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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
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 1
AUXEIN MEDICAL PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 4
AVANTI ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOMET INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOMET MICOFIXATION
  SUBSTANTIALLY EQUIVALENT 2
BIOMET MICROFIXATION
  SUBSTANTIALLY EQUIVALENT 3
BODYCAD LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
BONEBRIDGE AG
  SUBSTANTIALLY EQUIVALENT 3
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
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 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 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 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 13
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
NEWCLIP TECHNICS
  SUBSTANTIALLY EQUIVALENT 7
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
ORTHOPAEDIC IMPLANT COMPANY
  SUBSTANTIALLY EQUIVALENT 3
ORTHOPEDIATRICS, CORP
  SUBSTANTIALLY EQUIVALENT 1
OSTEOMED
  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
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 1
SKELETAL DYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 5
SKELETAL DYNAMICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
SKY SURGICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 7
STRYKER
  SUBSTANTIALLY EQUIVALENT 1
STRYKER GMBH
  SUBSTANTIALLY EQUIVALENT 12
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 1
TDM CO. LTD.
  SUBSTANTIALLY EQUIVALENT 3
TDM CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
TECHFIT DIGITAL SURGERY INC.
  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 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
WISHBONE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 3
ZIMMER GMBH
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2018 2663 2663
2019 3356 3356
2020 2790 2790
2021 2443 2443
2022 1700 1703
2023 2058 2058
2024 915 916

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 7178 7181
Break 2672 2674
Fracture 1243 1245
Device-Device Incompatibility 701 701
Migration 614 614
Insufficient Information 413 413
Appropriate Term/Code Not Available 307 307
Material Twisted/Bent 228 228
No Apparent Adverse Event 209 209
Migration or Expulsion of Device 205 205
Loosening of Implant Not Related to Bone-Ingrowth 155 155
Device Slipped 144 144
Material Deformation 144 144
Device Dislodged or Dislocated 143 143
Use of Device Problem 133 133
Patient Device Interaction Problem 112 112
Patient-Device Incompatibility 111 111
Detachment of Device or Device Component 106 106
Positioning Failure 106 106
Physical Resistance/Sticking 103 103
Manufacturing, Packaging or Shipping Problem 90 90
Corroded 87 87
Delivered as Unsterile Product 84 84
Packaging Problem 84 84
Material Fragmentation 82 82
Mechanical Problem 74 74
Defective Device 64 64
Unintended Movement 61 61
Entrapment of Device 61 61
Loose or Intermittent Connection 59 59
Device Operates Differently Than Expected 58 58
Difficult to Remove 54 54
Malposition of Device 50 50
Osseointegration Problem 48 48
Inadequacy of Device Shape and/or Size 46 46
Difficult to Insert 46 46
Off-Label Use 44 44
Device Contaminated During Manufacture or Shipping 40 40
Improper or Incorrect Procedure or Method 40 40
Tear, Rip or Hole in Device Packaging 40 40
Positioning Problem 39 39
Fitting Problem 38 38
Separation Failure 35 35
Material Integrity Problem 35 35
Crack 35 35
Material Discolored 34 34
Connection Problem 34 34
Unstable 32 32
Device Inoperable 28 28
Device Markings/Labelling Problem 28 28
Failure to Osseointegrate 22 22
Loss of or Failure to Bond 22 22
Unsealed Device Packaging 21 21
Naturally Worn 21 21
Failure to Align 20 20
Sharp Edges 19 19
Noise, Audible 18 18
Inaccurate Information 18 18
Dull, Blunt 18 18
Component Missing 17 17
Contamination /Decontamination Problem 16 16
Mechanics Altered 16 16
Device Contamination with Chemical or Other Material 16 16
Bent 16 16
Loss of Osseointegration 15 15
Failure to Advance 14 14
Separation Problem 14 14
Mechanical Jam 13 13
Device Appears to Trigger Rejection 13 13
