Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 8
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 3
GS MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
ICOTEC AG
  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 11
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 2
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 3
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
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 826 826

Device Problems MDRs with this Device Problem Events in those MDRs
Break 632 635
Migration 482 485
Adverse Event Without Identified Device or Use Problem 372 373
Fracture 330 339
Mechanical Problem 316 316
Device-Device Incompatibility 266 267
Compatibility Problem 121 121
Material Deformation 110 111
Insufficient Information 103 105
Mechanics Altered 102 102
Material Integrity Problem 73 73
Mechanical Jam 64 64
Collapse 64 64
Use of Device Problem 58 58
Migration or Expulsion of Device 52 52
Patient Device Interaction Problem 51 51
Appropriate Term/Code Not Available 49 49
Detachment of Device or Device Component 37 37
Material Twisted/Bent 36 36
Material Fragmentation 32 32
Device Dislodged or Dislocated 31 31
Device Sensing Problem 20 20
Difficult to Insert 18 19
Malposition of Device 18 18
Improper or Incorrect Procedure or Method 17 17
Incorrect, Inadequate or Imprecise Result or Readings 16 16
Entrapment of Device 15 15
Loosening of Implant Not Related to Bone-Ingrowth 13 13
No Apparent Adverse Event 13 13
Naturally Worn 12 12
Unintended Movement 11 11
Crack 10 10
Difficult to Advance 9 9
Manufacturing, Packaging or Shipping Problem 9 9
Physical Resistance/Sticking 9 9
Activation Failure 9 9
Product Quality Problem 9 9
Difficult to Remove 8 8
Device Slipped 8 8
Activation Problem 7 7
Positioning Problem 7 7
Osseointegration Problem 7 7
Expulsion 7 7
Activation, Positioning or Separation Problem 7 7
Difficult or Delayed Positioning 7 7
Failure to Eject 6 6
Device Damaged by Another Device 6 6
Device Handling Problem 6 6
Human-Device Interface Problem 5 5
Contamination /Decontamination Problem 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2129 2143
Insufficient Information 292 299
Pain 267 269
Failure of Implant 108 108
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 80 80
Unspecified Infection 79 79
Nerve Damage 77 78
Foreign Body In Patient 67 67
Non-union Bone Fracture 65 65
Unspecified Tissue Injury 62 63
Device Embedded In Tissue or Plaque 60 60
Osteolysis 54 54
Joint Laxity 38 38
Post Operative Wound Infection 38 38
Hematoma 37 37
Inadequate Osseointegration 30 30
Bone Fracture(s) 30 30
Unspecified Nervous System Problem 29 29
Hemorrhage/Bleeding 25 25
Neuropathy 23 23
Numbness 23 23
Laceration(s) 22 22
Vertebral Fracture 19 19
Spinal Cord Injury 19 19
Intervertebral Disc Compression or Protrusion 18 18
Perforation of Vessels 17 17
Cerebrospinal Fluid Leakage 16 16
Unspecified Musculoskeletal problem 16 16
Stenosis 14 14
Ambulation Difficulties 13 13
Paralysis 13 13
Muscle Weakness 13 13
Spinal Column Injury 12 12
Discomfort 10 10
Pulmonary Embolism 9 10
Arthritis 9 9
Dysphagia/ Odynophagia 8 8
Fall 8 8
Impaired Healing 8 8
Hypersensitivity/Allergic reaction 8 8
Wound Dehiscence 7 7
Paresthesia 7 7
Bacterial Infection 7 7
Implant Pain 6 6
Sleep Dysfunction 6 6
Decreased Sensitivity 6 6
Speech Disorder 6 6
Neck Pain 6 6
Swelling/ Edema 5 5
No Consequences Or Impact To Patient 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
-
-