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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 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
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 1
BODYCAD LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
BONEBRIDGE AG
  SUBSTANTIALLY EQUIVALENT 4
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
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 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 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 1
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
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 2
SKELETAL DYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 5
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 10
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
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 3
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 3356 3356
2020 2790 2790
2021 2443 2443
2022 1700 1703
2023 2058 2058
2024 1300 1302

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 6472 6476
Break 2199 2201
Fracture 1077 1079
Device-Device Incompatibility 672 672
Migration 600 600
Insufficient Information 283 283
Appropriate Term/Code Not Available 245 245
No Apparent Adverse Event 210 210
Material Twisted/Bent 210 210
Loosening of Implant Not Related to Bone-Ingrowth 157 157
Migration or Expulsion of Device 148 148
Material Deformation 140 140
Positioning Failure 131 131
Device Slipped 124 124
Use of Device Problem 118 118
Device Dislodged or Dislocated 112 112
Patient Device Interaction Problem 109 109
Detachment of Device or Device Component 87 87
Material Fragmentation 75 75
Patient-Device Incompatibility 74 74
Delivered as Unsterile Product 70 70
Defective Device 66 66
Entrapment of Device 59 59
Unintended Movement 56 56
Physical Resistance/Sticking 55 55
Corroded 53 53
Manufacturing, Packaging or Shipping Problem 49 49
Osseointegration Problem 47 47
Off-Label Use 46 46
Tear, Rip or Hole in Device Packaging 46 46
Difficult to Remove 45 45
Loose or Intermittent Connection 43 43
Packaging Problem 39 39
Difficult to Insert 37 37
Inadequacy of Device Shape and/or Size 36 36
Mechanical Problem 36 36
Malposition of Device 35 35
Material Integrity Problem 35 35
Improper or Incorrect Procedure or Method 30 30
Unstable 29 29
Fitting Problem 29 29
Crack 29 29
Positioning Problem 28 28
Connection Problem 27 27
Noise, Audible 26 26
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 1820 1820
Non-union Bone Fracture 1777 1778
Pain 1695 1696
Failure of Implant 1465 1467
Unspecified Infection 1222 1223
Insufficient Information 825 825
Bone Fracture(s) 767 768
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 403 403
Loss of Range of Motion 398 398
Discomfort 385 385
No Consequences Or Impact To Patient 347 347
Post Operative Wound Infection 340 340
Necrosis 339 339
Foreign Body In Patient 252 252
Nerve Damage 243 243
Implant Pain 216 216
No Information 195 195
Skin Inflammation/ Irritation 189 189
Malunion of Bone 177 177
Physical Asymmetry 173 173
Arthritis 160 160
Wound Dehiscence 155 155
Hypersensitivity/Allergic reaction 135 135
Swelling/ Edema 132 132
Unspecified Tissue Injury 116 116
No Patient Involvement 110 110
Device Embedded In Tissue or Plaque 104 104
Muscular Rigidity 79 79
Muscle/Tendon Damage 75 75
Swelling 69 69
Hematoma 67 67
Osteolysis 66 66
Deformity/ Disfigurement 64 64
Fall 62 62
Inflammation 55 55
Reaction 54 54
Irritation 53 53
Skin Irritation 51 51
Joint Dislocation 51 51
Dysphagia/ Odynophagia 48 48
Hypoesthesia 48 48
Numbness 41 41
Ossification 41 41
Tissue Damage 41 41
Unspecified Musculoskeletal problem 40 40
Hemorrhage/Bleeding 36 37

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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