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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 6
ALTUS PARTNERS, LLC
  SUBSTANTIALLY EQUIVALENT 3
ALTUS SPINE
  SUBSTANTIALLY EQUIVALENT 1
ARTFX MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
ASTURA MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
AUXEIN MEDICAL PRIVATE LIMITED/71164
  SUBSTANTIALLY EQUIVALENT 1
BACK 2 BASICS DIRECT, LLC
  SUBSTANTIALLY EQUIVALENT 1
BAUI BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BEIJING FULE SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BENVENUE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIEDERMANN MOTECH GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 1
BK MEDITECH, CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BLACK BOX MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
CALVARY SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
CAPTIVA SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARBOFIX ORTHOPEDICS, LTD.
  SUBSTANTIALLY EQUIVALENT 10
CGBIO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
CHANGZHOU GEASURE MEDICAL APPARATUS AND INSTRUMENTS 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
CORENTEC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
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 1
GREENS SURGICALS PVT. , LTD.
  SUBSTANTIALLY EQUIVALENT 1
GS MEDICAL CO. , LTD.
  SUBSTANTIALLY EQUIVALENT 1
HC BIOLOGICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
HT MEDICAL D.B.A. XENIX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ICOTEC AG
  SUBSTANTIALLY EQUIVALENT 3
IMPLANET
  SUBSTANTIALLY EQUIVALENT 2
INDIUS MEDICAL TECHNOLOGIES PVT. , LTD.
  SUBSTANTIALLY EQUIVALENT 1
INGENIUM SPINE
  SUBSTANTIALLY EQUIVALENT 1
INNOSYS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
INNOVASIS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INNOVATIVE SURGICAL DESIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 4
INTEGRITY IMPLANTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
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
L & K BIOMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 7
LIFE SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 6
LOCK-IN USA CORP
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 4
MEDICREA INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 1
MEDICREA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL SARL
  SUBSTANTIALLY EQUIVALENT 6
MEDOS INTERNATIONAL SÀRL
  SUBSTANTIALLY EQUIVALENT 1
MEDOS-INTERNATIONAL SARL
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC
  SUBSTANTIALLY EQUIVALENT 4
MEDTRONIC SOFAMOR DANEK USA, INC.
  SUBSTANTIALLY EQUIVALENT 9
MEDYNUS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDYSSEY USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
MIKRON MAKINA SANAYI VE TICARET LTD. STI.
  SUBSTANTIALLY EQUIVALENT 1
NANOVIS SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
NANOVIS, LLC
  SUBSTANTIALLY EQUIVALENT 1
NEO MEDICAL SA
  SUBSTANTIALLY EQUIVALENT 1
NEXT ORTHOSURGICAL
  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
ORION BIOTECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHO DEVELOPMENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ORTHOCIRCLE SPINE
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEASIA CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIATRICS CORP.
  SUBSTANTIALLY EQUIVALENT 2
OSTEOCENTRIC TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
OSTEOMED INDÚSTRIA E COMÉRCIO DE IMPLANTES LTDA
  SUBSTANTIALLY EQUIVALENT 1
PANTHEON SPINAL
  SUBSTANTIALLY EQUIVALENT 1
PIONEER SURGICAL TECHNOLOGY, INC. (DBA RTI SURGICAL, INC.)
  SUBSTANTIALLY EQUIVALENT 1
PRECISION SPINE
  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 5
SAFE ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
SAGICO VA USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
SEASPINE ORTHOPEDICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
SEOHANCARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANGDONG KANGSHENG MEDICAL DEVICES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI REACH MEDICAL INSTRUMENT CO, LTD.
  SUBSTANTIALLY EQUIVALENT 2
SHANGHAI SANYOU MEDICAL CO, LTD.
  SUBSTANTIALLY EQUIVALENT 3
SILONY MEDICAL GMBH
  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 1
SPINE SMITH HOLDINGS, LLC
  SUBSTANTIALLY EQUIVALENT 1
SPINE WAVE, INC.
  SUBSTANTIALLY EQUIVALENT 4
SPINEART
  SUBSTANTIALLY EQUIVALENT 4
SPINEART SA
  SUBSTANTIALLY EQUIVALENT 1
SPINECRAFT, LLC
  SUBSTANTIALLY EQUIVALENT 2
SPINEWAY
  SUBSTANTIALLY EQUIVALENT 1
STRYKER INSTRUMENTS
  SUBSTANTIALLY EQUIVALENT 2
STRYKER SPINE
  SUBSTANTIALLY EQUIVALENT 2
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
WILTROM CORPORATION LIMITED
  SUBSTANTIALLY EQUIVALENT 1
XTANT MEDICAL HOLDINGS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZAVATION MEDICAL PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 4
ZIMMER BIOMET SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 2
ZIMVIE SPINE (ZIMMER BIOMET SPINE, INC.)
