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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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New Search show TPLC since Back to Search Results
Device plate, fixation, bone
Product CodeHRS
Regulation Number 888.3030
Device Class 2


Premarket Reviews
ManufacturerDecision
4WEB MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
A PLUS BIOTECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
AAP IMPLANTATE AG
  SUBSTANTIALLY EQUIVALENT 5
ACUMED LLC
  SUBSTANTIALLY EQUIVALENT 1
ADDITIVE ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX INC.
  SUBSTANTIALLY EQUIVALENT 12
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 1
AUXEIN MEDICAL PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 4
AVANTI ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOMET INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET MICOFIXATION
  SUBSTANTIALLY EQUIVALENT 2
BIOMET MICROFIXATION
  SUBSTANTIALLY EQUIVALENT 3
BODYCAD LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
BONEBRIDGE AG
  SUBSTANTIALLY EQUIVALENT 3
CARBOFIX ORTHOPEDICS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
CHANGZHOU GEASURE MEDICAL APPARATUS AND INSTRUMENTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
CROSSROADS EXTEMITY SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
CROSSROADS EXTREMITY SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
CROSSROADS EXTREMITY SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 3
DEPUY SYNTHES
  SUBSTANTIALLY EQUIVALENT 7
DOUBLE MEDICAL TECHNOLOGY INC.
  SUBSTANTIALLY EQUIVALENT 2
ENDEAVOR ORTHOPAEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
EPIC EXTREMITY, LLC
  SUBSTANTIALLY EQUIVALENT 1
EXACTECH, INC
  SUBSTANTIALLY EQUIVALENT 1
EXREMITY MEDICAL, LLC.
  SUBSTANTIALLY EQUIVALENT 1
EXSOMED CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
EXTREMITY MEDICAL, LLC.
  SUBSTANTIALLY EQUIVALENT 2
FIELD ORTHOPAEDICS PTY LTD
  SUBSTANTIALLY EQUIVALENT 1
FIXIER, S.A. DE C.V.
  SUBSTANTIALLY EQUIVALENT 1
FUSION INNOVATIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
FUSION ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 1
FUSION ORTHOPEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 2
GLOBUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 3
GLW MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
GM DOS REIS INDUSTRIA E COMERCIO LTDA
  SUBSTANTIALLY EQUIVALENT 2
GM DOS REIS INDUSTRIA E COMERICO LTDA.
  SUBSTANTIALLY EQUIVALENT 1
GPC MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
GRAMERCY EXTREMITY ORTHOPEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 3
HANKIL TECH MEDICAL CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
HOSPITAL EQUIPMENT MANUFACTURING COMPANY
  SUBSTANTIALLY EQUIVALENT 1
I.T.S. GMBH
  SUBSTANTIALLY EQUIVALENT 1
IN2BONES USA, LLC
  SUBSTANTIALLY EQUIVALENT 9
INDUSTRIAS MEDICAS SAMPEDRO S.A.S
  SUBSTANTIALLY EQUIVALENT 1
INTAI TECHNOLOGY CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA LIFESCIENCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
INTRAUMA S.P.A
  SUBSTANTIALLY EQUIVALENT 1
JACE MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
JEIL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 9
JIANGSU TRAUHUI MEDICAL INSTRUMENT CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
JM LONGYEAR MANUFACTURING, LLC D.B.A. ABLE MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 1
JM LONGYEAR MANUFACTURING, LLC D/B/A ABLE MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 2
KLS MARTIN L.P.
  SUBSTANTIALLY EQUIVALENT 1
KLS-MARTIN L.P.
