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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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 2
4WEB, INC.
  SUBSTANTIALLY EQUIVALENT 1
A PLUS BIOTECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
AAP IMPLANTATE AG
  SUBSTANTIALLY EQUIVALENT 5
ACUMED LLC
  SUBSTANTIALLY EQUIVALENT 2
ADDITIVE ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
ADDITIVE ORTHOPAEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ADVANCED ORTHOPAEDIC SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ADVANCED ORTHOPAEDIC SOLUTIONS, INC. (AOS)
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX INC.
  SUBSTANTIALLY EQUIVALENT 12
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 2
AUXEIN MEDICAL PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 4
AUXEIN MEDICAL PVT. LTD
  SUBSTANTIALLY EQUIVALENT 1
AVANTI ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOMET INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOMET MICOFIXATION
  SUBSTANTIALLY EQUIVALENT 2
BIOMET MICROFIXATION
  SUBSTANTIALLY EQUIVALENT 4
BODYCAD LABORATORIES INC.
  SUBSTANTIALLY EQUIVALENT 1
BODYCAD LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
BONEBRIDGE AG
  SUBSTANTIALLY EQUIVALENT 5
CARBOFIX ORTHOPEDICS LTD.
  SUBSTANTIALLY EQUIVALENT 1
CARBOFIX ORTHOPEDICS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
CHANGZHOU GEASURE MEDICAL APPARATUS AND INSTRUMENTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
CITIEFFE S.R.L.
  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 9
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
EXTREMITY MEDICAL, LLC.
  SUBSTANTIALLY EQUIVALENT 2
FIELD ORTHOPAEDICS PTY LTD
  SUBSTANTIALLY EQUIVALENT 1
FIXIER, S.A. DE C.V.
  SUBSTANTIALLY EQUIVALENT 1
FORMA MEDICAL, INC.
  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 4
GLW MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
GM DOS REIS INDUSTRIA E COMERCIO LTDA
  SUBSTANTIALLY EQUIVALENT 3
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
  SUBSTANTIALLY EQUIVALENT 1
IN2BONES USA, LLC
  SUBSTANTIALLY EQUIVALENT 12
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 11
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 3
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 14
MEDLINE INDUSTIRES, LP
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDLINE INDUSTRIES, LP
  SUBSTANTIALLY EQUIVALENT 2
MERIL HEALTHCARE PVT. LTD.
  SUBSTANTIALLY EQUIVALENT 1
MIAMI DEVICE SOLUTIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
MICROWARE PRECISION CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
MIRUS, LLC
  SUBSTANTIALLY EQUIVALENT 2
NEBULA SURGICAL PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
NEOSTEO
  SUBSTANTIALLY EQUIVALENT 1
NETBIOLOGICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
NEWCLIP TECHNICS
  SUBSTANTIALLY EQUIVALENT 8
NEXTREMITY SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 4
NOVASTEP
  SUBSTANTIALLY EQUIVALENT 1
NVISION BIOMEDICAL TECHNOLOGIES, INC
  SUBSTANTIALLY EQUIVALENT 2
ORTHO LIFE SYSTEMS PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
ORTHO SOLUTIONS UK LTD
  SUBSTANTIALLY EQUIVALENT 2
ORTHOFIX SRL
  SUBSTANTIALLY EQUIVALENT 3
ORTHONOVIS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPAEDIC IMPLANT COMPANY
  SUBSTANTIALLY EQUIVALENT 3
ORTHOPEDIATRICS, CORP
  SUBSTANTIALLY EQUIVALENT 1
OSTEOMED
  SUBSTANTIALLY EQUIVALENT 1
OSTEONIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28, INC.
  SUBSTANTIALLY EQUIVALENT 5
PIONEER SURGICAL TECHNOLOGY, INC D.B.A RESOLVE SURGICAL TECH
  SUBSTANTIALLY EQUIVALENT 1
PIONEER SURGICAL TECHNOLOGY, INC., DBA RTI SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
RIVERPOINT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
S H PITKAR ORTHOTOOLS PVT LTD.
