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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
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 2
EXTREMITY MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
GLW MEDICAL INNOVATION
  SUBSTANTIALLY EQUIVALENT 1
LIFE SPINE INC.
  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 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 2
SEQUEL MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 2
STRYKER GMBH
  SUBSTANTIALLY EQUIVALENT 3
SURGICAL INSTRUMENT SERVICE AND SAVINGS INC
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES (USA) PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 2
VILEX LLC
  SUBSTANTIALLY EQUIVALENT 1
VILEX, LLC
  SUBSTANTIALLY EQUIVALENT 2
WISHBONE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 597 597
2019 800 800
2020 942 942
2021 961 961
2022 627 628
2023 554 554
2024 524 524
2025 125 125

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2137 2137
Break 878 878
Migration 497 498
Device-Device Incompatibility 493 493
Fracture 189 189
Material Twisted/Bent 105 105
Mechanical Problem 104 104
Insufficient Information 84 84
Material Deformation 81 81
Device Slipped 74 74
Unintended Movement 63 63
No Apparent Adverse Event 55 55
Migration or Expulsion of Device 52 52
Mechanical Jam 49 49
Use of Device Problem 49 49
Manufacturing, Packaging or Shipping Problem 45 45
Appropriate Term/Code Not Available 45 45
Crack 34 34
Device Operates Differently Than Expected 30 30
Defective Device 28 28
Loosening of Implant Not Related to Bone-Ingrowth 26 26
Detachment of Device or Device Component 26 26
Entrapment of Device 23 23
Corroded 19 19
Contamination /Decontamination Problem 17 17
Loss of Osseointegration 16 16
Physical Resistance/Sticking 14 14
Device Contaminated During Manufacture or Shipping 14 14
Difficult to Advance 13 13
Patient Device Interaction Problem 13 13
Material Integrity Problem 12 12
Mechanics Altered 11 11
Improper or Incorrect Procedure or Method 11 11
Loose or Intermittent Connection 10 10
Connection Problem 9 9
Difficult to Remove 9 9
Naturally Worn 8 8
Positioning Failure 8 8
Material Fragmentation 8 8
Material Separation 7 7
Device Dislodged or Dislocated 7 7
Unintended System Motion 7 7
Failure to Osseointegrate 7 7
Patient-Device Incompatibility 7 7
Device Inoperable 6 6
Off-Label Use 5 5
Device Damaged Prior to Use 5 5
Degraded 5 5
Difficult to Insert 5 5
Material Discolored 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 968 968
No Clinical Signs, Symptoms or Conditions 881 881
Non-union Bone Fracture 560 560
Pain 517 517
Failure of Implant 423 423
Bone Fracture(s) 406 406
Unspecified Infection 346 346
Insufficient Information 298 299
Necrosis 259 259
No Consequences Or Impact To Patient 221 221
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 214 214
No Known Impact Or Consequence To Patient 165 165
Post Operative Wound Infection 154 154
Injury 151 151
Physical Asymmetry 125 125
No Patient Involvement 112 112
Impaired Healing 95 95
Malunion of Bone 58 58
Fall 56 56
Loss of Range of Motion 56 56
Unspecified Tissue Injury 47 47
Foreign Body In Patient 43 43
Discomfort 42 42
Limb Fracture 34 34
Deformity/ Disfigurement 30 30
Hypersensitivity/Allergic reaction 27 27
Joint Dislocation 26 26
Nerve Damage 26 26
No Information 24 24
Swelling/ Edema 23 23
Hematoma 23 23
Ambulation Difficulties 21 21
Arthritis 20 20
Not Applicable 18 18
Wound Dehiscence 16 16
Implant Pain 15 15
Fluid Discharge 14 14
Blood Loss 14 14
Device Embedded In Tissue or Plaque 14 14
Thrombosis/Thrombus 13 13
Sepsis 13 13
Reaction 13 13
Bacterial Infection 11 11
Inflammation 11 11
Metal Related Pathology 10 10
Skin Erosion 9 9
Foreign Body Embolism 9 9
Paralysis 8 8
Patient Problem/Medical Problem 8 8
Hemorrhage/Bleeding 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 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 Orthofix Srl II Jun-05-2018
9 Stryker GmbH II Jun-27-2024
10 Stryker GmbH II Mar-01-2023
11 Stryker GmbH II Oct-29-2018
12 Stryker GmbH II Sep-22-2018
13 Stryker GmbH II Apr-26-2018
14 Wishbone Medical, Inc. II Feb-07-2023
15 Zimmer Biomet, Inc. II Nov-22-2019
16 Zimmer Biomet, Inc. II Nov-07-2019
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