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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device intervertebral fusion device with bone graft, lumbar
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 1
ALPHATEC SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 10
ALTUS PARTNERS, LLC
  SUBSTANTIALLY EQUIVALENT 1
AMPLIFY SURGICAL INC
  SUBSTANTIALLY EQUIVALENT 1
AMPLIFY SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
ASTURA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ASTURA MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 3
BAAT MEDICAL PRODUCTS BV
  SUBSTANTIALLY EQUIVALENT 1
BAUI BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BENVENUE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOGEND THERAPEUTICS CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
CAMBER SPINE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 3
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 5
CHANGZHOU GEASURE MEDICAL APPARATUS AND INSTRUMENTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
CHOICESPINE LLC
  SUBSTANTIALLY EQUIVALENT 1
CHOICESPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
CLARIANCE
  SUBSTANTIALLY EQUIVALENT 1
CLARIANCE SAS
  SUBSTANTIALLY EQUIVALENT 1
CLARIANCE, SAS
  SUBSTANTIALLY EQUIVALENT 1
CORELINK, LLC
  SUBSTANTIALLY EQUIVALENT 1
CTL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
CURITEVA, INC.
  SUBSTANTIALLY EQUIVALENT 1
CUTTING EDGE SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 3
DEGEN MEDICAL
  SUBSTANTIALLY EQUIVALENT 4
DEGEN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
DIFUSION TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
EIT EMERGING IMPLANT TECHNOLOGIES GMBH
  SUBSTANTIALLY EQUIVALENT 2
EMINENT SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
ENZTEC LIMITED
  SUBSTANTIALLY EQUIVALENT 4
EXPANDING INNOVATIONS, INC
  SUBSTANTIALLY EQUIVALENT 3
EXPANDING INNOVATIONS, INC.
  SUBSTANTIALLY EQUIVALENT 2
FIMS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
FLOSPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
GBS COMMONWEALTH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
GENESYS SPINE
  SUBSTANTIALLY EQUIVALENT 2
GLOBUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 4
GLOBUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
GS MEDICAL CO. LTD.
  SUBSTANTIALLY EQUIVALENT 2
ICOTEC AG
  SUBSTANTIALLY EQUIVALENT 1
INNOVASIS, INC.
  SUBSTANTIALLY EQUIVALENT 3
INTEGRITY IMPLANTS INC
  SUBSTANTIALLY EQUIVALENT 3
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 2
KEOS
  SUBSTANTIALLY EQUIVALENT 1
KUROS BIOSCIENCES BV
  SUBSTANTIALLY EQUIVALENT 1
KYOCERA MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
L&K BIOMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
LIFE SPINE INC.
  SUBSTANTIALLY EQUIVALENT 7
LIFE SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 7
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 4
MEDICREA INTERNATIONAL S.A.S. (MEDTRONIC)
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL SÀRL
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL, SARL
  SUBSTANTIALLY EQUIVALENT 3
MEDTRONIC SOFAMOR DANEK
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC SOFAMOR DANEK USA
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC SOFAMOR DANEK USA, INC
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC SOFAMOR DANEK USA, INC.
  SUBSTANTIALLY EQUIVALENT 5
MEDTRONIC SOFAMOR DANEK, USA INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDYSSEY USA, INC.
  SUBSTANTIALLY EQUIVALENT 3
MET ONE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
MET ONE TECHNOLOGIES, LLC
  SUBSTANTIALLY EQUIVALENT 1
MIRUS, LLC
  SUBSTANTIALLY EQUIVALENT 3
NANOHIVE MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
NANOVIS LLC
  SUBSTANTIALLY EQUIVALENT 1
NEO MEDICAL S.A.
  SUBSTANTIALLY EQUIVALENT 2
NEUROSTRUCTURES, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEXUS SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
NEXXT SPINE LLC
  SUBSTANTIALLY EQUIVALENT 4
NGMEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 2
NUVASIVE, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 10
NVISION BIOMEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
OC MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 1
OMNIA MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 2
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 2
PAONAN BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
PARADIGM SPINE, GMBH
  SUBSTANTIALLY EQUIVALENT 1
PIONEER SURGICAL TECHNOLOGY, INC. DBA RTI SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
PIONEER SURGICAL TECHNOLOGY, INC., DBA RTI SURGICAL, INC.
  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
RAED M. ALI, MD., INC.
  SUBSTANTIALLY EQUIVALENT 1
RELIANCE MEDICAL SYSTEMS LLC
  SUBSTANTIALLY EQUIVALENT 1
REPUBLIC SPINE LLC
  SUBSTANTIALLY EQUIVALENT 1
RESTOR3D
  SUBSTANTIALLY EQUIVALENT 2
SEASPINE ORTHOPEDICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 15
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
SIGNUS MEDIZINTECHNIK
  SUBSTANTIALLY EQUIVALENT 1
SIGNUS MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 1
SILONY MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
SOLCO BIOMEDICAL CO., LTD.
