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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
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 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
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 SRL
  SUBSTANTIALLY EQUIVALENT 1
ORTHONOVIS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPAEDIC IMPLANT COMPANY
  SUBSTANTIALLY EQUIVALENT 2
ORTHOPEDIATRICS CORP.
  SUBSTANTIALLY EQUIVALENT 2
ORTHOSPIN
  SUBSTANTIALLY EQUIVALENT 1
ORTHOSPIN LTD
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28, INC
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28, INC.
  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 271 271

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1774 1774
Break 725 725
Migration 446 447
Device-Device Incompatibility 411 411
Fracture 157 157
Material Twisted/Bent 87 87
Mechanical Problem 71 71
Material Deformation 56 56
Device Slipped 55 55
Insufficient Information 53 53
No Apparent Adverse Event 51 51
Migration or Expulsion of Device 48 48
Mechanical Jam 42 42
Use of Device Problem 41 41
Appropriate Term/Code Not Available 41 41
Manufacturing, Packaging or Shipping Problem 24 24
Loosening of Implant Not Related to Bone-Ingrowth 24 24
Crack 23 23
Defective Device 22 22
Detachment of Device or Device Component 21 21
Entrapment of Device 20 20
Corroded 19 19
Loss of Osseointegration 16 16
Physical Resistance/Sticking 14 14
Difficult to Advance 13 13
Material Integrity Problem 12 12
Unintended Movement 11 11
Mechanics Altered 10 10
Improper or Incorrect Procedure or Method 10 10
Device Contaminated During Manufacture or Shipping 9 9
Connection Problem 8 8
Naturally Worn 8 8
Positioning Failure 7 7
Unintended System Motion 7 7
Failure to Osseointegrate 6 6
Material Fragmentation 6 6
Device Dislodged or Dislocated 6 6
Failure to Cut 5 5
Loose or Intermittent Connection 5 5
Material Discolored 5 5
Device Difficult to Setup or Prepare 5 5
Off-Label Use 5 5
Difficult to Remove 4 4
Material Separation 4 4
Degraded 4 4
Difficult or Delayed Positioning 4 4
Patient-Device Incompatibility 4 4
Device Damaged Prior to Use 4 4
Incomplete or Inadequate Connection 4 4
Patient Device Interaction Problem 4 4
Positioning Problem 3 3
Failure to Align 3 3
Component Missing 3 3
Contamination /Decontamination Problem 3 3
Device Markings/Labelling Problem 3 3
Device Damaged by Another Device 3 3
Disconnection 3 3
Difficult to Insert 3 3
Unstable 3 3
Material Frayed 2 2
Malposition of Device 2 2
Fitting Problem 2 2
Device Difficult to Maintain 2 2
Unclear Information 2 2
Therapeutic or Diagnostic Output Failure 1 1
Device Handling Problem 1 1
Material Split, Cut or Torn 1 1
Failure to Eject 1 1
Activation Problem 1 1
Difficult or Delayed Separation 1 1
Premature Separation 1 1
Defective Component 1 1
Solder Joint Fracture 1 1
Dull, Blunt 1 1
Expiration Date Error 1 1
Application Program Problem 1 1
Deformation Due to Compressive Stress 1 1
Calibration Problem 1 1
Chemical Problem 1 1
Activation, Positioning or Separation Problem 1 1
Difficult to Open or Close 1 1
Material Protrusion/Extrusion 1 1
Packaging Problem 1 1
Inflation Problem 1 1
Unintended Ejection 1 1
Loss of or Failure to Bond 1 1
Use of Incorrect Control/Treatment Settings 1 1
Inadequacy of Device Shape and/or Size 1 1
Overheating of Device 1 1
Unsealed Device Packaging 1 1
Material Too Rigid or Stiff 1 1
Misassembled 1 1
Nonstandard Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 771 771
No Clinical Signs, Symptoms or Conditions 761 761
Non-union Bone Fracture 436 436
Pain 408 408
Failure of Implant 362 362
Bone Fracture(s) 341 341
Unspecified Infection 257 257
Necrosis 234 234
Insufficient Information 216 217
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 213 213
No Consequences Or Impact To Patient 164 164
Injury 146 146
Post Operative Wound Infection 143 143
Physical Asymmetry 117 117
No Patient Involvement 85 85
No Known Impact Or Consequence To Patient 80 80
Impaired Healing 60 60
Loss of Range of Motion 51 51
Fall 50 50
Malunion of Bone 50 50
Unspecified Tissue Injury 41 41
Discomfort 37 37
Limb Fracture 33 33
Foreign Body In Patient 30 30
Deformity/ Disfigurement 30 30
Hypersensitivity/Allergic reaction 27 27
Joint Dislocation 25 25
Nerve Damage 23 23
Hematoma 22 22
Swelling/ Edema 22 22
Arthritis 17 17
Wound Dehiscence 16 16
Implant Pain 13 13
Thrombosis/Thrombus 12 12
No Information 11 11
Fluid Discharge 11 11
Reaction 11 11
Sepsis 11 11
Blood Loss 10 10
Ambulation Difficulties 9 9
Foreign Body Embolism 9 9
Skin Erosion 9 9
Inflammation 9 9
Bacterial Infection 8 8
Metal Related Pathology 8 8
Device Embedded In Tissue or Plaque 8 8
Death 7 7
Fistula 7 7
Hemorrhage/Bleeding 7 7
Patient Problem/Medical Problem 6 6
Skin Inflammation/ Irritation 6 6
Not Applicable 5 5
Pulmonary Embolism 5 5
Perforation 5 5
Thrombosis 5 5
Cellulitis 4 4
Cyst(s) 4 4
Muscular Rigidity 3 3
Myocardial Infarction 3 3
Purulent Discharge 3 3
Weakness 3 3
Ulcer 3 3
Numbness 3 3
Spinal Cord Injury 3 3
Osteolysis 3 3
Hypoesthesia 3 3
Burning Sensation 2 2
Tingling 2 2
Tissue Damage 2 2
Swelling 2 2
Stroke/CVA 2 2
Abscess 2 2
Anemia 2 2
Erosion 2 2
Paralysis 2 2
Fever 2 2
Foreign Body Sensation in Eye 2 2
Irritability 2 2
Inadequate Osseointegration 2 2
Limited Mobility Of The Implanted Joint 2 2
Unspecified Kidney or Urinary Problem 2 2
Tissue Breakdown 1 1
Thromboembolism 1 1
Cancer 1 1
Neuralgia 1 1
Embolism/Embolus 1 1
Drug Resistant Bacterial Infection 1 1
Decreased Appetite 1 1
Osteomyelitis 1 1
Unequal Limb Length 1 1
Unspecified Musculoskeletal problem 1 1
Heart Failure/Congestive Heart Failure 1 1
Unspecified Heart Problem 1 1
Subluxation 1 1
Joint Laxity 1 1
Joint Contracture 1 1
Ischemia 1 1
Internal Organ Perforation 1 1
Calcium Deposits/Calcification 1 1
Ossification 1 1

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 Orthofix Srl II Nov-14-2019
8 Stryker GmbH II Jun-27-2024
9 Stryker GmbH II Mar-01-2023
10 Wishbone Medical, Inc. II Feb-07-2023
11 Zimmer Biomet, Inc. II Nov-22-2019
12 Zimmer Biomet, Inc. II Nov-07-2019
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