  SUBSTANTIALLY EQUIVALENT 2
LEITH MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
MAXXION MEDICAL, LLC / BAUMER SA
  SUBSTANTIALLY EQUIVALENT 1
MCGINLEY ORTHPAEDIC INNOVATIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDARTIS AG
  SUBSTANTIALLY EQUIVALENT 9
MEDLINE INDUSTIRES, LP
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, LP
  SUBSTANTIALLY EQUIVALENT 2
MICROWARE PRECISION CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MIRUS, LLC
  SUBSTANTIALLY EQUIVALENT 2
NEBULA SURGICAL PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
NEOSTEO
  SUBSTANTIALLY EQUIVALENT 1
NEWCLIP TECHNICS
  SUBSTANTIALLY EQUIVALENT 4
NEXTREMITY SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 3
NOVASTEP
  SUBSTANTIALLY EQUIVALENT 1
NVISION BIOMEDICAL TECHNOLOGIES, INC
  SUBSTANTIALLY EQUIVALENT 2
ORTHO SOLUTIONS UK LTD
  SUBSTANTIALLY EQUIVALENT 2
ORTHOFIX SRL
  SUBSTANTIALLY EQUIVALENT 3
ORTHOPAEDIC IMPLANT COMPANY
  SUBSTANTIALLY EQUIVALENT 3
ORTHOPEDIATRICS, CORP
  SUBSTANTIALLY EQUIVALENT 1
OSTEOMED
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28, INC.
  SUBSTANTIALLY EQUIVALENT 4
PIONEER SURGICAL TECHNOLOGY, INC D.B.A RESOLVE SURGICAL TECH
  SUBSTANTIALLY EQUIVALENT 1
PIONEER SURGICAL TECHNOLOGY, INC., DBA RTI SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
S H PITKAR ORTHOTOOLS PVT LTD.
  SUBSTANTIALLY EQUIVALENT 1
SIG MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SKELETAL DYNAMICS INC
  SUBSTANTIALLY EQUIVALENT 1
SKELETAL DYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 5
SKY SURGICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 5
STRYKER
  SUBSTANTIALLY EQUIVALENT 1
STRYKER GMBH
  SUBSTANTIALLY EQUIVALENT 9
SYNTHES (USA) PRODUCTS LLC
  SUBSTANTIALLY EQUIVALENT 2
SYNTHES (USA) PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 3
TDM CO. LTD.
  SUBSTANTIALLY EQUIVALENT 2
TECHFIT DIGITAL SURGERY INC.
  SUBSTANTIALLY EQUIVALENT 1
TORNIER INC.
  SUBSTANTIALLY EQUIVALENT 1
TREACE MEDICAL CONCEPTS INC.
  SUBSTANTIALLY EQUIVALENT 2
TREACE MEDICAL CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 4
TRILLIANT SURGICAL
  SUBSTANTIALLY EQUIVALENT 2
TRIMED, INC.
  SUBSTANTIALLY EQUIVALENT 3
TRUEMED GROUP LLC
  SUBSTANTIALLY EQUIVALENT 2
TYBER MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 2
TYBER MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 1
TYBER MEDICAL, LLC.
  SUBSTANTIALLY EQUIVALENT 4
VILEX LLC
  SUBSTANTIALLY EQUIVALENT 3
WISHBONE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 3
ZIMMER GMBH
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2019 3356 3356
2020 2790 2790
2021 2443 2443
2022 1700 1703
2023 2056 2056
2024 192 192

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5970 5972
Break 2047 2049
Fracture 963 965
Device-Device Incompatibility 618 618
Migration 536 536
Insufficient Information 271 271
Appropriate Term/Code Not Available 235 235
Material Twisted/Bent 201 201
No Apparent Adverse Event 200 200
Migration or Expulsion of Device 144 144
Loosening of Implant Not Related to Bone-Ingrowth 137 137
Material Deformation 128 128
Device Slipped 121 121
Patient Device Interaction Problem 105 105
Use of Device Problem 102 102