  SUBSTANTIALLY EQUIVALENT 1
SIG MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
SIG MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SKELETAL DYNAMICS INC
  SUBSTANTIALLY EQUIVALENT 3
SKELETAL DYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 5
SKELETAL DYNAMICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
SKY SURGICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW
  SUBSTANTIALLY EQUIVALENT 2
SMITH & NEPHEW, INC
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 7
STRYKER
  SUBSTANTIALLY EQUIVALENT 1
STRYKER GMBH
  SUBSTANTIALLY EQUIVALENT 13
STUCKENBROCK MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES (USA) LLC
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES (USA) PRODUCTS LLC
  SUBSTANTIALLY EQUIVALENT 2
SYNTHES (USA) PRODUCTS LLC/DEPUY ORTHOPAEDICS INC
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES (USA) PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 4
SYNTHES GMBH
  SUBSTANTIALLY EQUIVALENT 2
TDM CO. LTD.
  SUBSTANTIALLY EQUIVALENT 3
TDM CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
TECHFIT DIGITAL SURGERY INC.
  SUBSTANTIALLY EQUIVALENT 1
THE ORTHOPAEDIC IMPLANT COMPANY
  SUBSTANTIALLY EQUIVALENT 1
TORNIER INC.
  SUBSTANTIALLY EQUIVALENT 2
TREACE MEDICAL CONCEPTS INC.
  SUBSTANTIALLY EQUIVALENT 2
TREACE MEDICAL CONCEPTS, INC.
  SUBSTANTIALLY EQUIVALENT 5
TRIDENT ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 1
TRILLIANT SURGICAL
  SUBSTANTIALLY EQUIVALENT 2
TRIMED, INC
  SUBSTANTIALLY EQUIVALENT 1
TRIMED, INC.
  SUBSTANTIALLY EQUIVALENT 4
TRUEMED GROUP LLC
  SUBSTANTIALLY EQUIVALENT 2
TYBER MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 2
TYBER MEDICAL, LLC
  SUBSTANTIALLY EQUIVALENT 2
TYBER MEDICAL, LLC.
  SUBSTANTIALLY EQUIVALENT 4
VILEX LLC
  SUBSTANTIALLY EQUIVALENT 3
VILEX, LLC
  SUBSTANTIALLY EQUIVALENT 1
WISHBONE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 3
ZIMMER GMBH
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER SWITZERLAND MANUFACTURING GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 2663 2663
2019 3357 3357
2020 2790 2790
2021 2443 2443
2022 1700 1703
2023 2058 2058
2024 1631 1633

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 7402 7406
Break 2803 2805
Fracture 1335 1337
Device-Device Incompatibility 754 754
Migration 653 653
Insufficient Information 418 418
Appropriate Term/Code Not Available 307 307
Material Twisted/Bent 254 254
No Apparent Adverse Event 212 212
Migration or Expulsion of Device 206 206
Loosening of Implant Not Related to Bone-Ingrowth 165 165
Device Dislodged or Dislocated 157 157
Material Deformation 157 157
Device Slipped 146 146
Use of Device Problem 136 136
Positioning Failure 134 134
Patient-Device Incompatibility 128 128
Detachment of Device or Device Component 118 118
Patient Device Interaction Problem 114 114
Delivered as Unsterile Product 113 113
Physical Resistance/Sticking 107 107
Manufacturing, Packaging or Shipping Problem 92 92
Corroded 87 87
Material Fragmentation 85 85
Packaging Problem 84 84
Mechanical Problem 74 74
Defective Device 66 66
Entrapment of Device 63 63
Unintended Movement 63 63
Tear, Rip or Hole in Device Packaging 63 63
Loose or Intermittent Connection 59 59
Device Operates Differently Than Expected 58 58
Difficult to Remove 55 55
Malposition of Device 54 54
Off-Label Use 53 53
Osseointegration Problem 49 49
Difficult to Insert 46 46
Inadequacy of Device Shape and/or Size 46 46
Improper or Incorrect Procedure or Method 43 43
Positioning Problem 42 42
