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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device 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
ALPHATEC SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 7
ALTUS PARTNERS, LLC
  SUBSTANTIALLY EQUIVALENT 3
ALTUS SPINE
  SUBSTANTIALLY EQUIVALENT 1
ARTFX MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
ASTURA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
AUXEIN MEDICAL PRIVATE LIMITED/71164
  SUBSTANTIALLY EQUIVALENT 1
BACK 2 BASICS DIRECT, LLC
  SUBSTANTIALLY EQUIVALENT 1
BAUI BIOTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
BEIJING KEYI MEDICAL DEVICE TECHNOLOGY 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 8
CARBOFIX ORTHOPEDICS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
CG BIO CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CHANGZHOU GEASURE MEDICAL APPARATUS AND INSTRUMENTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
CLARIANCE
  SUBSTANTIALLY EQUIVALENT 2
COLIGNE AG
  SUBSTANTIALLY EQUIVALENT 1
CORELINK, LLC
  SUBSTANTIALLY EQUIVALENT 2
CORENTEC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CURITEVA, INC.
  SUBSTANTIALLY EQUIVALENT 1
DIO MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
EMINENT SPINE
  SUBSTANTIALLY EQUIVALENT 1
EVOLUTION SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 1
G SURGICAL LLC
  SUBSTANTIALLY EQUIVALENT 3
GBS COMMONWEALTH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GETSET SURGICAL, SA
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
GLOBUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
GM DOS REIS INDUSTRIA E COMERICO LTDA
  SUBSTANTIALLY EQUIVALENT 1
GRAFTON MEDICAL ALLIANCE
  SUBSTANTIALLY EQUIVALENT 1
GS MEDICAL CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
ICOTEC AG
  SUBSTANTIALLY EQUIVALENT 3
IMPLANET
  SUBSTANTIALLY EQUIVALENT 1
IMPLANET, S.A.
  SUBSTANTIALLY EQUIVALENT 1
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
INTEGRITY IMPLANTS, INC
  SUBSTANTIALLY EQUIVALENT 1
INTELIVATION LLC
  SUBSTANTIALLY EQUIVALENT 1
JMT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
JMT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JOIMAX GMBH
  SUBSTANTIALLY EQUIVALENT 1
K&J CONSULTING CORP.
  SUBSTANTIALLY EQUIVALENT 1
K2M INC.
  SUBSTANTIALLY EQUIVALENT 1
KALITEC MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
L&K BIOMED CO., LTD.
  SUBSTANTIALLY EQUIVALENT 8
LIFE SPINE INC.
  SUBSTANTIALLY EQUIVALENT 3
LIFE SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 5
MEDACTA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 3
MEDICREA INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 1
MEDICREA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 1
MEDICREA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 1
MEDOS INTERNATIONAL SARL
  SUBSTANTIALLY EQUIVALENT 4
MEDOS INTERNATIONAL SÀRL
  SUBSTANTIALLY EQUIVALENT 1
MEDOS-INTERNATIONAL, SARL
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC
  SUBSTANTIALLY EQUIVALENT 4
MEDTRONIC SOFAMOR DANEK USA, INC.
  SUBSTANTIALLY EQUIVALENT 7
MEDYNUS INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDYSSEY USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
MIKRON MAKINA SANAYI VE TICARET LTD. STI.
  SUBSTANTIALLY EQUIVALENT 1
MIRUS, LLC
  SUBSTANTIALLY EQUIVALENT 4
NANOVIS LLC
  SUBSTANTIALLY EQUIVALENT 1
NANOVIS SPINE LLC
  SUBSTANTIALLY EQUIVALENT 1
NEXT ORTHOSURGICAL
  SUBSTANTIALLY EQUIVALENT 1
NEXUS SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 2
NEXXT SPINE LLC
  SUBSTANTIALLY EQUIVALENT 2
NUVASIVE, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 3
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 1
ORTHOPEDIATRICS, CORP
  SUBSTANTIALLY EQUIVALENT 1
OSSEUS FUSION SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
OSTEOCENTRIC TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
OSTEOMED INDÚSTRIA E COMÉRCIO DE IMPLANTES LTDA
  SUBSTANTIALLY EQUIVALENT 1
PANTHEON SPINAL
  SUBSTANTIALLY EQUIVALENT 1
PIONEER SURGICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
PIONEER SURGICAL TECHNOLOGY, INC. (DBA RTI SURGICAL, INC.)
  SUBSTANTIALLY EQUIVALENT 1
PRECISION SPINE
  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 1
S.M.A.I.O
  SUBSTANTIALLY EQUIVALENT 2
S.M.A.I.O.
  SUBSTANTIALLY EQUIVALENT 1
SAFE ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
SAGICO VA USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
SEASPINE ORTHOPEDICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 7
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 ELEMENTS, INC
  SUBSTANTIALLY EQUIVALENT 1
SPINAL ELEMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
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
SPINEWAY SA
  SUBSTANTIALLY EQUIVALENT 1
SPINEWELDING AG
  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 2
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 2
ZAVATION MEDICAL PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 3
ZIMMER BIOMET SPINE, INC
  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
2019 1915 1915
2020 2076 2076
2021 1735 1737
2022 1340 1340
2023 920 920
2024 1289 1289