  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, LLC
  SUBSTANTIALLY EQUIVALENT 2
SPINAL ELEMENTS
  SUBSTANTIALLY EQUIVALENT 1
SPINAL ELEMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 4
SPINAL STABILITY, LLC
  SUBSTANTIALLY EQUIVALENT 1
SPINE WAVE, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINEEX INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINEEX, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINEFRONTIER, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINEOLOGY INC.
  SUBSTANTIALLY EQUIVALENT 2
SPINEVISION SAS
  SUBSTANTIALLY EQUIVALENT 1
SPINEVISION, S.A.S.
  SUBSTANTIALLY EQUIVALENT 1
SPINEWORXX AG
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
STRYKER SPINE
  SUBSTANTIALLY EQUIVALENT 1
TDM CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
TRANS1
  SUBSTANTIALLY EQUIVALENT 1
U&I CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
VY SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 2
WENZEL SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
XENCO MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
ZAVATION MEDICAL PRODUCTS LLC
  SUBSTANTIALLY EQUIVALENT 3
ZAVATION MEDICAL PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 4
ZS FAB INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 699 699
2020 640 640
2021 621 621
2022 618 623
2023 578 578
2024 466 466

Device Problems MDRs with this Device Problem Events in those MDRs
Break 878 878
Migration 528 528
Adverse Event Without Identified Device or Use Problem 478 478
Device-Device Incompatibility 308 308
Fracture 289 293
Mechanical Problem 137 137
Compatibility Problem 134 134
Material Integrity Problem 109 109
Insufficient Information 96 96
Migration or Expulsion of Device 88 88
Material Deformation 82 83
Mechanical Jam 64 64
Collapse 62 62
Appropriate Term/Code Not Available 57 57
Detachment of Device or Device Component 57 57
Mechanics Altered 56 56
Patient Device Interaction Problem 49 49
Material Twisted/Bent 42 42
Use of Device Problem 41 41
Device Dislodged or Dislocated 36 36
Material Fragmentation 35 35
No Apparent Adverse Event 26 26
Malposition of Device 25 25
Physical Resistance/Sticking 23 23
Crack 22 22
Improper or Incorrect Procedure or Method 21 21
Loosening of Implant Not Related to Bone-Ingrowth 20 20
Difficult to Insert 18 19
Device Handling Problem 15 15
Unintended Movement 14 14
Entrapment of Device 12 12
Device Sensing Problem 11 11
Positioning Problem 11 11
Device Slipped 11 11
Material Separation 10 10
Expulsion 8 8
Difficult to Advance 8 8
Device Damaged by Another Device 7 7
Inadequacy of Device Shape and/or Size 7 7
Inaccurate Information 6 6
Difficult or Delayed Positioning 6 6
Difficult to Remove 6 6
Incorrect, Inadequate or Imprecise Result or Readings 6 6
Imprecision 6 6
Failure to Eject 6 6
Osseointegration Problem 6 6
Material Split, Cut or Torn 5 5
Product Quality Problem 5 5
Manufacturing, Packaging or Shipping Problem 5 5
Loose or Intermittent Connection 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1439 1444
No Known Impact Or Consequence To Patient 430 430
Pain 341 341
Insufficient Information 245 245
No Consequences Or Impact To Patient 230 230
No Code Available 210 210
Failure of Implant 132 132
Unspecified Infection 106 106
Device Embedded In Tissue or Plaque 84 84
Foreign Body In Patient 82 82
Nerve Damage 73 73
Non-union Bone Fracture 66 66
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 65 65
Unspecified Tissue Injury 61 61
Hematoma 55 55
Osteolysis 54 54
Injury 47 47
Post Operative Wound Infection 42 42
Joint Laxity 36 36
Bone Fracture(s) 35 35
No Patient Involvement 30 30
Neuropathy 26 26
No Information 24 24
Cerebrospinal Fluid Leakage 23 23
Hemorrhage/Bleeding 22 22
Spinal Cord Injury 20 20
Laceration(s) 19 19
Perforation of Vessels 19 19
Unspecified Nervous System Problem 19 19
Numbness 18 18
Vertebral Fracture 16 16
Tissue Damage 15 15
Stenosis 15 15
Unspecified Musculoskeletal problem 14 14
Weakness 13 13
Patient Problem/Medical Problem 12 12
Wound Dehiscence 12 12
Fall 11 11
Arthritis 11 11
Dysphagia/ Odynophagia 11 11
Hypersensitivity/Allergic reaction 11 11
Impaired Healing 10 10
Spinal Column Injury 10 10
Inadequate Osseointegration 9 9
Discomfort 9 9
Paralysis 9 9
Headache 8 8
Cyst(s) 8 8
Neck Pain 8 8
Intervertebral Disc Compression or Protrusion 8 8

Recalls
Manufacturer Recall Class Date Posted
1 Advanced Research Medical, LLC II Apr-29-2024
2 CTL Medical Corporation II Jul-04-2020
3 CoreLink LLC II Jan-12-2023
4 DePuy Spine, Inc. II Jul-01-2022
5 DePuy Spine, Inc. II Apr-27-2019
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 SPINEART SA III Nov-22-2019
13 Stryker Spine II Apr-20-2021
14 XTANT MEDICAL INC II Jan-30-2019
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