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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pin, fixation, smooth
Product CodeHTY
Regulation Number 888.3040
Device Class 2


Premarket Reviews
ManufacturerDecision
4WEB MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
4WEB, INC.
  SUBSTANTIALLY EQUIVALENT 1
A.M. SURGICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
ADDITIVE ORTHOPAEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
APEX TOOLS & ORTHOPEDICS CO.
  SUBSTANTIALLY EQUIVALENT 2
AREX USA
  SUBSTANTIALLY EQUIVALENT 1
AREX USA LLC
  SUBSTANTIALLY EQUIVALENT 1
ARMIS BIOPHARMA, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARROW PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARROWHEAD MEDICAL DEVICE TECHNOLOGIES LLC
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX INC.
  SUBSTANTIALLY EQUIVALENT 2
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 7
BIO2 TECHNOLOGIES, INC
  SUBSTANTIALLY EQUIVALENT 1
BIOMEDICAL ENT., INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOMEDICAL ENTERPRISES, INC
  SUBSTANTIALLY EQUIVALENT 1
BIOPRO, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIORETEC LTD.
  SUBSTANTIALLY EQUIVALENT 1
CONMED CORPORATION, LARGO
  SUBSTANTIALLY EQUIVALENT 1
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
  SUBSTANTIALLY EQUIVALENT 1
ELECTRO-SPEC, INC
  SUBSTANTIALLY EQUIVALENT 1
EVERGREEN ORTHOPEDIC RESEARCH LAB
  SUBSTANTIALLY EQUIVALENT 1
GRAHAM MEDICAL TECHNOLOGIES, L.L.C. (D.B.A.GRAMEDICA)
  SUBSTANTIALLY EQUIVALENT 1
HOWMEDICA OSTEONICS CORP
  SUBSTANTIALLY EQUIVALENT 1
IN2BONES SAS
  SUBSTANTIALLY EQUIVALENT 2
IN2BONES USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
INION OY
  SUBSTANTIALLY EQUIVALENT 1
INTELIVATION
  SUBSTANTIALLY EQUIVALENT 1
LIMACORPORATE S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
MEDARTIS AG
  SUBSTANTIALLY EQUIVALENT 1
MEMOMETAL TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 2
METRIC MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEWCLIP TECHNICS
  SUBSTANTIALLY EQUIVALENT 1
NEWDEAL SAS
  SUBSTANTIALLY EQUIVALENT 1
NOVASTEP
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX SRL
  SUBSTANTIALLY EQUIVALENT 1
ORTHOHELIX SURGICAL DESIGNS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ORTHOPEDIATRICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
OSSIO LTD.
  SUBSTANTIALLY EQUIVALENT 6
PACIFIC INSTRUMENTS
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHALANX INNOVATIONS
  SUBSTANTIALLY EQUIVALENT 1
PRECIFIT MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 1
RESTOR3D
  SUBSTANTIALLY EQUIVALENT 1
SKELETAL DYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SMT SCHILLING METALLTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 1
SPINAL RESOURCES INC
  SUBSTANTIALLY EQUIVALENT 1
STRYKER ENDOSCOPY
  SUBSTANTIALLY EQUIVALENT 1
STRYKER GMBH
  SUBSTANTIALLY EQUIVALENT 1
STRYKER TRAUMA GMBH
  SUBSTANTIALLY EQUIVALENT 2
SYNCHRO MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
SYNTORR INC
  SUBSTANTIALLY EQUIVALENT 1
TRILLIANT SURGICAL LTD
  SUBSTANTIALLY EQUIVALENT 1
TYBER MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
VERTICOR, LTD
  SUBSTANTIALLY EQUIVALENT 1
WISHBONE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 2
XIROS LTD
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 149 149
2015 121 121
2016 128 128
2017 82 82
2018 138 138
2019 222 222
2020 210 210
2021 148 148
2022 95 95
2023 155 155
2024 83 83

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 440 440
Break 387 387
Fracture 111 111
Detachment of Device or Device Component 53 53
Mechanical Jam 52 52
Insufficient Information 46 46
Device Operates Differently Than Expected 43 43
Material Deformation 27 27
Appropriate Term/Code Not Available 27 27
Migration or Expulsion of Device 26 26
Material Twisted/Bent 23 23
Device-Device Incompatibility 18 18
Material Fragmentation 18 18
Entrapment of Device 17 17
Migration 17 17
Material Split, Cut or Torn 17 17
Defective Device 15 15
Loose or Intermittent Connection 15 15
Use of Device Problem 15 15
Device Slipped 14 14
Unknown (for use when the device problem is not known) 13 13
Detachment Of Device Component 13 13
Malposition of Device 13 13
Device Dislodged or Dislocated 13 13
Patient-Device Incompatibility 12 12
Physical Resistance/Sticking 12 12
Activation Failure 12 12
Patient Device Interaction Problem 12 12
Bent 12 12
Improper or Incorrect Procedure or Method 11 11
Unintended Movement 11 11
Positioning Problem 10 10
Separation Failure 10 10
Difficult to Remove 9 9
Failure to Power Up 8 8
Difficult to Insert 7 7
Unstable 7 7
Failure to Advance 7 7