Device Contaminated During Manufacture or Shipping 40 40
Fitting Problem 39 39
Crack 37 37
Material Integrity Problem 37 37
Separation Failure 36 36
Unstable 36 36
Connection Problem 35 35
Material Discolored 34 34
Noise, Audible 29 29
Device Inoperable 28 28

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 2610 2610
Pain 2126 2127
Non-union Bone Fracture 1998 1999
No Clinical Signs, Symptoms or Conditions 1917 1917
Failure of Implant 1692 1694
Unspecified Infection 1471 1472
Bone Fracture(s) 975 976
Insufficient Information 876 876
No Known Impact Or Consequence To Patient 704 704
Impaired Healing 558 558
Injury 547 547
No Consequences Or Impact To Patient 542 542
Loss of Range of Motion 447 447
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 439 439
Discomfort 432 432
No Information 396 396
Post Operative Wound Infection 355 355
Necrosis 354 354
Foreign Body In Patient 293 293
Nerve Damage 276 276
No Patient Involvement 253 253
Implant Pain 220 220
Skin Inflammation/ Irritation 217 217
Wound Dehiscence 182 182
Malunion of Bone 178 178
Physical Asymmetry 175 175
Arthritis 174 174
Hypersensitivity/Allergic reaction 165 165
Swelling/ Edema 139 139
Device Embedded In Tissue or Plaque 134 134
Unspecified Tissue Injury 121 121
Swelling 119 119
Reaction 84 84
Fall 83 83
Muscular Rigidity 82 82
Muscle/Tendon Damage 77 77
Osteolysis 76 76
Irritation 76 76
Hematoma 75 75
Deformity/ Disfigurement 70 70
Inflammation 62 62
Skin Irritation 61 61
Joint Dislocation 57 57
Dysphagia/ Odynophagia 53 53
Tissue Damage 52 52
Hypoesthesia 51 51
Not Applicable 47 47
Hemorrhage/Bleeding 46 47
Numbness 44 44
Ossification 43 43

Recalls
Manufacturer Recall Class Date Posted
1 Acumed LLC II Feb-29-2024
2 Arthrex, Inc. II Apr-09-2021
3 Arthrex, Inc. II Jul-29-2020
4 Biomet II Jun-09-2020
5 Biomet, Inc. II Jan-21-2021
6 Epic Extremity, LLC II May-15-2018
7 Flower Orthopedics Corporation II Oct-06-2021
8 Flower Orthopedics Corporation II Aug-12-2020
9 GRAMERCY EXTREMITY ORTHOPEDICS II Apr-17-2023
10 I.T.S. GmbH II Jun-04-2019
11 K2M, Inc II Apr-12-2021
12 Miami Device Solutions, LLC. II Dec-05-2019
13 NewDeal SA II Jul-16-2018
14 Nextremity Solutions II Feb-11-2020
15 Nextremity Solutions II Nov-22-2019
16 Orthofix, Inc II Jun-07-2018
17 Paragon 28, Inc. II Jul-25-2022
18 Smith & Nephew, Inc. II Feb-01-2022
19 Smith & Nephew, Inc. II Dec-10-2021
20 Smith & Nephew, Inc. II Nov-18-2021
21 Smith & Nephew, Inc. II Sep-09-2020
22 Smith & Nephew, Inc. II Jan-24-2018
23 Smith & Nephew, Inc. II Jan-19-2018
24 Stryker GmbH II Jan-07-2020
25 Synthes (USA) Products LLC II Mar-01-2024
26 Synthes (USA) Products LLC II Aug-17-2020
27 Synthes, Inc. II Jan-29-2020
28 Toby Orthopaedics, Inc. II Dec-04-2019
29 Treace Medical Concepts, Inc. II Aug-23-2024
30 TriMed Inc. II Jan-31-2024
31 TriMed Inc. II Nov-13-2019
32 TriMed Inc. II Oct-10-2019
33 TriMed Inc. II Apr-23-2019
34 TriMed Inc. II Aug-18-2018
35 Wishbone Medical, Inc. II Jun-04-2021
36 Wright Medical Technology Inc II Dec-17-2021
37 Wright Medical Technology, Inc. II Apr-26-2023
38 Wright Medical Technology, Inc. II Feb-24-2023
39 Wright Medical Technology, Inc. II Mar-15-2022
40 Wright Medical Technology, Inc. II Feb-25-2022
41 Wright Medical Technology, Inc. II Dec-20-2021
42 Wright Medical Technology, Inc. II Nov-25-2019
43 Zimmer Biomet, Inc. II Nov-07-2019
44 Zimmer Biomet, Inc. II Aug-31-2018
45 Zimmer Biomet, Inc. II Apr-03-2018
46 Zimmer, Inc. II Jul-28-2023
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