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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device plate, fixation, bone
Product CodeHRS
Regulation Number 888.3030
Device Class 2


Premarket Reviews
ManufacturerDecision
4WEB MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
A PLUS BIOTECHNOLOGY CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
AAP IMPLANTATE AG
  SUBSTANTIALLY EQUIVALENT 5
ACUMED LLC
  SUBSTANTIALLY EQUIVALENT 2
ADDITIVE ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX INC.
  SUBSTANTIALLY EQUIVALENT 13
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 1
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
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 8
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
FOOTBRIDGE MEDICAL
  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 3
GLW MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
GM DOS REIS INDUSTRIA E COMERCIO LTDA
  SUBSTANTIALLY EQUIVALENT 5
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 10
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 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 12
MEDLINE INDUSTIRES, LP
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE INDUSTRIES, LP
  SUBSTANTIALLY EQUIVALENT 2
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 5
NEXTREMITY SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 3
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 CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SKELETAL DYNAMICS INC
  SUBSTANTIALLY EQUIVALENT 3
SKELETAL DYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 6
SKY SURGICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW
  SUBSTANTIALLY EQUIVALENT 2
SMITH & NEPHEW, INC
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 5
STRYKER
  SUBSTANTIALLY EQUIVALENT 1
STRYKER GMBH
  SUBSTANTIALLY EQUIVALENT 11
SYNTHES (USA) PRODUCTS LLC
  SUBSTANTIALLY EQUIVALENT 2
SYNTHES (USA) PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 3
SYNTHES GMBH
  SUBSTANTIALLY EQUIVALENT 2
TDM CO. LTD.
  SUBSTANTIALLY EQUIVALENT 2
TDM CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
TECHFIT DIGITAL SURGERY INC.
  SUBSTANTIALLY EQUIVALENT 1
THE ORTHOPAEDIC IMPLANT COMPANY
  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 1
TRIMED, INC.
  SUBSTANTIALLY EQUIVALENT 5
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 2
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
2019 3357 3357
2020 2790 2790
2021 2443 2443
2022 1700 1703
2023 2058 2058
2024 1749 1751

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 6623 6627
Break 2288 2290
Fracture 1134 1136
Device-Device Incompatibility 714 714
Migration 613 613
Insufficient Information 285 285
Appropriate Term/Code Not Available 245 245
Material Twisted/Bent 234 234
No Apparent Adverse Event 214 214
Loosening of Implant Not Related to Bone-Ingrowth 161 161
Material Deformation 148 148
Migration or Expulsion of Device 148 148
Positioning Failure 134 134
Device Slipped 126 126
Use of Device Problem 118 118
Device Dislodged or Dislocated 114 114
Patient Device Interaction Problem 112 112
Detachment of Device or Device Component 93 93
Delivered as Unsterile Product 91 91
Patient-Device Incompatibility 91 91
Material Fragmentation 75 75
Defective Device 67 67
Tear, Rip or Hole in Device Packaging 63 63
Entrapment of Device 60 60
Physical Resistance/Sticking 59 59
Unintended Movement 57 57
Corroded 54 54
Off-Label Use 51 51
Manufacturing, Packaging or Shipping Problem 49 49
Osseointegration Problem 47 47
Difficult to Remove 46 46
Loose or Intermittent Connection 43 43
Packaging Problem 39 39
Difficult to Insert 37 37
Material Integrity Problem 36 36
Mechanical Problem 36 36
Inadequacy of Device Shape and/or Size 36 36
Improper or Incorrect Procedure or Method 32 32
Malposition of Device 31 31
Positioning Problem 30 30
Crack 30 30
Fitting Problem 29 29
Unstable 29 29
Connection Problem 28 28
Noise, Audible 22 22
Naturally Worn 21 21
Device Contaminated During Manufacture or Shipping 21 21
Loss of or Failure to Bond 19 19
Inaccurate Information 18 18
Unsealed Device Packaging 17 17

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 2087 2087
No Clinical Signs, Symptoms or Conditions 1939 1939
Non-union Bone Fracture 1827 1828
Pain 1754 1755
Failure of Implant 1510 1512
Unspecified Infection 1262 1263
Insufficient Information 894 894
Bone Fracture(s) 780 781
Injury 493 493
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 438 438
No Known Impact Or Consequence To Patient 419 419
Impaired Healing 406 406
Loss of Range of Motion 400 400
Discomfort 391 391
Post Operative Wound Infection 350 350
No Consequences Or Impact To Patient 347 347
Necrosis 345 345
Foreign Body In Patient 264 264
Nerve Damage 256 256
Skin Inflammation/ Irritation 223 223
Implant Pain 222 222
No Information 195 195
Malunion of Bone 183 183
Physical Asymmetry 177 177
Arthritis 170 170
Wound Dehiscence 160 160
Swelling/ Edema 139 139
Hypersensitivity/Allergic reaction 138 138
Unspecified Tissue Injury 122 122
No Patient Involvement 110 110
Device Embedded In Tissue or Plaque 104 104
Muscular Rigidity 81 81
Muscle/Tendon Damage 77 77
Hematoma 70 70
Osteolysis 69 69
Fall 69 69
Swelling 69 69
Deformity/ Disfigurement 65 65
Inflammation 58 58
Reaction 55 55
Irritation 53 53
Skin Irritation 51 51
Joint Dislocation 51 51
Dysphagia/ Odynophagia 48 48
Hypoesthesia 48 48
Numbness 45 45
Ossification 42 42
Tissue Damage 41 41
Unspecified Musculoskeletal problem 41 41
Hemorrhage/Bleeding 39 40

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