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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device screw, fixation, bone
Regulation Description Smooth or threaded metallic bone fixation fastener.
Product CodeHWC
Regulation Number 888.3040
Device Class 2


Premarket Reviews
ManufacturerDecision
AAP IMPLANTATE AG
  SUBSTANTIALLY EQUIVALENT 1
ACUMED, LLC
  SUBSTANTIALLY EQUIVALENT 2
AJU PHARM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 5
ASTRA ORTHOMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
AUXANO MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
AUXEIN MEDICAL PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 2
AVANTI ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
AZURMEDS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BESPA GLOBAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
BRM EXTREMITIES
  SUBSTANTIALLY EQUIVALENT 1
BRM EXTREMITIES SRL
  SUBSTANTIALLY EQUIVALENT 1
CHM SP. Z O.O.
  SUBSTANTIALLY EQUIVALENT 1
CURVAFIX, INC.
  SUBSTANTIALLY EQUIVALENT 2
DEV4
  SUBSTANTIALLY EQUIVALENT 2
DOUBLE MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 3
DUNAMIS MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
EXSOMED CORP.
  SUBSTANTIALLY EQUIVALENT 1
EXTREMITY MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 2
FIELD ORTHOPAEDICS PTY, LTD.
  SUBSTANTIALLY EQUIVALENT 1
FLOWER ORTHOPEDICS CORPORATION DBA CONVENTUS FLOWER ORTHO
  SUBSTANTIALLY EQUIVALENT 1
FORMA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
FUSION ORTHOPEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
GLW, INC.
  SUBSTANTIALLY EQUIVALENT 1
GM DOS REIS INDUSTRIA E COMERCIO LTDA.
  SUBSTANTIALLY EQUIVALENT 1
IN2BONES USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
INION OY
  SUBSTANTIALLY EQUIVALENT 1
INNOVATE ORTHOPAEDICS LIMITED
  SUBSTANTIALLY EQUIVALENT 2
INNOVATE ORTHOPAEDICS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
JEIL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
MAXXION MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDACTA INTERNATIONAL S.A.
  SUBSTANTIALLY EQUIVALENT 2
MEDARTIS AG
  SUBSTANTIALLY EQUIVALENT 2
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, LP
  SUBSTANTIALLY EQUIVALENT 2
MEDSHAPE, INC.
  SUBSTANTIALLY EQUIVALENT 4
MICROWARE PRECISION CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NEXTREMITY SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 4
NOVASTEP
  SUBSTANTIALLY EQUIVALENT 1
NVISION BIOMEDICAL TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
NVISION BIOMEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
ORTHOCIRCLE SPINE D.B.A. OC MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX SRL
  SUBSTANTIALLY EQUIVALENT 1
ORTHONOVIS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPAEDIC IMPLANT COMPANY
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIC DESIGNS NORTH AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
OSSIO , LTD.
  SUBSTANTIALLY EQUIVALENT 4
OSTEOCENTRIC TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 4
PACE SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28, INC.
  SUBSTANTIALLY EQUIVALENT 3
RELJA INNOVATIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
SIGNUS MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 1
SKELETAL DYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
STABILIZ ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER GMBH
  SUBSTANTIALLY EQUIVALENT 2
TDM CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
TIGON MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
TRAX SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
TREACE MEDICAL CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 4
TRIMED, INC.
  SUBSTANTIALLY EQUIVALENT 4
TYBER MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 2
UNIVERSITY OF UTAH, DEPARTMENT OF ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 2
VILEX, LLC
  SUBSTANTIALLY EQUIVALENT 3
VOOM MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL TECHNOLOGY
  SUBSTANTIALLY EQUIVALENT 1
WRIGHTMEDICALTECHNOLOGYINC
  SUBSTANTIALLY EQUIVALENT 1
ZIMED MEDIKAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 4446 4519
2022 3934 4331
2023 3718 3738
2024 3575 3582
2025 2929 3011
2026 701 701