Device Damaged by Another Device 12 12
Therapeutic or Diagnostic Output Failure 11 11
Material Separation 11 11
Incomplete or Inadequate Connection 11 11
Material Protrusion/Extrusion 10 10
Difficult to Advance 10 10
Biocompatibility 10 10
Device Packaging Compromised 9 9
Nonstandard Device 9 9
Failure To Adhere Or Bond 9 9
Flaked 9 9
Device Difficult to Maintain 9 9
Fail-Safe Design Failure 8 8
Output Problem 7 7
Failure to Cut 7 7
Deformation Due to Compressive Stress 7 7
Defective Component 6 6
Activation, Positioning or Separation Problem 6 6
Degraded 6 6
Device Difficult to Setup or Prepare 6 6
Peeled/Delaminated 5 5
Material Rupture 5 5
Unexpected Therapeutic Results 5 5
Installation-Related Problem 5 5
Pressure Problem 5 5
Metal Shedding Debris 4 4
Blocked Connection 4 4
Unraveled Material 4 4
Difficult To Position 4 4
Difficult or Delayed Positioning 4 4
Detachment Of Device Component 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 2610 2610
Pain 2034 2035
Non-union Bone Fracture 1926 1927
No Clinical Signs, Symptoms or Conditions 1727 1727
Failure of Implant 1577 1579
Unspecified Infection 1422 1422
Bone Fracture(s) 951 952
Insufficient Information 781 781
No Known Impact Or Consequence To Patient 704 704
Impaired Healing 555 555
Injury 547 547
No Consequences Or Impact To Patient 542 542
Loss of Range of Motion 444 444
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 439 439
Discomfort 418 418
No Information 396 396
Post Operative Wound Infection 348 348
Necrosis 346 346
Foreign Body In Patient 273 273
Nerve Damage 264 264
No Patient Involvement 253 253
Implant Pain 210 210
Malunion of Bone 176 176
Skin Inflammation/ Irritation 174 174
Wound Dehiscence 172 172
Arthritis 171 171
Physical Asymmetry 171 171
Hypersensitivity/Allergic reaction 159 159
Device Embedded In Tissue or Plaque 134 134
Swelling/ Edema 124 124
Swelling 119 119
Unspecified Tissue Injury 107 107
Reaction 83 83
Muscular Rigidity 81 81
Fall 77 77
Irritation 76 76
Osteolysis 76 76
Muscle/Tendon Damage 74 74
Hematoma 69 69
Deformity/ Disfigurement 67 67
Skin Irritation 61 61
Inflammation 58 58
Joint Dislocation 55 55
Dysphagia/ Odynophagia 53 53
Tissue Damage 52 52
Hypoesthesia 51 51
Not Applicable 47 47
Hemorrhage/Bleeding 43 44
Ossification 43 43
Numbness 40 40
Adhesion(s) 39 39
Patient Problem/Medical Problem 36 36
Unspecified Musculoskeletal problem 36 36
Calcium Deposits/Calcification 35 35
Scar Tissue 32 32
Osteopenia/ Osteoporosis 31 31
Limited Mobility Of The Implanted Joint 29 29
Ambulation Difficulties 28 28
Bacterial Infection 28 28
Rash 27 27
Rupture 27 27
Burning Sensation 26 26
Cellulitis 26 26
Inadequate Osseointegration 26 26
Pneumothorax 25 25
Fistula 24 24
Abscess 23 23
Cerebrospinal Fluid Leakage 23 23
Fluid Discharge 23 23
Metal Related Pathology 23 23
Laceration(s) 22 22
Neuropathy 22 22
Sepsis 20 20
Perforation 19 19
Thrombosis/Thrombus 19 19
Death 17 17
Erosion 17 17
Foreign Body Reaction 17 17
Erythema 15 15
Pocket Erosion 15 15
Itching Sensation 15 15
Visual Impairment 15 15
Limb Fracture 15 15
Joint Contracture 15 15
Joint Disorder 15 15
Decreased Sensitivity 14 14
Blood Loss 14 14
Thrombosis 14 14
Skin Erosion 14 14
Weakness 14 14
Pneumonia 14 14
Fatigue 14 14
Chest Pain 14 14
Pulmonary Embolism 13 13
Eye Injury 13 13
Paralysis 13 13
Tingling 12 12
Dyspnea 11 11
Skin Infection 11 11
Edema 10 10

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 TriMed Inc. II Jan-31-2024
30 TriMed Inc. II Nov-13-2019
31 TriMed Inc. II Oct-10-2019
32 TriMed Inc. II Apr-23-2019
33 TriMed Inc. II Aug-18-2018
34 Wishbone Medical, Inc. II Jun-04-2021
35 Wright Medical Technology Inc II Dec-17-2021
36 Wright Medical Technology, Inc. II Apr-26-2023
37 Wright Medical Technology, Inc. II Feb-24-2023
38 Wright Medical Technology, Inc. II Mar-15-2022
39 Wright Medical Technology, Inc. II Feb-25-2022
40 Wright Medical Technology, Inc. II Dec-20-2021
41 Wright Medical Technology, Inc. II Nov-25-2019
42 Zimmer Biomet, Inc. II Nov-07-2019
43 Zimmer Biomet, Inc. II Aug-31-2018
44 Zimmer Biomet, Inc. II Apr-03-2018
45 Zimmer, Inc. II Jul-28-2023
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