Positioning Failure 97 97
Device Dislodged or Dislocated 96 96
Patient-Device Incompatibility 73 73
Detachment of Device or Device Component 73 73
Material Fragmentation 62 62
Delivered as Unsterile Product 60 60
Entrapment of Device 56 56
Defective Device 55 55
Corroded 53 53
Unintended Movement 49 49
Osseointegration Problem 46 46
Manufacturing, Packaging or Shipping Problem 46 46
Physical Resistance/Sticking 45 45
Difficult to Remove 44 44
Loose or Intermittent Connection 43 43
Off-Label Use 39 39
Packaging Problem 39 39
Tear, Rip or Hole in Device Packaging 38 38
Difficult to Insert 37 37
Inadequacy of Device Shape and/or Size 35 35
Material Integrity Problem 34 34
Malposition of Device 31 31
Mechanical Problem 31 31
Crack 27 27
Connection Problem 27 27
Improper or Incorrect Procedure or Method 26 26
Unstable 25 25
Positioning Problem 25 25
Device Contaminated During Manufacture or Shipping 21 21
Naturally Worn 19 19
Loss of or Failure to Bond 19 19
Inaccurate Information 18 18
Fitting Problem 17 17
Unsealed Device Packaging 16 16
Noise, Audible 15 15
Contamination /Decontamination Problem 15 15
Separation Problem 14 14
Failure to Osseointegrate 14 14
Device Markings/Labelling Problem 13 13
Loss of Osseointegration 13 13
Device Appears to Trigger Rejection 12 12
Dull, Blunt 11 11
Incomplete or Inadequate Connection 11 11
Therapeutic or Diagnostic Output Failure 11 11
Material Separation 10 10
Mechanical Jam 9 9
Difficult to Advance 9 9
Failure to Align 8 8
Component Missing 8 8
Material Discolored 7 7
Device Damaged by Another Device 7 7
Material Protrusion/Extrusion 7 7
Output Problem 7 7
Failure to Cut 7 7
Deformation Due to Compressive Stress 6 6
Device Difficult to Maintain 6 6
Nonstandard Device 6 6
Device Difficult to Setup or Prepare 5 5
Unexpected Therapeutic Results 5 5
Failure to Advance 5 5
Degraded 4 4
Difficult or Delayed Positioning 4 4
Contamination 4 4
Flaked 4 4
Device Handling Problem 4 4
Difficult or Delayed Separation 4 4
Blocked Connection 4 4
Defective Component 4 4
Biocompatibility 3 3
Calibration Problem 3 3
Material Split, Cut or Torn 3 3
Incorrect Measurement 3 3
Material Erosion 3 3
Shipping Damage or Problem 3 3
Material Rupture 3 3
Unintended System Motion 3 3
Overheating of Device 2 2
Material Puncture/Hole 2 2
Smoking 2 2
Problem with Sterilization 2 2
Expiration Date Error 2 2
Separation Failure 2 2
Collapse 2 2
Signal Artifact/Noise 2 2
Material Frayed 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 2087 2087
Non-union Bone Fracture 1647 1648
No Clinical Signs, Symptoms or Conditions 1582 1582
Pain 1535 1535
Failure of Implant 1336 1338
Unspecified Infection 1102 1102
Bone Fracture(s) 721 722
Insufficient Information 612 612
Injury 493 493
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 436 436
No Known Impact Or Consequence To Patient 419 419
Impaired Healing 396 396
Loss of Range of Motion 378 378
Discomfort 367 367
No Consequences Or Impact To Patient 347 347
Post Operative Wound Infection 327 327
Necrosis 306 306
Nerve Damage 229 229
Foreign Body In Patient 220 220
No Information 195 195
Physical Asymmetry 167 167
Malunion of Bone 165 165
Implant Pain 155 155
