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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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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
ARROWHEAD DE, LLC
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX INC
  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 1
ORTHOFIX S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX SRL
  SUBSTANTIALLY EQUIVALENT 1
ORTHONOVIS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPAEDIC IMPLANT COMPANY
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIATRICS CORP.
  SUBSTANTIALLY EQUIVALENT 3
ORTHOSPIN LTD
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28, INC
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28, INC.
  SUBSTANTIALLY EQUIVALENT 2
RESPONSE ORTHO SOLUTIONS LLC
  SUBSTANTIALLY EQUIVALENT 1
S H PITKAR ORTHOTOOLS PVT LTD
  SUBSTANTIALLY EQUIVALENT 1
S H PITKAR ORTHOTOOLS PVT LTD.
  SUBSTANTIALLY EQUIVALENT 1
SEQUEL MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 2
STRYKER GMBH
  SUBSTANTIALLY EQUIVALENT 2
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
2020 942 942
2021 961 961
2022 627 628
2023 554 554
2024 524 524
2025 429 429

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1895 1895
Break 653 653
Device-Device Incompatibility 401 401
Migration 393 394
Fracture 160 160
Material Twisted/Bent 75 75
Mechanical Problem 57 57
Material Deformation 50 50
Use of Device Problem 48 48
Insufficient Information 48 48
Manufacturing, Packaging or Shipping Problem 44 44
Mechanical Jam 43 43
Device Slipped 35 35
Appropriate Term/Code Not Available 33 33
Crack 30 30
No Apparent Adverse Event 27 27
Defective Device 24 24
Entrapment of Device 22 22
Migration or Expulsion of Device 22 22
Detachment of Device or Device Component 21 21
Corroded 19 19
Loosening of Implant Not Related to Bone-Ingrowth 19 19
Device Contaminated During Manufacture or Shipping 14 14
Physical Resistance/Sticking 14 14
Difficult to Advance 13 13
Loss of Osseointegration 13 13
Material Integrity Problem 12 12
Mechanics Altered 11 11
Connection Problem 9 9
Unintended Movement 8 8
Positioning Failure 8 8
Unintended System Motion 7 7
Naturally Worn 7 7
Failure to Osseointegrate 6 6
Improper or Incorrect Procedure or Method 6 6
Material Fragmentation 5 5
Device Difficult to Setup or Prepare 5 5
Off-Label Use 5 5
Failure to Cut 5 5
Material Separation 5 5
Patient Device Interaction Problem 4 4
Degraded 4 4
Material Discolored 4 4
Incomplete or Inadequate Connection 4 4
Device Damaged Prior to Use 4 4
Loose or Intermittent Connection 3 3
Contamination /Decontamination Problem 3 3
Component Missing 3 3
Device Markings/Labelling Problem 3 3
Difficult to Remove 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 914 914
Non-union Bone Fracture 490 490
Pain 432 432
No Code Available 397 397
Insufficient Information 358 359
Failure of Implant 337 337
Bone Fracture(s) 271 271
Necrosis 235 235
Unspecified Infection 221 221
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 214 214
Post Operative Wound Infection 159 159
Physical Asymmetry 125 125
Injury 108 108
No Consequences Or Impact To Patient 85 85
Osteomyelitis 70 70
Malunion of Bone 68 68
Loss of Range of Motion 52 52
Fall 52 52
Unspecified Tissue Injury 49 49
No Known Impact Or Consequence To Patient 43 43
No Patient Involvement 40 40
Impaired Healing 36 36
Limb Fracture 34 34
Foreign Body In Patient 32 32
Hypersensitivity/Allergic reaction 25 25
Discomfort 24 24
Swelling/ Edema 23 23
Joint Dislocation 23 23
Nerve Damage 23 23
Implant Pain 21 21
Deformity/ Disfigurement 20 20
Hematoma 20 20
Ambulation Difficulties 19 19
Arthritis 15 15
Fluid Discharge 14 14
Thrombosis/Thrombus 13 13
Sepsis 11 11
Metal Related Pathology 10 10
Bacterial Infection 9 9
Foreign Body Embolism 9 9
Hemorrhage/Bleeding 8 8
Inflammation 7 7
Death 7 7
Fistula 7 7
Skin Inflammation/ Irritation 6 6
Wound Dehiscence 6 6
Joint Laxity 4 4
Device Embedded In Tissue or Plaque 4 4
Muscular Rigidity 4 4
Cyst(s) 4 4

Recalls
Manufacturer Recall Class Date Posted
1 Howmedica Osteonics Corp. II Feb-16-2022
2 Medicalplastic S.R.L. II Nov-17-2021
3 New Standard Device Inc II Jun-09-2023
4 New Standard Device Inc II Aug-29-2022
5 New Standard Device Inc II Jun-03-2022
6 OrthoPediatrics Corp II Sep-06-2022
7 Stryker GmbH II Jun-27-2024
8 Stryker GmbH II Mar-01-2023
9 Wishbone Medical, Inc. II Feb-07-2023
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