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1814 1814
Break 1350 1350
Migration 1156 1157
Fracture 1027 1027
Material Deformation 695 695
Loosening of Implant Not Related to Bone-Ingrowth 441 441
Device Slipped 399 399
Material Twisted/Bent 376 376
Detachment of Device or Device Component 363 363
Device-Device Incompatibility 243 243
Device Dislodged or Dislocated 234 235
Insufficient Information 211 211
Loose or Intermittent Connection 209 209
Mechanical Problem 152 152
Unintended Movement 140 140
Migration or Expulsion of Device 128 128
Appropriate Term/Code Not Available 112 112
Material Separation 111 111
Material Fragmentation 99 99
Material Integrity Problem 74 74
Material Split, Cut or Torn 72 72
Malposition of Device 70 70
No Apparent Adverse Event 62 62
Patient Device Interaction Problem 60 60
Improper or Incorrect Procedure or Method 60 60
Use of Device Problem 52 52
Biocompatibility 47 47
Compatibility Problem 46 46
Entrapment of Device 45 45
Mechanical Jam 43 43
Mechanics Altered 38 38
Crack 38 38
Separation Problem 29 29
Premature Separation 25 25
Patient-Device Incompatibility 25 25
Difficult to Remove 23 23
Failure to Align 18 18
Noise, Audible 18 18
Inaccurate Information 17 17
Failure to Osseointegrate 17 17
Separation Failure 16 16
Disconnection 15 15
Corroded 14 14
Physical Resistance/Sticking 13 13
Expulsion 12 12
Osseointegration Problem 11 11
Positioning Problem 10 10
Naturally Worn 9 9
Device Damaged by Another Device 9 9
Inadequacy of Device Shape and/or Size 9 9

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2500 2502
No Code Available 1140 1140
Pain 1095 1095
No Known Impact Or Consequence To Patient 858 858
Failure of Implant 802 803
Insufficient Information 668 668
Unspecified Infection 538 538
No Consequences Or Impact To Patient 510 510
Injury 465 465
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 334 334
Osteolysis 201 201
Non-union Bone Fracture 186 186
Nerve Damage 163 163
Foreign Body In Patient 140 140
Bone Fracture(s) 120 120
Spinal Cord Injury 118 118
Hypersensitivity/Allergic reaction 91 91
Post Operative Wound Infection 87 87
No Information 84 84
Joint Laxity 84 84
Device Embedded In Tissue or Plaque 71 71
Deformity/ Disfigurement 69 69
Unspecified Tissue Injury 65 65
Necrosis 59 59
Patient Problem/Medical Problem 50 50
Inadequate Osseointegration 48 48
Numbness 47 47
Hematoma 47 47
Vertebral Fracture 46 46
No Patient Involvement 45 45
Paralysis 44 44
Neurological Deficit/Dysfunction 42 42
Spinal Column Injury 39 39
Unspecified Nervous System Problem 37 37
Impaired Healing 37 37
Discomfort 32 32
Swelling/ Edema 28 28
Ambulation Difficulties 28 28
Limited Mobility Of The Implanted Joint 26 26
Stenosis 26 26
Tissue Damage 26 26
Death 25 25
Fall 24 24
Cerebrospinal Fluid Leakage 24 24
Pressure Sores 23 23
Inflammation 23 23
Not Applicable 21 21
Physical Asymmetry 21 21
Intervertebral Disc Compression or Protrusion 20 20
Itching Sensation 19 19

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 CTL Medical Corporation II Mar-20-2019
4 Clariance Inc III Jul-18-2019
5 Howmedica Osteonics Corp. II Aug-05-2019
6 Icotec Ag II Dec-19-2022
7 Integrity Implants Inc. II Dec-05-2022
8 Integrity Implants Inc. II Dec-05-2022
9 Medicrea International II Mar-02-2020
10 Medicrea International II Dec-30-2019
11 OrthoPediatrics Corp II Jul-30-2020
12 SAFE ORTHOPAEDICS LLC II Aug-24-2022
13 SEASPINE ORTHOPEDICS CORPORATION II Apr-23-2024
14 SEASPINE ORTHOPEDICS CORPORATION II Apr-22-2024
15 SPINEART SA II May-03-2024
16 SPINEART SA II Jun-28-2021
17 U&I CORP. II Jul-20-2020
18 XTANT Medical Holdings, Inc II Jan-29-2024
19 Zimmer Biomet Spine Inc. II Jan-04-2024
20 Zimmer Biomet Spine Inc. II Feb-22-2019
21 Zimmer Biomet, Inc. II Dec-15-2020
22 Zimmer Biomet, Inc. II Jun-02-2020
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