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TPLC - Total Product Life Cycle
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Device thoracolumbosacral pedicle screw system
Regulation Description Thoracolumbosacral pedicle screw system.
Definition Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.
Product CodeNKB
Regulation Number 888.3070
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP IMPLANT SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ALLUMIN8, INC.
  SUBSTANTIALLY EQUIVALENT 1
ALPHATEC SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 4
ALTUS PARTNERS, LLC
  SUBSTANTIALLY EQUIVALENT 2
ALTUS SPINE
  SUBSTANTIALLY EQUIVALENT 1
ARTFX MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
ASTURA MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
AUXEIN MEDICAL PRIVATE LIMITED/71164
  SUBSTANTIALLY EQUIVALENT 1
BAUI BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BEIJING FULE SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIEDERMANN MOTECH GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
BOX SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
CARBOFIX ORTHOPEDICS , LTD.
  SUBSTANTIALLY EQUIVALENT 7
CG BIO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
CHANGZHOU GEASURE MEDICAL APPARATUS AND INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CHANPIN MEDTAK CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CLARIANCE
  SUBSTANTIALLY EQUIVALENT 2
CMF MEDICON SURGICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
COLIGNE AG
  SUBSTANTIALLY EQUIVALENT 1
CORELINK, LLC
  SUBSTANTIALLY EQUIVALENT 2
DIO MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
DOUBLE MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
EFFORTMED, LLC
  SUBSTANTIALLY EQUIVALENT 1
EMINENT SPINE
  SUBSTANTIALLY EQUIVALENT 2
G SURGICAL, LLC
  SUBSTANTIALLY EQUIVALENT 2
GETSET SURGICAL, SA
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
GREENS SURGICALS PVT. , LTD.
  SUBSTANTIALLY EQUIVALENT 1
GS MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HC BIOLOGICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
HIGHRIDGE MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
HT MEDICAL D.B.A. XENIX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ICOTEC AG
  SUBSTANTIALLY EQUIVALENT 2
IMPLANET
  SUBSTANTIALLY EQUIVALENT 2
INGENIUM SPINE
  SUBSTANTIALLY EQUIVALENT 1
INNOSYS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
INNOVASIS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INNOVATIVE SURGICAL DESIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 3
INTEGRITY IMPLANTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTELIVATION, LLC
  SUBSTANTIALLY EQUIVALENT 1
JEIL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
JMT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
K&J CONSULTING CORP.
  SUBSTANTIALLY EQUIVALENT 1
K2M, INC.
  SUBSTANTIALLY EQUIVALENT 1
KALITEC MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
KYOCERA MEDICAL TECHNOLOGIES INC. (KMTI)
  SUBSTANTIALLY EQUIVALENT 1
L&K BIOMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
LIFE SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 5
LOCK-IN USA CORP
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 4
MEDICREA INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 1
MEDICREA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL SARL
  SUBSTANTIALLY EQUIVALENT 6
MEDOS-INTERNATIONAL SARL
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC
  SUBSTANTIALLY EQUIVALENT 3
MEDTRONIC SOFAMOR DANEK USA, INC.
  SUBSTANTIALLY EQUIVALENT 8
MEDYNUS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDYSSEY USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
MIKRON MAKINA SANAYI VE TICARET LTD. STI.
  SUBSTANTIALLY EQUIVALENT 1
NEO MEDICAL SA
  SUBSTANTIALLY EQUIVALENT 1
NEXUS SPINE
  SUBSTANTIALLY EQUIVALENT 1
NEXUS SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 2
NEXXT SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 2
NU VASIVE, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
ORTHO DEVELOPMENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEASIA CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIATRICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
OSTEOCENTRIC TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
OSTEOMED INDÚSTRIA E COMÉRCIO DE IMPLANTES LTDA
  SUBSTANTIALLY EQUIVALENT 1
OSTEOMNI, INC.
  SUBSTANTIALLY EQUIVALENT 1
PANTHEON SPINAL
  SUBSTANTIALLY EQUIVALENT 1
PRECISION SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
PREMIA SPINE, LTD.
  SUBSTANTIALLY EQUIVALENT 2
RELIANCE MEDICAL SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
REPUBLIC SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 2
RIVARP MEDICAL PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
S.H.PITKAR ORTHOTOOLS PVT. , LTD.
  SUBSTANTIALLY EQUIVALENT 1
S.M.A.I.O
  SUBSTANTIALLY EQUIVALENT 8
SAGICO VA USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
SEASPINE ORTHOPEDICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
SHANGHAI REACH MEDICAL INSTRUMENT CO, LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHANGHAI SANYOU MEDICAL CO, LTD.
  SUBSTANTIALLY EQUIVALENT 3
SILONY MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 1
SOCKO MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SOLCO BIOMEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SOLCO BIOMEDICAL COPANY INDIA PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
SPINAL ALIGNMENT SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINAL ELEMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
SPINAL RESOURCES, INC.
  SUBSTANTIALLY EQUIVALENT 2
SPINE WAVE, INC.
  SUBSTANTIALLY EQUIVALENT 3
SPINEART
  SUBSTANTIALLY EQUIVALENT 2
SPINEART SA
  SUBSTANTIALLY EQUIVALENT 2
SPINECRAFT, LLC
  SUBSTANTIALLY EQUIVALENT 2
SPINEWAY
  SUBSTANTIALLY EQUIVALENT 1
STRYKER INSTRUMENTS
  SUBSTANTIALLY EQUIVALENT 2
STRYKER SPINE
  SUBSTANTIALLY EQUIVALENT 1
SURGALIGN SPINE TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
TAEYEON MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TDM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TESLAKE, INC.
