis 14 14
Stenosis 14 14
Muscle Weakness 14 14
Ambulation Difficulties 13 13
Spinal Column Injury 13 13
Hypersensitivity/Allergic reaction 12 12
Discomfort 10 10
Pulmonary Embolism 9 10
Arthritis 9 9
Impaired Healing 8 8
Fall 8 8
Wound Dehiscence 8 8
Dysphagia/ Odynophagia 8 8
Bacterial Infection 7 7
Paresthesia 7 7
Implant Pain 6 6
Sleep Dysfunction 6 6
Cramp(s) /Muscle Spasm(s) 6 6
Decreased Sensitivity 6 6
Neck Pain 6 6
Speech Disorder 6 6
Skin Inflammation/ Irritation 5 5

Recalls
Manufacturer Recall Class Date Posted
1 Advanced Research Medical, LLC II Apr-29-2024
2 Alphatec Spine, Inc. II Jan-30-2025
3 CoreLink LLC II Jan-12-2023
4 DePuy Spine, Inc. II Jul-01-2022
5 Innovasis, Inc II Sep-17-2024
6 K2M, Inc II Jun-01-2021
7 Medicrea International II Jan-09-2026
8 Medicrea International II Aug-24-2023
9 Medtronic Sofamor Danek USA Inc II Nov-21-2025
10 Medtronic Sofamor Danek USA, Inc II Apr-20-2021
11 Orthofix U.S. LLC III Dec-11-2025
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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