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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 6
ALTUS PARTNERS, LLC
  SUBSTANTIALLY EQUIVALENT 3
ALTUS SPINE
  SUBSTANTIALLY EQUIVALENT 1
ARTFX MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
ASTURA MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
AUXEIN MEDICAL PRIVATE LIMITED/71164
  SUBSTANTIALLY EQUIVALENT 1
BACK 2 BASICS DIRECT, LLC
  SUBSTANTIALLY EQUIVALENT 1
BAUI BIOTECH 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 9
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
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
EMINENT SPINE
  SUBSTANTIALLY EQUIVALENT 1
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
ICOTEC AG
  SUBSTANTIALLY EQUIVALENT 2
IMPLANET
  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
INTELIVATION LLC
  SUBSTANTIALLY EQUIVALENT 1
JEIL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
JMT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
JMT CO., LTD.
  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 7
LIFE SPINE INC.
  SUBSTANTIALLY EQUIVALENT 1
LIFE SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 5
LOCK-IN USA CORP
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL SA
  SUBSTANTIALLY EQUIVALENT 3
MEDICREA INTERNATIONAL
  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 8
MEDYNUS INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDYSSEY USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
MIKRON MAKINA SANAYI VE TICARET LTD. STI.
  SUBSTANTIALLY EQUIVALENT 1
NANOVIS LLC
  SUBSTANTIALLY EQUIVALENT 1
NANOVIS SPINE LLC
  SUBSTANTIALLY EQUIVALENT 1
NEO MEDICAL SA
  SUBSTANTIALLY EQUIVALENT 1
NEXT ORTHOSURGICAL
  SUBSTANTIALLY EQUIVALENT 1
NEXUS SPINE, LLC
  SUBSTANTIALLY EQUIVALENT 2
NEXXT SPINE LLC
  SUBSTANTIALLY EQUIVALENT 2
NUVASIVE, 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 1
ORTHOPEDIATRICS, CORP
  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. (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 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 5
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 1
SPINAL RESOURCES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SPINE SMITH HOLDINGS, LLC
  SUBSTANTIALLY EQUIVALENT 1
SPINE WAVE, INC.
  SUBSTANTIALLY EQUIVALENT 3
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
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 1
ZAVATION MEDICAL PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER BIOMET SPINE, INC
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER BIOMET SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZIMVIE SPINE (ZIMMER BIOMET SPINE, INC.)
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2020 2076 2076
2021 1735 1737
2022 1340 1340
2023 920 920
2024 1618 1618

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1532 1532
Migration 997 998
Break 988 988
Fracture 880 880
Material Deformation 597 597
Loosening of Implant Not Related to Bone-Ingrowth 429 429
Material Twisted/Bent 367 367
Device Slipped 328 328
Detachment of Device or Device Component 290 290
Device-Device Incompatibility 225 225
Device Dislodged or Dislocated 203 204
Insufficient Information 202 202
Mechanical Problem 140 140
Material Separation 104 104
Material Fragmentation 82 82
Migration or Expulsion of Device 70 70
Material Integrity Problem 67 67
Malposition of Device 64 64
No Apparent Adverse Event 59 59
Appropriate Term/Code Not Available 58 58
Unintended Movement 58 58
Improper or Incorrect Procedure or Method 55 55
Compatibility Problem 51 51
Use of Device Problem 50 50
Entrapment of Device 46 46
Mechanics Altered 45 45
Patient Device Interaction Problem 41 41
Mechanical Jam 41 41
Loose or Intermittent Connection 40 40
Crack 33 33
Biocompatibility 28 28
Separation Problem 27 27
Premature Separation 25 25
Separation Failure 18 18
Inaccurate Information 18 18
Failure to Osseointegrate 17 17
Noise, Audible 16 16
Corroded 14 14
Physical Resistance/Sticking 13 13
Expulsion 12 12
Patient-Device Incompatibility 10 10
Osseointegration Problem 10 10
Difficult to Remove 9 9
Device Damaged by Another Device 8 8
Activation, Positioning or Separation Problem 8 8
Product Quality Problem 8 8
Inadequacy of Device Shape and/or Size 8 8
Difficult to Advance 8 8
Contamination /Decontamination Problem 7 7
Difficult to Insert 7 7

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2662 2664
Pain 895 895
Insufficient Information 711 711
Failure of Implant 640 640
Unspecified Infection 508 508
No Code Available 503 503
No Known Impact Or Consequence To Patient 366 366
No Consequences Or Impact To Patient 341 341
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 336 336
Injury 273 273
Osteolysis 200 200
Non-union Bone Fracture 160 160
Foreign Body In Patient 133 133
Nerve Damage 113 113
Bone Fracture(s) 107 107
Post Operative Wound Infection 85 85
Spinal Cord Injury 84 84
Joint Laxity 84 84
Hypersensitivity/Allergic reaction 81 81
Deformity/ Disfigurement 69 69
Unspecified Tissue Injury 65 65
Necrosis 59 59
Device Embedded In Tissue or Plaque 52 52
Inadequate Osseointegration 51 51
Vertebral Fracture 48 48
Numbness 46 46
Hematoma 41 41
Paralysis 38 38
Unspecified Nervous System Problem 37 37
Patient Problem/Medical Problem 37 37
Swelling/ Edema 35 35
Impaired Healing 35 35
Neurological Deficit/Dysfunction 31 31
Ambulation Difficulties 28 28
Spinal Column Injury 28 28
No Information 26 26
Pressure Sores 23 23
No Patient Involvement 23 23
Cerebrospinal Fluid Leakage 23 23
Inflammation 23 23
Stenosis 23 23
Intervertebral Disc Compression or Protrusion 22 22
Death 22 22
Physical Asymmetry 21 21
Discomfort 21 21
Implant Pain 18 18
Hemorrhage/Bleeding 17 17
Fall 17 17
Muscle Weakness 16 16
Swelling 16 16

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 SAFE ORTHOPAEDICS LLC II Aug-24-2022
9 SEASPINE ORTHOPEDICS CORPORATION II Dec-23-2024
10 SEASPINE ORTHOPEDICS CORPORATION II Apr-23-2024
11 SEASPINE ORTHOPEDICS CORPORATION II Apr-22-2024
12 SPINEART SA II May-03-2024
13 SPINEART SA II Jun-28-2021
14 U&I CORP. II Jul-20-2020
15 XTANT Medical Holdings, Inc II Oct-17-2024
16 XTANT Medical Holdings, Inc II Jan-29-2024
17 Zimmer Biomet Spine Inc. II Jan-04-2024
18 Zimmer Biomet, Inc. II Dec-15-2020
19 Zimmer Biomet, Inc. II Jun-02-2020
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