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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 2
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
BAAT MEDICAL PRODUCTS BV
  SUBSTANTIALLY EQUIVALENT 1
BAUI BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BENVENUE MEDICAL, INC.
  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 1
CARLSMED, INC.
  SUBSTANTIALLY EQUIVALENT 6
CHANGZHOU GEASURE MEDICAL APPARATUS AND INSTRUMENTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
CHOICESPINE, 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 3
EXPANDING INNOVATIONS, INC.
  SUBSTANTIALLY EQUIVALENT 2
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 3
GLOBUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
GS MEDICAL CO. LTD.
  SUBSTANTIALLY EQUIVALENT 2
ICOTEC AG
  SUBSTANTIALLY EQUIVALENT 1
INNOVASIS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTEGRITY IMPLANTS INC
  SUBSTANTIALLY EQUIVALENT 1
INTEGRITY IMPLANTS INC.
  SUBSTANTIALLY EQUIVALENT 4
INTELIVATION LLC
  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 4
LIFE SPINE INC.
  SUBSTANTIALLY EQUIVALENT 4
LIFE SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 10
MEDACTA INERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL S .A.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1
MEDICREA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 1
MEDICREA INTERNATIONAL S.A.S. (MEDTRONIC)
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL SÀRL
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL, SARL
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC SOFAMOR DANEK
  SUBSTANTIALLY EQUIVALENT 1
  1.  K211258  Endoskeleton TC Interbody System, Endoskeleton TCS ...
  2.  K212524  Anteralign Spinal System with Titan nanoLOCK Surfa ...
  3.  K212653  Catalyft LS Expandable Interbody System
  4.  K223153  Catalyft LS Expandable Interbody System with Titan ...
MEDTRONIC SOFAMOR DANEK USA
  SUBSTANTIALLY EQUIVALENT 1
  1.  K211258  Endoskeleton TC Interbody System, Endoskeleton TCS ...
  2.  K212524  Anteralign Spinal System with Titan nanoLOCK Surfa ...
  3.  K212653  Catalyft LS Expandable Interbody System
  4.  K223153  Catalyft LS Expandable Interbody System with Titan ...
MEDTRONIC SOFAMOR DANEK USA, INC
  SUBSTANTIALLY EQUIVALENT 1
  1.  K211258  Endoskeleton TC Interbody System, Endoskeleton TCS ...
  2.  K212524  Anteralign Spinal System with Titan nanoLOCK Surfa ...
  3.  K212653  Catalyft LS Expandable Interbody System
  4.  K223153  Catalyft LS Expandable Interbody System with Titan ...
MEDTRONIC SOFAMOR DANEK USA, INC.
  SUBSTANTIALLY EQUIVALENT 4
  1.  K211258  Endoskeleton TC Interbody System, Endoskeleton TCS ...
  2.  K212524  Anteralign Spinal System with Titan nanoLOCK Surfa ...
  3.  K212653  Catalyft LS Expandable Interbody System
  4.  K223153  Catalyft LS Expandable Interbody System with Titan ...
MEDTRONIC SOFAMOR DANEK, USA INC.
  SUBSTANTIALLY EQUIVALENT 3
MEDYSSEY USA, INC.
  SUBSTANTIALLY EQUIVALENT 2
MET ONE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
MET ONE TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
MIRUS, LLC
  SUBSTANTIALLY EQUIVALENT 2
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
NUVASIVE, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 9
NVISION BIOMEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
OC MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 1
OMNIA MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX US LLC
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
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 1
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 1
SPINEART SA
  SUBSTANTIALLY EQUIVALENT 1
SPINEEX, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINEFRONTIER, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINEOLOGY INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINEVISION SAS
  SUBSTANTIALLY EQUIVALENT 1
SPINEVISION, S.A.S.
  SUBSTANTIALLY EQUIVALENT 1
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 3
ZAVATION MEDICAL PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 3
ZHEJIANG DECANS MEDICAL DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZS FAB INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 640 640
2021 621 621
2022 618 623
2023 578 578
2024 733 733
2025 337 337

Device Problems MDRs with this Device Problem Events in those MDRs
Break 750 750
Migration 501 501
Adverse Event Without Identified Device or Use Problem 452 452
Fracture 303 307
Device-Device Incompatibility 291 291
Mechanical Problem 235 235
Compatibility Problem 135 135
Insufficient Information 101 101
Material Deformation 93 94
Mechanics Altered 90 90
Material Integrity Problem 85 85
Migration or Expulsion of Device 63 63
Mechanical Jam 62 62
Use of Device Problem 54 54
Appropriate Term/Code Not Available 54 54
Material Twisted/Bent 53 53
Collapse 53 53
Patient Device Interaction Problem 50 50
Device Dislodged or Dislocated 34 34
Detachment of Device or Device Component 33 33
Material Fragmentation 30 30
Loosening of Implant Not Related to Bone-Ingrowth 22 22
Malposition of Device 20 20
Difficult to Insert 19 20
Device Sensing Problem 19 19
Improper or Incorrect Procedure or Method 17 17
Physical Resistance/Sticking 17 17
Crack 15 15
No Apparent Adverse Event 15 15
Entrapment of Device 12 12
Incorrect, Inadequate or Imprecise Result or Readings 11 11
Unintended Movement 11 11
Device Slipped 11 11
Positioning Problem 10 10
Product Quality Problem 10 10
Difficult to Advance 9 9
Activation Failure 9 9
Device Damaged by Another Device 8 8
Device Handling Problem 7 7
Expulsion 7 7
Activation, Positioning or Separation Problem 7 7
Difficult or Delayed Positioning 7 7
Manufacturing, Packaging or Shipping Problem 6 6
Difficult to Remove 6 6
Contamination /Decontamination Problem 6 6
Failure to Eject 6 6
Inaccurate Information 6 6
Osseointegration Problem 6 6
Material Separation 6 6
Human-Device Interface Problem 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1870 1875
Pain 318 318
Insufficient Information 280 280
No Known Impact Or Consequence To Patient 176 176
No Consequences Or Impact To Patient 131 131
Failure of Implant 122 122
Unspecified Infection 93 93
No Code Available 81 81
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 78 78
Foreign Body In Patient 75 75
Nerve Damage 75 75
Device Embedded In Tissue or Plaque 72 72
Non-union Bone Fracture 64 64
Unspecified Tissue Injury 62 62
Osteolysis 55 55
Hematoma 45 45
Post Operative Wound Infection 42 42
Bone Fracture(s) 36 36
Joint Laxity 36 36
Neuropathy 26 26
Unspecified Nervous System Problem 24 24
Laceration(s) 23 23
Hemorrhage/Bleeding 22 22
Spinal Cord Injury 21 21
Numbness 21 21
Cerebrospinal Fluid Leakage 21 21
Inadequate Osseointegration 19 19
Perforation of Vessels 18 18
Vertebral Fracture 17 17
Stenosis 17 17
Injury 16 16
Unspecified Musculoskeletal problem 14 14
Intervertebral Disc Compression or Protrusion 14 14
Ambulation Difficulties 13 13
Paralysis 13 13
Spinal Column Injury 13 13
Wound Dehiscence 13 13
Hypersensitivity/Allergic reaction 12 12
Arthritis 11 11
Muscle Weakness 11 11
Pulmonary Embolism 10 10
Dysphagia/ Odynophagia 10 10
No Patient Involvement 10 10
Fall 10 10
Discomfort 9 9
Weakness 9 9
Tissue Damage 9 9
Neck Pain 8 8
Cyst(s) 8 8
Bacterial Infection 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 Mar-21-2025
13 Stryker Spine II Apr-20-2021
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