Failure to Osseointegrate 7 7
Component Missing 6 6
Material Rupture 6 6
Difficult to Advance 6 6
Material Protrusion/Extrusion 5 5
Product Quality Problem 5 5
Sticking 5 5
Fitting Problem 5 5
Material Frayed 5 5
Device Expiration Issue 4 4
Tear, Rip or Hole in Device Packaging 4 4
Expiration Date Error 4 4
Mechanics Altered 4 4
Failure to Align 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Therapeutic or Diagnostic Output Failure 4 4
Output Problem 4 4
Packaging Problem 4 4
Noise, Audible 4 4
Loosening of Implant Not Related to Bone-Ingrowth 3 3
Material Integrity Problem 3 3
Naturally Worn 3 3
Human-Device Interface Problem 3 3
Compatibility Problem 3 3
Device Displays Incorrect Message 3 3
Inadequacy of Device Shape and/or Size 3 3
Overheating of Device 3 3
Shelf Life Exceeded 3 3
Material Separation 3 3
Component Falling 3 3
Failure To Adhere Or Bond 3 3
Premature Activation 2 2
Off-Label Use 2 2
Delivered as Unsterile Product 2 2
Positioning Failure 2 2
Shipping Damage or Problem 2 2
Smoking 2 2
Failure to Cut 2 2
Sparking 2 2
Component or Accessory Incompatibility 2 2
Connection Problem 2 2
Difficult to Open or Close 2 2
No Apparent Adverse Event 2 2
Missing Value Reason 1 1
Device Fell 1 1
Separation Problem 1 1
Device Operational Issue 1 1
Device Packaging Compromised 1 1
Device Contaminated During Manufacture or Shipping 1 1
Extrusion 1 1
Device Contamination with Chemical or Other Material 1 1
Activation, Positioning or Separation Problem 1 1
Device Disinfection Or Sterilization Issue 1 1
Blocked Connection 1 1
Physical Property Issue 1 1
Torn Material 1 1
Scratched Material 1 1
Cut In Material 1 1
Structural Problem 1 1
Visual Prompts will not Clear 1 1
Device Damaged Prior to Use 1 1
Defective Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 198 198
No Known Impact Or Consequence To Patient 158 158
No Code Available 154 154
Unspecified Infection 118 118
No Consequences Or Impact To Patient 112 112
Pain 107 107
Failure of Implant 103 103
Insufficient Information 82 82
Non-union Bone Fracture 72 72
Foreign Body In Patient 59 59
Device Embedded In Tissue or Plaque 56 56
Injury 49 49
Swelling/ Edema 42 42
No Information 39 39
No Patient Involvement 39 39
Post Operative Wound Infection 35 35
Bone Fracture(s) 35 35
Discomfort 31 31
Implant Pain 31 31
Not Applicable 31 31
Tissue Damage 30 30
Impaired Healing 24 24
Necrosis 23 23
Swelling 21 21
Loss of Range of Motion 14 14
Cellulitis 14 14
Inflammation 13 13
Bacterial Infection 12 12
Unspecified Tissue Injury 10 10
Surgical procedure, repeated 9 9
Reaction 9 9
Fall 8 8
Hypersensitivity/Allergic reaction 8 8
Physical Asymmetry 8 8
Nerve Damage 7 7
Fever 7 7
Arthritis 6 6
Osteolysis 6 6
Deformity/ Disfigurement 6 6
Skin Inflammation/ Irritation 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Unspecified Musculoskeletal problem 5 5
Malunion of Bone 5 5
Organ Dehiscence 5 5
Joint Disorder 5 5
Sepsis 5 5
Thrombosis 5 5
Fracture, Arm 4 4
Wound Dehiscence 4 4
Patient Problem/Medical Problem 4 4
Pulmonary Embolism 3 3
Erosion 3 3
Cyst(s) 3 3
Neuropathy 3 3
Erythema 3 3
Perforation 3 3
Hematoma 3 3
Sedation 3 3
Rash 3 3
Skin Irritation 2 2
Synovitis 2 2
Therapeutic Effects, Unexpected 2 2
Complaint, Ill-Defined 2 2
Rupture 2 2
Hypoesthesia 2 2
Burning Sensation 2 2
Granuloma 2 2
Irritation 2 2
Itching Sensation 2 2
Edema 2 2
Foreign Body Reaction 2 2
Rheumatoid Arthritis 2 2
Adhesion(s) 2 2
Fluid Discharge 2 2
Limb Fracture 2 2
Joint Laxity 2 2
Joint Contracture 1 1
Paresthesia 1 1
Fibrosis 1 1
Muscle/Tendon Damage 1 1
Drug Resistant Bacterial Infection 1 1
Nervous System Injury 1 1
Test Result 1 1
Inadequate Osseointegration 1 1
Thromboembolism 1 1
Limited Mobility Of The Implanted Joint 1 1
Ambulation Difficulties 1 1
Pseudoaneurysm 1 1
Weight Changes 1 1
Paraplegia 1 1
Needle Stick/Puncture 1 1
Palpitations 1 1
Allergic reaction 1 1
Abscess 1 1
Fatigue 1 1
Embolus 1 1
Purulent Discharge 1 1
Laceration(s) 1 1
Muscle Weakness 1 1
Muscular Rigidity 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Acumed LLC II Apr-25-2014
2 Amendia, Inc II Dec-22-2016
3 Biomet, Inc. II May-26-2016
4 Brasseler USA I Lp II Jan-29-2020
5 Brasseler USA, Medical L.L.C. II Mar-01-2022
6 MicroAire Surgical Instruments, LLC II Mar-03-2017
7 MicroAire Surgical Instruments, LLC II Sep-04-2013
8 Paragon 28, Inc. II Jul-27-2022
9 Smith & Nephew Inc II Aug-10-2010
10 Stryker GmbH II Apr-27-2022
11 Synthes USA HQ, Inc. II Sep-18-2013
12 Trilliant Surgical, LLC II Apr-01-2020
13 Zimmer Biomet, Inc. II Jun-01-2018
14 Zimmer Biomet, Inc. II Oct-14-2016
15 Zimmer Inc. II Jun-26-2009
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