  SUBSTANTIALLY EQUIVALENT 1
ULRICH MEDICAL USA
  SUBSTANTIALLY EQUIVALENT 1
ULRICH MEDICAL USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
VY SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 2
XTANT MEDICAL HOLDINGS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZAVATION MEDICAL PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 4
ZHEJIANG DECANS MEDICAL DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER BIOMET SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 2
ZIMVIE SPINE (ZIMMER BIOMET SPINE, INC.)
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2021 1745 1752
2022 1339 1348
2023 919 939
2024 1608 1611
2025 1189 1189
2026 677 677

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1378 1387
Break 982 994
Migration 940 947
Fracture 807 813
Material Deformation 528 528
Loosening of Implant Not Related to Bone-Ingrowth 461 462
Material Twisted/Bent 394 395
Device Dislodged or Dislocated 312 313
Device Slipped 285 285
Detachment of Device or Device Component 241 241
Insufficient Device Problem Information 226 226
Device-Device Incompatibility 177 178
Mechanical Problem 151 152
Material Separation 83 83
Material Fragmentation 77 77
Malposition of Device 76 76
Mechanics Altered 75 75
Use of Device Problem 63 64
Compatibility Problem 59 59
Improper or Incorrect Procedure or Method 56 56
Material Integrity Problem 51 52
Entrapment of Device 47 49
Patient Device Interaction Problem 45 46
Appropriate Device Problem Term/Code Not Available 42 43
No Apparent Adverse Event 40 40
Migration or Expulsion of Device 35 35
Biocompatibility 26 26
Premature Separation 26 26
Separation Problem 25 25
Mechanical Jam 22 22
Inaccurate Information 18 18
Unintended Movement 18 18
Separation Failure 17 17
Failure to Osseointegrate 17 17
Leak/Splash 15 15
Loose or Intermittent Connection 15 15
Patient-Device Incompatibility 14 14
Damaged Thread 14 14
Osseointegration Problem 14 14
Noise, Audible 14 14
Difficult to Advance 12 12
Expulsion 12 12
Wrong Label 10 10
Crack 10 10
Product Quality Problem 10 10
Contamination /Decontamination Problem 9 9
Device Damaged by Another Device 9 9
Backflow 9 9
Difficult to Remove 9 9
Manufacturing, Packaging or Shipping Problem 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3382 3393
Insufficient Information 949 951
Pain 832 834
Unspecified Infection 513 516
Failure of Implant 483 489
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 355 356
Osteolysis 215 220
Nonunion/Delayed-union Bone Fracture 161 166
Bone Fracture(s) 146 147
Unspecified Tissue Injury 130 133
Foreign Body In Patient 119 124
Numbness 116 116
Nerve Damage 103 103
Impaired Healing 89 89
Joint Laxity 84 84
Spinal Cord Injury 84 84
Post Operative Wound Infection 83 84
Deformity/ Disfigurement 74 77
Inflammation 69 69
Inadequate Osseointegration 68 68
Fatigue 65 65
Loss of Range of Motion 63 63
Thrombosis/Thrombus 61 64
Device Embedded In Tissue or Plaque 59 59
Necrosis 59 59
Depression 56 56
Back pain 55 55
Vertebral Fracture 49 50
Stenosis 47 47
Hematoma 47 50
Unspecified Nervous System Problem 46 49
Spinal Column Injury 41 41
Hypersensitivity/Allergic reaction 41 41
Swelling/ Edema 36 36
Intervertebral Disc Compression or Protrusion 35 35
Ambulation or Postural Difficulties 32 32
Implant Pain 28 28
Discomfort 28 28
No Consequences Or Impact To Patient 27 27
Cerebrospinal Fluid Leakage 27 30
Muscle Weakness/Atrophy 26 27
Pressure Sore/Ulcer 26 26
Paresthesia 25 25
Hemorrhage/Blood Loss/Bleeding 23 23
Physical Asymmetry 21 21
Paralysis 16 16
Fall 15 15
Unspecified Musculoskeletal problem 14 14
Neuropathy 13 13
Cardiac Arrest 13 13

Recalls
Manufacturer Recall Class Date Posted
1 Aesculap Implant Systems LLC II Aug-26-2022
2 Aesculap Implant Systems LLC II Jul-21-2022
3 Icotec Ag II Dec-19-2022
4 Integrity Implants Inc. II Dec-05-2022
5 Integrity Implants Inc. II Dec-05-2022
6 Orthofix U.S. LLC II Nov-07-2025
7 SAFE ORTHOPAEDICS LLC II Aug-24-2022
8 SEASPINE ORTHOPEDICS CORPORATION II Dec-23-2024
9 SEASPINE ORTHOPEDICS CORPORATION II Apr-23-2024
10 SEASPINE ORTHOPEDICS CORPORATION II Apr-22-2024
11 SPINEART SA II Aug-08-2025
12 SPINEART SA II May-03-2024
13 SPINEART SA II Jun-28-2021
14 XTANT Medical Holdings, Inc II Oct-17-2024
15 XTANT Medical Holdings, Inc II Jan-29-2024
16 Zimmer Biomet Spine Inc. II Jan-04-2024
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