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 integrated fixation, lumbar
Regulation Description Intervertebral body fusion device.
Definition Intended to stabilize lumbar spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.
Product CodeOVD
Regulation Number 888.3080
Device Class 2


Premarket Reviews
ManufacturerDecision
4WEB MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
4WEB, INC.
  SUBSTANTIALLY EQUIVALENT 1
ACUITY SURGICAL DEVICES, LLC
  SUBSTANTIALLY EQUIVALENT 3
ALPHATEC SPINE
  SUBSTANTIALLY EQUIVALENT 1
ALPHATEC SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 2
ALTUS PARTNERS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ASTURA MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
ASTURA MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
ATLAS SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
AURORA SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
AVALIGN TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
AXIS SPINE TECHNOLOGIES, LTD.
  SUBSTANTIALLY EQUIVALENT 2
CAMBER SPINE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
CARLSMED, INC.
  SUBSTANTIALLY EQUIVALENT 4
CLARIANCE, SAS
  SUBSTANTIALLY EQUIVALENT 1
CURITEVA, INC.
  SUBSTANTIALLY EQUIVALENT 1
DEGEN MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
EMINENT SPINE
  SUBSTANTIALLY EQUIVALENT 1
EVOLUTION SPINE
  SUBSTANTIALLY EQUIVALENT 3
FOUNDATION SURGICAL GROUP, INC.
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
HD LIFESCIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 1
INNOVASIS
  SUBSTANTIALLY EQUIVALENT 1
INNOVASIS, INC.
  SUBSTANTIALLY EQUIVALENT 1
KYOCERA MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
LIFE SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC SOFAMOR DANEK USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
MIRUS, LLC
  SUBSTANTIALLY EQUIVALENT 2
NEUROSTRUCTURES
  SUBSTANTIALLY EQUIVALENT 1
NEXUS SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 4
NEXXT SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
NOVAPPROACH SPINE
  SUBSTANTIALLY EQUIVALENT 1
NOVAPPROACH SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
NU VASIVE, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 4
OMNIA MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 2
OSSEUS FUSION SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
PRECISION SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
PRO SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
SOUTHERN MEDICAL (PTY) , LTD.
  SUBSTANTIALLY EQUIVALENT 1
SPINEART
  SUBSTANTIALLY EQUIVALENT 1
SPINEART SA
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
TITAN SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZAVATION MEDICAL PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 203 203
2021 221 221
2022 74 75
2023 67 71
2024 92 92
2025 48 48

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 313 313
Migration 94 96
Break 57 57
Fracture 39 39
Patient Device Interaction Problem 36 36
Appropriate Term/Code Not Available 26 26
Material Separation 24 24
Detachment of Device or Device Component 21 21
Compatibility Problem 17 19
Device Dislodged or Dislocated 15 15
Device-Device Incompatibility 12 12
Mechanical Problem 11 11
Insufficient Information 11 11
Material Integrity Problem 9 9
Use of Device Problem 9 9
Material Fragmentation 9 9
No Apparent Adverse Event 7 7
Migration or Expulsion of Device 7 7
Loss of Osseointegration 7 7
Malposition of Device 6 6
Material Deformation 5 5
Positioning Problem 5 5
Activation, Positioning or Separation Problem 4 4
Biocompatibility 4 4
Crack 4 4
Osseointegration Problem 4 4
Device Damaged by Another Device 3 3
Failure to Osseointegrate 3 3
Material Twisted/Bent 3 4
Difficult to Insert 3 3
Difficult to Remove 3 3
Contamination 3 3
Manufacturing, Packaging or Shipping Problem 3 3
Unintended Movement 3 3
Off-Label Use 3 3
Unstable 3 3
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Misassembled 2 2
Mechanical Jam 2 2
Patient-Device Incompatibility 2 2
Product Quality Problem 2 2
Collapse 2 2
Entrapment of Device 2 2
Naturally Worn 1 1
Human-Device Interface Problem 1 1
Loose or Intermittent Connection 1 1
Inadequate User Interface 1 1
Installation-Related Problem 1 1
Device Handling Problem 1 1
Difficult or Delayed Positioning 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 164 167
Pain 123 123
No Code Available 85 85
Non-union Bone Fracture 76 76
Insufficient Information 61 63
Failure of Implant 42 42
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 40 40
Nerve Damage 37 37
Unspecified Tissue Injury 30 30
Post Operative Wound Infection 29 29
Unspecified Infection 27 27
Hematoma 26 26
Osteolysis 26 26
Dysphagia/ Odynophagia 21 21
Injury 19 19
Impaired Healing 16 16
Bone Fracture(s) 15 15
Perforation of Vessels 11 11
Cerebrospinal Fluid Leakage 10 10
Stenosis 8 8
Paresis 8 8
Foreign Body In Patient 8 8
Hypoesthesia 7 7
Abdominal Pain 7 7
Physical Asymmetry 7 7
No Known Impact Or Consequence To Patient 7 7
Device Embedded In Tissue or Plaque 6 6
No Consequences Or Impact To Patient 6 6
Spinal Column Injury 6 6
Hypersensitivity/Allergic reaction 5 5
Inadequate Osseointegration 5 5
Fatigue 5 5
Malunion of Bone 5 5
Ossification 5 5
Unspecified Nervous System Problem 5 5
Joint Laxity 4 4
Hernia 4 4
Thrombosis 4 4
Paralysis 4 4
Thrombosis/Thrombus 4 4
Blood Loss 4 4
Cyst(s) 4 4
Excessive Tear Production 3 3
Vertebral Fracture 3 3
Seroma 3 3
Spinal Cord Injury 3 3
Implant Pain 3 3
Inflammation 3 3
Bacterial Infection 3 3
Neuropathy 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Acuity Surgical Devices, LLC II Jun-11-2020
2 Alphatec Spine, Inc. II Feb-23-2024
3 Medacta Usa Inc II Apr-19-2023
4 Medicrea International II Aug-24-2023
5 Medtronic Sofamor Danek USA Inc II Jul-10-2023
6 Medtronic Sofamor Danek USA Inc II Oct-12-2021
7 Novapproach Spine LLC II Nov-17-2022
8 Omnia Medical II Sep-11-2025
9 Orthofix U.S. LLC III Dec-11-2025
10 SPINEART SA II Apr-24-2023
11 Stryker Spine II Mar-31-2025
12 XTANT Medical Holdings, Inc II Feb-19-2025
-
-