Skin Inflammation/ Irritation 154 154
Arthritis 144 144
Wound Dehiscence 140 140
Hypersensitivity/Allergic reaction 124 124
Swelling/ Edema 114 114
No Patient Involvement 110 110
Device Embedded In Tissue or Plaque 98 98
Unspecified Tissue Injury 94 94
Swelling 69 69
Muscle/Tendon Damage 66 66
Osteolysis 66 66
Muscular Rigidity 65 65
Hematoma 59 59
Fall 56 56
Reaction 54 54
Irritation 53 53
Deformity/ Disfigurement 52 52
Skin Irritation 51 51
Inflammation 50 50
Joint Dislocation 49 49
Hypoesthesia 48 48
Dysphagia/ Odynophagia 48 48
Tissue Damage 41 41
Ossification 38 38
Hemorrhage/Bleeding 35 36
Numbness 32 32
Calcium Deposits/Calcification 28 28
Bacterial Infection 26 26
Osteopenia/ Osteoporosis 26 26
Scar Tissue 25 25
Pneumothorax 24 24
Adhesion(s) 24 24
Unspecified Musculoskeletal problem 22 22
Metal Related Pathology 21 21
Patient Problem/Medical Problem 21 21
Cerebrospinal Fluid Leakage 21 21
Neuropathy 20 20
Fluid Discharge 20 20
Ambulation Difficulties 19 19
Thrombosis/Thrombus 19 19
Fistula 19 19
Rash 18 18
Sepsis 18 18
Rupture 18 18
Inadequate Osseointegration 18 18
Abscess 16 16
Joint Disorder 15 15
Limb Fracture 15 15
Decreased Sensitivity 14 14
Visual Impairment 14 14
Weakness 13 13
Thrombosis 13 13
Perforation 13 13
Blood Loss 13 13
Limited Mobility Of The Implanted Joint 12 12
Paralysis 12 12
Pneumonia 12 12
Tingling 12 12
Fatigue 12 12
Foreign Body Reaction 11 11
Pulmonary Embolism 11 11
Pocket Erosion 11 11
Joint Contracture 11 11
Skin Infection 11 11
Burning Sensation 10 10
Visual Disturbances 10 10
Edema 10 10
Death 10 10
Eye Injury 10 10
Itching Sensation 9 9
Cyst(s) 9 9
Dyspnea 9 9
Cellulitis 9 9
Local Reaction 9 9
Seroma 8 8
Skin Erosion 8 8
Erosion 8 8

Recalls
Manufacturer Recall Class Date Posted
1 Arthrex, Inc. II Apr-09-2021
2 Arthrex, Inc. II Jul-29-2020
3 Biomet II Jun-09-2020
4 Biomet, Inc. II Jan-21-2021
5 Flower Orthopedics Corporation II Oct-06-2021
6 Flower Orthopedics Corporation II Aug-12-2020
7 GRAMERCY EXTREMITY ORTHOPEDICS II Apr-17-2023
8 I.T.S. GmbH II Jun-04-2019
9 K2M, Inc II Apr-12-2021
10 Miami Device Solutions, LLC. II Dec-05-2019
11 Nextremity Solutions II Feb-11-2020
12 Nextremity Solutions II Nov-22-2019
13 Paragon 28, Inc. II Jul-25-2022
14 Smith & Nephew, Inc. II Feb-01-2022
15 Smith & Nephew, Inc. II Dec-10-2021
16 Smith & Nephew, Inc. II Nov-18-2021
17 Smith & Nephew, Inc. II Sep-09-2020
18 Stryker GmbH II Jan-07-2020
19 Synthes (USA) Products LLC II Aug-17-2020
20 Synthes, Inc. II Jan-29-2020
21 Toby Orthopaedics, Inc. II Dec-04-2019
22 TriMed Inc. II Jan-31-2024
23 TriMed Inc. II Nov-13-2019
24 TriMed Inc. II Oct-10-2019
25 TriMed Inc. II Apr-23-2019
26 Wishbone Medical, Inc. II Jun-04-2021
27 Wright Medical Technology Inc II Dec-17-2021
28 Wright Medical Technology, Inc. II Apr-26-2023
29 Wright Medical Technology, Inc. II Feb-24-2023
30 Wright Medical Technology, Inc. II Mar-15-2022
31 Wright Medical Technology, Inc. II Feb-25-2022
32 Wright Medical Technology, Inc. II Dec-20-2021
33 Wright Medical Technology, Inc. II Nov-25-2019
34 Zimmer Biomet, Inc. II Nov-07-2019
35 Zimmer, Inc. II Jul-28-2023
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