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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
BEIJING FULE SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD.
  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
GLOBAL BIOMEDICA S.R.O.
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
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 14
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 9
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 10
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 5
SPINE INNOVATION, LLC
  SUBSTANTIALLY EQUIVALENT 1
SPINE WAVE, INC.
  SUBSTANTIALLY EQUIVALENT 3
SPINEART SA
  SUBSTANTIALLY EQUIVALENT 2
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 466 466

Device Problems MDRs with this Device Problem Events in those MDRs
Break 694 695
Migration 531 534
Fracture 406 415
Mechanical Problem 397 397
Adverse Event Without Identified Device or Use Problem 384 385
Device-Device Incompatibility 289 290
Material Deformation 144 145
Compatibility Problem 121 121
Mechanics Altered 111 111
Insufficient Device Problem Information 107 109
Collapse 84 84
Mechanical Jam 75 75
Material Integrity Problem 74 74
Use of Device Problem 63 63
Patient Device Interaction Problem 50 50
Migration or Expulsion of Device 44 44
Appropriate Device Problem Term/Code Not Available 43 43
Detachment of Device or Device Component 38 38
Material Twisted/Bent 36 36
Device Dislodged or Dislocated 36 36
Material Fragmentation 32 32
Device Sensing Problem 22 22
Incorrect, Inadequate or Imprecise Result or Readings 21 21
Malposition of Device 19 19
Loosening of Implant Not Related to Bone-Ingrowth 18 18
Difficult to Insert 18 19
No Apparent Adverse Event 15 15
Improper or Incorrect Procedure or Method 15 15
Naturally Worn 13 13
Crack 12 12
Physical Resistance/Sticking 12 12
Unintended Movement 12 12
Entrapment of Device 12 12
Difficult to Advance 10 10
Difficult to Remove 10 10
Activation Failure 9 9
Manufacturing, Packaging or Shipping Problem 9 9
Product Quality Problem 9 9
Difficult or Delayed Positioning 8 8
Osseointegration Problem 8 8
Expulsion 8 8
Activation, Positioning or Separation Problem 8 8
Device Slipped 8 8
Activation Problem 7 7
Human-Device Interface Problem 6 6
Material Separation 6 6
Device Handling Problem 6 6
Biocompatibility 6 6
Device Damaged by Another Device 6 6
Implant subsidence 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2504 2518
Insufficient Information 307 314
Pain 285 287
Failure of Implant 116 116
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 83 83
Unspecified Infection 81 81
Nerve Damage 78 79
Foreign Body In Patient 75 75
Nonunion/Delayed-union Bone Fracture 72 72
Device Embedded In Tissue or Plaque 68 68
Unspecified Tissue Injury 62 63
Osteolysis 56 56
Hematoma 39 39
Post Operative Wound Infection 38 38
Joint Laxity 38 38
Bone Fracture(s) 34 34
Inadequate Osseointegration 34 34
Unspecified Nervous System Problem 33 33
Back pain 33 33
Numbness 27 27
Neuropathy 26 26
Hemorrhage/Blood Loss/Bleeding 25 25
Laceration(s) 22 22
Intervertebral Disc Compression or Protrusion 20 20
Vertebral Fracture 20 20
Spinal Cord Injury 19 19
Perforation of Vessels 18 18
Cerebrospinal Fluid Leakage 18 18
Unspecified Musculoskeletal problem 17 17
Muscle Weakness/Atrophy 16 16
Stenosis 15 15
Ambulation or Postural Difficulties 14 14
Paralysis 14 14
Hypersensitivity/Allergic reaction 13 13
Spinal Column Injury 13 13
Limb Pain 12 12
Discomfort 10 10
Arthritis 9 9
Pulmonary Embolism 9 10
Dysphagia/ Odynophagia 8 8
Fall 8 8
Wound Dehiscence 8 8
Impaired Healing 8 8
Bacterial Infection 7 7
Paresthesia 7 7
Implant Pain 7 7
Speech Disorder 6 6
Cramp(s) /Muscle Spasm(s) 6 6
Dural Tear 6 7
Sleep Dysfunction 6 6

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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