Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 7
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 2
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 5
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
STEPS ORTHO
  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 5
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 3717 3737
2024 3575 3582
2025 2929 3011
2026 1754 1754

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 7819 8197
Break 4626 4705
Migration 1767 1832
Device-Device Incompatibility 1661 1664
Fracture 770 781
Entrapment of Device 487 488
Material Twisted/Bent 442 442
Material Deformation 389 390
Patient Device Interaction Problem 309 309
Device Slipped 271 272
Loosening of Implant Not Related to Bone-Ingrowth 238 240
Positioning Failure 207 207
Manufacturing, Packaging or Shipping Problem 202 202
Device Dislodged or Dislocated 192 203
No Apparent Adverse Event 180 180
Material Fragmentation 173 173
Insufficient Device Problem Information 156 156
Difficult to Advance 142 142
Patient-Device Incompatibility 135 135
Detachment of Device or Device Component 125 126
Use of Device Problem 105 105
Crack 104 104
Material Integrity Problem 82 83
Migration or Expulsion of Device 65 65
Appropriate Device Problem Term/Code Not Available 64 64
Unintended Movement 57 57
Off-Label Use 51 51
Difficult to Remove 48 48
Mechanical Jam 48 49
Failure to Advance 40 40
Biocompatibility 40 40
Difficult to Insert 36 36
Device Contaminated During Manufacture or Shipping 34 34
Defective Device 34 34
Loss of Osseointegration 31 31
Material Split, Cut or Torn 29 29
Mechanical Problem 28 29
Improper or Incorrect Procedure or Method 27 27
Physical Resistance/Sticking 26 26
Tear, Rip or Hole in Device Packaging 25 25
Malposition of Device 23 23
Unstable 21 21
Damaged Thread 20 20
Fitting Problem 20 20
Material Separation 19 19
Packaging Problem 19 19
Compatibility Problem 19 19
Inadequacy of Device Shape and/or Size 18 24
Osseointegration Problem 18 18
Inaccurate Information 17 17

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6334 6423
Nonunion/Delayed-union Bone Fracture 2840 2998
Insufficient Information 2516 2591
Pain 2002 2033
Unspecified Infection 1254 1266
Failure of Implant 1210 1253
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 975 975
Foreign Body In Patient 932 937
Bone Fracture(s) 554 568
Post Operative Wound Infection 447 449
Unspecified Tissue Injury 391 391
Malunion of Bone 364 393
Skin Inflammation/ Irritation 328 328
Discomfort 320 325
Loss of Range of Motion 307 315
Hypersensitivity/Allergic reaction 286 287
Implant Pain 286 314
Physical Asymmetry 275 275
Swelling/ Edema 243 246
Necrosis 213 269
Impaired Healing 175 180
Wound Dehiscence 173 173
Nerve Damage 162 164
Muscular Rigidity 127 132
Deformity/ Disfigurement 105 106
Inflammation 94 95
Device Embedded In Tissue or Plaque 87 91
Foreign Body Reaction 85 87
Numbness 84 85
Muscle/Tendon Damage 82 83
Hematoma 80 80
Ambulation or Postural Difficulties 76 76
Arthritis 74 79
Distress 71 71
Joint Laxity 67 67
Fall 65 65
Joint Dislocation 61 63
Metal Related Pathology 60 60
Limb Fracture 52 69
Adhesion(s) 52 57
Fluid Discharge 47 47
Abscess 47 48
Extraskeletal ossification 43 43
Osteolysis 41 42
Thrombosis/Thrombus 40 41
Inadequate Osseointegration 38 38
Rash 35 35
Fatigue 34 34
Seroma 32 32
Local Reaction 31 31

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 Jun-09-2026
6 Medartis AG II Mar-10-2026
7 Medartis Inc. II May-14-2024
8 Medshape, INC. II Jan-04-2022
9 Nextremity Solutions II Apr-12-2022
10 Nextremity Solutions II Mar-09-2022
11 Nextremity Solutions II Apr-27-2021
12 SCIENCE & BIO MATERIALS II Jul-08-2022
13 Smith & Nephew, Inc. II Dec-18-2025
14 Smith & Nephew, Inc. II Oct-19-2021
15 TriMed Inc. II May-10-2024
16 Zimmer, Inc. II Apr-30-2024
-
-