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 7606 7985
Break 4738 4817
Migration 1671 1736
Device-Device Incompatibility 1554 1559
Fracture 696 707
Entrapment of Device 496 497
Material Twisted/Bent 441 441
Patient Device Interaction Problem 298 298
Device Slipped 264 265
Material Deformation 228 229
Loosening of Implant Not Related to Bone-Ingrowth 208 212
Device Dislodged or Dislocated 204 216
Positioning Failure 204 204
Manufacturing, Packaging or Shipping Problem 194 194
No Apparent Adverse Event 175 175
Material Fragmentation 163 163
Insufficient Information 156 156
Difficult to Advance 135 135
Detachment of Device or Device Component 128 131
Patient-Device Incompatibility 127 130
Use of Device Problem 106 106
Material Integrity Problem 83 84
Crack 73 73
Appropriate Term/Code Not Available 69 69
Migration or Expulsion of Device 66 66
Difficult to Remove 60 60
Unintended Movement 54 54
Mechanical Jam 50 51
Off-Label Use 50 50
Defective Device 43 45
Biocompatibility 40 40
Difficult to Insert 39 39
Failure to Advance 35 35
Physical Resistance/Sticking 34 34
Device Contaminated During Manufacture or Shipping 34 34
Improper or Incorrect Procedure or Method 33 33
Mechanical Problem 32 33
Material Split, Cut or Torn 31 31
Loss of Osseointegration 28 28
Tear, Rip or Hole in Device Packaging 24 24
Material Separation 22 22
Malposition of Device 21 21
Unstable 20 20
Fitting Problem 20 20
Compatibility Problem 20 20
Packaging Problem 20 20
Inadequacy of Device Shape and/or Size 19 25
Loose or Intermittent Connection 18 18
Positioning Problem 18 18
Osseointegration Problem 17 17

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5837 5926
Non-union Bone Fracture 2755 2913
Insufficient Information 2380 2455
Pain 1891 1922
Unspecified Infection 1231 1243
Failure of Implant 1197 1240
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 975 975
Foreign Body In Patient 868 873
Bone Fracture(s) 534 548
Post Operative Wound Infection 424 426
Unspecified Tissue Injury 385 385
Malunion of Bone 337 366
Discomfort 314 319
Loss of Range of Motion 296 304
Skin Inflammation/ Irritation 296 296
Hypersensitivity/Allergic reaction 276 277
Implant Pain 273 301
Physical Asymmetry 265 265
Swelling/ Edema 219 222
Necrosis 208 264
Wound Dehiscence 162 162
Nerve Damage 159 161
Impaired Healing 151 156
Muscular Rigidity 127 132
Deformity/ Disfigurement 103 104
Inflammation 91 92
Numbness 82 83
Muscle/Tendon Damage 82 83
Foreign Body Reaction 80 82
Hematoma 80 80
Device Embedded In Tissue or Plaque 79 83
Ambulation Difficulties 75 75
Arthritis 73 78
Distress 71 71
Fall 64 64
Joint Laxity 60 60
Metal Related Pathology 57 57
Joint Dislocation 57 59
Adhesion(s) 52 57
Limb Fracture 51 68
Abscess 46 47
Ossification 43 43
Osteolysis 40 41
Rash 35 35
Thrombosis/Thrombus 34 35
Inadequate Osseointegration 32 32
Local Reaction 31 31
Hip Fracture 29 29
Scar Tissue 27 27
Hemorrhage/Bleeding 25 25

Recalls
Manufacturer Recall Class Date Posted
1 Acumed LLC II Dec-23-2022
2 Acumed LLC II Apr-20-2022
3 I.T.S. GmbH II Mar-20-2026
4 In2Bones, SAS II Mar-20-2024
5 Medartis AG II Mar-10-2026
6 Medartis Inc. II May-14-2024
7 Medshape, INC. II Jan-04-2022
8 Nextremity Solutions II Apr-12-2022
9 Nextremity Solutions II Mar-09-2022
10 Nextremity Solutions II Apr-27-2021
11 SCIENCE & BIO MATERIALS II Jul-08-2022
12 Smith & Nephew, Inc. II Dec-18-2025
13 Smith & Nephew, Inc. II Oct-19-2021
14 TriMed Inc. II May-10-2024
15 Zimmer, Inc. II Apr-30-2024
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