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2020 2076 2088
2021 1741 1748
2022 1339 1348
2023 919 939
2024 1613 1616
2025 1076 1076

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1626 1645
Break 1188 1204
Migration 1122 1129
Fracture 1025 1031
Material Deformation 662 662
Loosening of Implant Not Related to Bone-Ingrowth 545 546
Material Twisted/Bent 443 444
Device Slipped 346 346
Detachment of Device or Device Component 318 318
Device Dislodged or Dislocated 289 291
Device-Device Incompatibility 256 257
Insufficient Information 212 212
Mechanical Problem 159 160
Material Separation 109 109
Material Fragmentation 87 87
Malposition of Device 80 80
Migration or Expulsion of Device 73 73
Material Integrity Problem 71 72
Use of Device Problem 65 66
Appropriate Term/Code Not Available 64 65
Unintended Movement 63 63
Mechanics Altered 62 62
No Apparent Adverse Event 61 61
Improper or Incorrect Procedure or Method 60 60
Compatibility Problem 59 59
Entrapment of Device 47 49
Loose or Intermittent Connection 47 47
Patient Device Interaction Problem 44 45
Mechanical Jam 42 42
Crack 33 33
Biocompatibility 29 29
Separation Problem 27 27
Premature Separation 26 26
Noise, Audible 24 25
Failure to Osseointegrate 19 19
Inaccurate Information 18 18
Separation Failure 18 18
Physical Resistance/Sticking 14 14
Corroded 14 14
Patient-Device Incompatibility 12 12
Expulsion 12 12
Difficult to Remove 11 11
Device Damaged by Another Device 11 11
Wrong Label 10 10
Osseointegration Problem 10 10
Difficult to Advance 9 9
Inadequacy of Device Shape and/or Size 9 9
Product Quality Problem 9 9
Contamination /Decontamination Problem 9 9
Activation, Positioning or Separation Problem 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3209 3220
Pain 1027 1031
Insufficient Information 863 865
Failure of Implant 729 735
Unspecified Infection 534 537
No Code Available 503 503
No Known Impact Or Consequence To Patient 366 366
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 354 355
No Consequences Or Impact To Patient 341 341
Injury 273 273
Osteolysis 214 219
Non-union Bone Fracture 171 176
Foreign Body In Patient 143 148
Bone Fracture(s) 119 120
Nerve Damage 114 116
Spinal Cord Injury 88 88
Post Operative Wound Infection 87 88
Joint Laxity 84 84
Hypersensitivity/Allergic reaction 82 82
Inadequate Osseointegration 76 76
Unspecified Tissue Injury 70 73
Deformity/ Disfigurement 69 72
Numbness 66 66
Device Embedded In Tissue or Plaque 64 64
Necrosis 60 60
Unspecified Nervous System Problem 54 67
Swelling/ Edema 51 51
Vertebral Fracture 48 49
Hematoma 46 49
Spinal Column Injury 39 39
Paralysis 38 48
Patient Problem/Medical Problem 37 37
Impaired Healing 36 36
Stenosis 33 33
Ambulation Difficulties 32 34
Neurological Deficit/Dysfunction 31 41
Discomfort 28 28
Intervertebral Disc Compression or Protrusion 27 27
No Information 26 26
Cerebrospinal Fluid Leakage 26 29
Pressure Sores 24 24
Implant Pain 24 24
Hemorrhage/Bleeding 23 23
No Patient Involvement 23 23
Inflammation 23 23
Death 22 22
Physical Asymmetry 21 21
Muscle Weakness 20 21
Fall 20 20
Paresthesia 18 18

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 Medicrea International II Mar-02-2020
7 OrthoPediatrics Corp II Jul-30-2020
8 Orthofix U.S. LLC II Nov-07-2025
9 SAFE ORTHOPAEDICS LLC II Aug-24-2022
10 SEASPINE ORTHOPEDICS CORPORATION II Dec-23-2024
11 SEASPINE ORTHOPEDICS CORPORATION II Apr-23-2024
12 SEASPINE ORTHOPEDICS CORPORATION II Apr-22-2024
13 SPINEART SA II Aug-08-2025
14 SPINEART SA II May-03-2024
15 SPINEART SA II Jun-28-2021
16 U&I CORP. II Jul-20-2020
17 XTANT Medical Holdings, Inc II Oct-17-2024
18 XTANT Medical Holdings, Inc II Jan-29-2024
19 Zimmer Biomet Spine Inc. II Jan-04-2024
20 Zimmer Biomet, Inc. II Dec-15-2020
21 Zimmer Biomet, Inc. II Jun-02-2020
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