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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device appliance, fixation, nail/blade/plate combination, multiple component
Regulation Description Single/multiple component metallic bone fixation appliances and accessories.
Product CodeKTT
Regulation Number 888.3030
Device Class 2


Premarket Reviews
ManufacturerDecision
AIKE (SHANGHAI) MEDICAL INSTRUMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
AMDT HOLDINGS, INC
  SUBSTANTIALLY EQUIVALENT 1
ARROWHEAD DE, LLC
  SUBSTANTIALLY EQUIVALENT 2
ARTHREX INC
  SUBSTANTIALLY EQUIVALENT 1
AUSTIN MILLER TRAUMA LLC
  SUBSTANTIALLY EQUIVALENT 1
AUXEIN MEDICAL PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
DEPUY SYNTHES
  SUBSTANTIALLY EQUIVALENT 1
EXTREMITY MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 2
GLW MEDICAL INNOVATION
  SUBSTANTIALLY EQUIVALENT 1
METRIC MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEW STANDARD DEVICE DBA METALOGIX
  SUBSTANTIALLY EQUIVALENT 2
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX SRL
  SUBSTANTIALLY EQUIVALENT 1
ORTHONOVIS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPAEDIC IMPLANT COMPANY
  SUBSTANTIALLY EQUIVALENT 2
ORTHOPEDIATRICS CORP.
  SUBSTANTIALLY EQUIVALENT 3
ORTHOSPIN
  SUBSTANTIALLY EQUIVALENT 1
ORTHOSPIN LTD
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28, INC
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28, INC.
  SUBSTANTIALLY EQUIVALENT 4
RESPONSE ORTHO SOLUTIONS LLC
  SUBSTANTIALLY EQUIVALENT 1
S H PITKAR ORTHOTOOLS PVT LTD
  SUBSTANTIALLY EQUIVALENT 1
S H PITKAR ORTHOTOOLS PVT LTD.
  SUBSTANTIALLY EQUIVALENT 2
SEQUEL MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 2
STRYKER GMBH
  SUBSTANTIALLY EQUIVALENT 3
SYNTHES (USA) PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
VILEX LLC
  SUBSTANTIALLY EQUIVALENT 1
VILEX, LLC
  SUBSTANTIALLY EQUIVALENT 2
WISHBONE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2019 800 800
2020 942 942
2021 961 961
2022 627 628
2023 554 554
2024 523 523
2025 607 607

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2244 2244
Break 837 837
Device-Device Incompatibility 508 508
Migration 496 497
Fracture 201 201
Material Twisted/Bent 110 110
Mechanical Problem 79 79
Material Deformation 66 66
Device Slipped 63 63
Insufficient Information 60 60
No Apparent Adverse Event 57 57
Use of Device Problem 51 51
Migration or Expulsion of Device 48 48
Mechanical Jam 46 46
Manufacturing, Packaging or Shipping Problem 45 45
Appropriate Term/Code Not Available 44 44
Crack 42 42
Detachment of Device or Device Component 37 37
Defective Device 29 29
Loosening of Implant Not Related to Bone-Ingrowth 27 27
Entrapment of Device 23 23
Corroded 22 22
Loss of Osseointegration 16 16
Difficult to Advance 14 14
Physical Resistance/Sticking 14 14
Device Contaminated During Manufacture or Shipping 14 14
Material Integrity Problem 12 12
Unintended Movement 11 11
Mechanics Altered 11 11
Contamination /Decontamination Problem 11 11
Improper or Incorrect Procedure or Method 10 10
Connection Problem 9 9
Positioning Failure 9 9
Naturally Worn 8 8
Unintended System Motion 7 7
Material Fragmentation 7 7
Device Dislodged or Dislocated 6 6
Off-Label Use 6 6
Failure to Osseointegrate 6 6
Device Damaged Prior to Use 5 5
Patient-Device Incompatibility 5 5
Material Separation 5 5
Difficult to Remove 5 5
Failure to Cut 5 5
Degraded 5 5
Material Discolored 5 5
Device Difficult to Setup or Prepare 5 5
Loose or Intermittent Connection 5 5
Incomplete or Inadequate Connection 4 4
Difficult or Delayed Positioning 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1008 1008
No Code Available 771 771
Non-union Bone Fracture 547 547
Pain 523 523
Failure of Implant 381 381
Insufficient Information 381 382
Bone Fracture(s) 369 369
Unspecified Infection 285 285
Necrosis 269 269
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 216 216
No Consequences Or Impact To Patient 164 164
Post Operative Wound Infection 159 159
Injury 146 146
Physical Asymmetry 126 126
Malunion of Bone 96 96
No Patient Involvement 85 85
No Known Impact Or Consequence To Patient 80 80
Impaired Healing 71 71
Osteomyelitis 70 70
Fall 58 58
Loss of Range of Motion 54 54
Unspecified Tissue Injury 49 49
Foreign Body In Patient 37 37
Discomfort 37 37
Limb Fracture 34 34
Deformity/ Disfigurement 30 30
Hypersensitivity/Allergic reaction 28 28
Joint Dislocation 26 26
Nerve Damage 25 25
Swelling/ Edema 24 24
Hematoma 24 24
Implant Pain 21 21
Ambulation Difficulties 19 19
Wound Dehiscence 18 18
Arthritis 17 17
Fluid Discharge 14 14
Thrombosis/Thrombus 13 13
Sepsis 13 13
No Information 11 11
Reaction 11 11
Metal Related Pathology 10 10
Blood Loss 10 10
Foreign Body Embolism 9 9
Skin Erosion 9 9
Bacterial Infection 9 9
Inflammation 9 9
Hemorrhage/Bleeding 8 8
Device Embedded In Tissue or Plaque 8 8
Skin Inflammation/ Irritation 7 7
Fistula 7 7

Recalls
Manufacturer Recall Class Date Posted
1 Howmedica Osteonics Corp. II Feb-16-2022
2 Medicalplastic S.R.L. II Nov-17-2021
3 Medshape, INC. II Sep-03-2025
4 New Standard Device Inc II Jun-09-2023
5 New Standard Device Inc II Aug-29-2022
6 New Standard Device Inc II Jun-03-2022
7 OrthoPediatrics Corp II Sep-06-2022
8 Orthofix Srl II Nov-14-2019
9 Stryker GmbH II Jun-27-2024
10 Stryker GmbH II Mar-01-2023
11 Wishbone Medical, Inc. II Feb-07-2023
12 Zimmer Biomet, Inc. II Nov-22-2019
13 Zimmer Biomet, Inc. II Nov-07-2019
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